United States

&lt;p&gt;Benjamin Speich,&lt;sup&gt;1&lt;/sup&gt; Ala Taji Heravi,&lt;sup&gt;1&lt;/sup&gt; Johannes M. Schwenke,&lt;sup&gt;1&lt;/sup&gt; Christof M. Schönenberger,&lt;sup&gt;1&lt;/sup&gt; Lena Hausheer,&lt;sup&gt;1&lt;/sup&gt; Dmitry Gryaznov,&lt;sup&gt;1&lt;/sup&gt; Jason W. Busse,&lt;sup&gt;2,3&lt;/sup&gt; Manuela Covino,&lt;sup&gt;1&lt;/sup&gt; Szimonetta Lohner,&lt;sup&gt;4&lt;/sup&gt; Malena Chiaborelli,&lt;sup&gt;1&lt;/sup&gt; Ruben&lt;sup&gt; &lt;/sup&gt;Ramirez,&lt;sup&gt;1&lt;/sup&gt; Ramon Saccilotto,&lt;sup&gt;5&lt;/sup&gt; Erik von Elm,&lt;sup&gt;6&lt;/sup&gt; Arnav Agarwal,&lt;sup&gt;3&lt;/sup&gt; Julian Hirt,&lt;sup&gt;7&lt;/sup&gt; David Mall,&lt;sup&gt;1&lt;/sup&gt; Alain Amstutz,&lt;sup&gt;1&lt;/sup&gt; Selina Epp,&lt;sup&gt;1&lt;/sup&gt; Dominik Mertz,&lt;sup&gt;3&lt;/sup&gt; Anette Blümle,&lt;sup&gt;8&lt;/sup&gt; Belinda von Niederhäusern,&lt;sup&gt;9&lt;/sup&gt; Ayodele Odutayo,&lt;sup&gt;10&lt;/sup&gt; Alexandra N. Griessbach,&lt;sup&gt;1&lt;/sup&gt; Sally Hopewell,&lt;sup&gt;11&lt;/sup&gt; Matthias Briel,&lt;sup&gt;1,3&lt;/sup&gt; for the ASPIRE Study Group&lt;/p&gt;
&lt;h4&gt;Objective&lt;/h4&gt;
&lt;p&gt; Previous studies found that approximately one-third of randomized clinical trials (RCTs) were discontinued prematurely and that the most common reason for stopping early was poor recruitment of participants. To minimize research waste, it is crucial that all RCTs are registered and make their results available. Hence, we aimed to (1) assess the fate of RCTs approved by ethics committees in 2016 in terms of nonregistration, discontinuation, and nonpublication and (2) examine RCT characteristics associated with discontinuation due to poor recruitment and nonpublication of RCT results.&lt;/p&gt;
&lt;h4&gt;Design&lt;/h4&gt;
&lt;p&gt; We had access to 347 RCT protocols that were approved in 2016 by research ethics committees in the UK, Switzerland, Germany, and Canada. Key trial characteristics were extracted from approved trial protocols. &lt;span lang=&quot;de-DE&quot;&gt;Trial registration was verified using registration numbers from the protocol and by searching the &lt;/span&gt;World Health Organization&lt;span lang=&quot;de-DE&quot;&gt; International Clinical Trials Registry Platform, ClinicalTrials.gov, &lt;/span&gt;European Union Clinical Trials Register&lt;span lang=&quot;de-DE&quot;&gt;, ISRCTN, and Google; trials were deemed nonregistered if not found. We searched for full-text publications in PubMed, Google Scholar, and Scopus. Searches for both registration and publication used (&lt;/span&gt;1&lt;span lang=&quot;de-DE&quot;&gt;) full titles&lt;/span&gt;,&lt;span lang=&quot;de-DE&quot;&gt; (&lt;/span&gt;2&lt;span lang=&quot;de-DE&quot;&gt;) short titles&lt;/span&gt;,&lt;span lang=&quot;de-DE&quot;&gt; (&lt;/span&gt;3&lt;span lang=&quot;de-DE&quot;&gt;) study acronyms&lt;/span&gt;,&lt;span lang=&quot;de-DE&quot;&gt; and (&lt;/span&gt;4&lt;span lang=&quot;de-DE&quot;&gt;) the study population and intervention. &lt;/span&gt;All searches were conducted in duplicate (last search, July 2024). In case the status of an RCT was unclear, we contacted the corresponding ethics committee or the principal investigator. We reported the proportion of nonregistered RCTs, discontinued RCTs (including reason for early discontinuation), and nonpublished RCTs (considering peer-reviewed publications and results in trial registries). &lt;/p&gt;
&lt;h4&gt;Results&lt;/h4&gt;
&lt;p&gt; Of the 347 included RCTs from 2016, 20 (5.8%) were nonregistered (industry-sponsored RCTs, 5 of 181 [2.8%]; nonindustry RCTs, 15 of 166 [9.0%]). Approximately one-third of RCTs (108 of 347 [31.1%]) were discontinued, most often due to poor recruitment (49 of 108 [45.4%]). A total of 276 of 347 RCTs (79.5%) made their results available at any source, 249 (71.8%) as a peer-reviewed publication, and 170 (49.0%) in the trial registry. Discontinued RCTs had lower result availability than completed RCTs (discontinued, 74 of 108 [68.5%]; completed, 202 of 226 [89.4%]). Results from industry-sponsored trials were more often available compared with nonindustry trials (92% vs 66%). This difference was driven by the fact that only 17 of 166 nonindustry RCTs (10.2%) reported results in trial registries compared with 153 of 181 industry trials (84.5%). The status of 4% of RCTs remained unclear despite our efforts to contact investigators.&lt;/p&gt;
&lt;h4&gt;Conclusions&lt;/h4&gt;
&lt;p&gt; Nonregistration, premature discontinuation due to poor recruitment, and nonpublication of RCT results remain major challenges, especially for nonindustry trials.&lt;/p&gt;

&lt;sup&gt;1&lt;/sup&gt;Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland, johannesmanteo.schwenke@usb.ch; &lt;sup&gt;2&lt;/sup&gt;Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada; &lt;sup&gt;3&lt;/sup&gt;Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; &lt;sup&gt;4&lt;/sup&gt;MTA–PTE Lendület Momentum Evidence in Medicine Research Group, Medical School, University of Pécs, Pécs, Hungary; &lt;sup&gt;5&lt;/sup&gt;Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland; &lt;sup&gt;6&lt;/sup&gt;Cochrane Switzerland, Centre for Primary Care and Public Health (Unisante), University of Lausanne, Lausanne, Switzerland; &lt;sup&gt;7&lt;/sup&gt;Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel and University of Basel, Basel, Switzerland; &lt;sup&gt;8&lt;/sup&gt;Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; &lt;sup&gt;9&lt;/sup&gt;Roche Pharma AG, Grenzach-Wyhlen, Germany; &lt;sup&gt;10&lt;/sup&gt;University Health Network, Division of Nephrology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; &lt;sup&gt;11&lt;/sup&gt;Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
&lt;h4&gt;Conflict of Interest Disclosures&lt;/h4&gt; Benjamin Speich and Matthias Briel received unrestricted grants from Moderna for the conduct of the COVERALL-2 and COVERALL-3 study. Benjamin Speich has received honoraria from Moderna and Roche for presenting study results not related to this work. Johannes M. Schwenke is paid by the Swiss National Science Foundation for work unrelated to this project. No other disclosures were reported.
&lt;h4&gt;Funding/Support&lt;/h4&gt; The study is supported by the Swiss Federal Office of Public Health (Matthias Briel).
&lt;h4&gt;Role of the Funder/Sponsor&lt;/h4&gt; The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the abstract; and decision to submit the abstract for presentation.
&lt;h4&gt;Group Information&lt;/h4&gt; The ASPIRE Study Group included Dmitry Gryaznov, Belinda von Niederhäusern, Benjamin Speich, Benjamin Kasenda, Elena Ojeda-Ruiz, Anette Blümle, Stefan Schandelmaier, Dominik Mertz, Ayodele Odutayo, Yuki Tomonaga, Alain Amstutz, Christiane Pauli-Magnus, Viktoria Gloy, Szimonetta Lohner, Karin Bischoff, Katharina Wollmann, Laura Rehner, Joerg J. Meerpohl, Alain Nordmann, Katharina Klatte, Nilabh Ghosh, Ala Taji Heravi, Jacqueline Wong, Ngai Chow, Patrick Jiho Hong, Kimberly McCord, Sirintip Sricharoenchai, Jason W. Busse, Lukas Kübler, Pooja Gandhi, Zsuzsanna Kontar, Julia Hüllstrung, Mona Elafy, Arnav Agarwal, Ramon Saccilotto, Alexandra N. Griessbach, Christof Schönenberger, Matthias Schwenkglenks, Giusi Moffa, Lars G. Hemkens, Sally Hopewell, Erik von Elm, and Matthias Briel.
&lt;h4&gt;Additional Information&lt;/h4&gt; Matthias Briel is a co–corresponding author (matthias.briel@usb.ch).


The 10th Peer Review Congress

Nonregistration, Discontinuation, and Nonpublication of Randomized Trials in Switzerland, the UK, Germany, and Canada: An Updated Meta-Research Study

preregistration of studies

trial registration

quality of reporting

The Tenth Peer Review Congress featured 3 days for presentations of new research into peer review and all aspects of scientific publication, bias, quality of reporting, and information access and dissemination.

This year’s meeting was hybrid, and all plenary sessions were livestreamed with opportunities to view presentations and engage with participants in person and virtually during and after the meeting. All recordings are now available on Underline for viewing.

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#### Why? 
Our aim is to encourage research into the quality and credibility of peer review and scientific publication, to establish the evidence base on which scientists can improve the conduct, reporting, and dissemination of scientific research.

#### Who? 
Participants include editors and publishers of scientific peer-reviewed journals, researchers, funders, bibliometric and informatics experts, information innovators, librarians, journalists, policymakers, ethicists, scientific information disseminators, and anyone interested in the progress of the scientific information enterprise and the quality of scientific evidence.

The Congress embraces a wide range of disciplines, including biomedicine, health and life sciences, applied sciences, basic sciences, physical and chemical sciences, mathematics, computer sciences, engineering, economics, and social sciences as well as new and emerging disciplines.

#### What? 
The Congress provides a forum for the presentation and discussion of new research into the quality and credibility of editorial and funding peer review, scientific and scholarly publication, research methods and reporting practices, identification and management of biases, transparency, reproducibility, access, publication and dissemination metrics, identification and management of threats to the integrity of science, and advances in information exchange.

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The Tenth Peer Review Congress features 3 days for presentations of new research into peer review and all aspects of scientific publication, bias, quality of reporting, and information access and dissemination.

<p>Benjamin Speich,<sup>1</sup> Ala Taji Heravi,<sup>1</sup> Johannes M. Schwenke,<sup>1</sup> Christof M. Schönenberger,<sup>1</sup> Lena Hausheer,<sup>1</sup> Dmitry Gryaznov,<sup>1</sup> Jason W. Busse,<sup>2,3</sup> Manuela Covino,<sup>1</sup> Szimonetta Lohner,<sup>4</sup> Malena Chiaborelli,<sup>1</sup> Ruben<sup> </sup>Ramirez,<sup>1</sup> Ramon Saccilotto,<sup>5</sup> Erik von Elm,<sup>6</sup> Arnav Agarwal,<sup>3</sup> Julian Hirt,<sup>7</sup> David Mall,<sup>1</sup> Alain Amstutz,<sup>1</sup> Selina Epp,<sup>1</sup> Dominik Mertz,<sup>3</sup> Anette Blümle,<sup>8</sup> Belinda von Niederhäusern,<sup>9</sup> Ayodele Odutayo,<sup>10</sup> Alexandra N. Griessbach,<sup>1</sup> Sally Hopewell,<sup>11</sup> Matthias Briel,<sup>1,3</sup> for the ASPIRE Study Group</p>
<h4>Objective</h4>
<p> Previous studies found that approximately one-third of randomized clinical trials (RCTs) were discontinued prematurely and that the most common reason for stopping early was poor recruitment of participants. To minimize research waste, it is crucial that all RCTs are registered and make their results available. Hence, we aimed to (1) assess the fate of RCTs approved by ethics committees in 2016 in terms of nonregistration, discontinuation, and nonpublication and (2) examine RCT characteristics associated with discontinuation due to poor recruitment and nonpublication of RCT results.</p>
<h4>Design</h4>
<p> We had access to 347 RCT protocols that were approved in 2016 by research ethics committees in the UK, Switzerland, Germany, and Canada. Key trial characteristics were extracted from approved trial protocols. <span lang="de-DE">Trial registration was verified using registration numbers from the protocol and by searching the </span>World Health Organization<span lang="de-DE"> International Clinical Trials Registry Platform, ClinicalTrials.gov, </span>European Union Clinical Trials Register<span lang="de-DE">, ISRCTN, and Google; trials were deemed nonregistered if not found. We searched for full-text publications in PubMed, Google Scholar, and Scopus. Searches for both registration and publication used (</span>1<span lang="de-DE">) full titles</span>,<span lang="de-DE"> (</span>2<span lang="de-DE">) short titles</span>,<span lang="de-DE"> (</span>3<span lang="de-DE">) study acronyms</span>,<span lang="de-DE"> and (</span>4<span lang="de-DE">) the study population and intervention. </span>All searches were conducted in duplicate (last search, July 2024). In case the status of an RCT was unclear, we contacted the corresponding ethics committee or the principal investigator. We reported the proportion of nonregistered RCTs, discontinued RCTs (including reason for early discontinuation), and nonpublished RCTs (considering peer-reviewed publications and results in trial registries). </p>
<h4>Results</h4>
<p> Of the 347 included RCTs from 2016, 20 (5.8%) were nonregistered (industry-sponsored RCTs, 5 of 181 [2.8%]; nonindustry RCTs, 15 of 166 [9.0%]). Approximately one-third of RCTs (108 of 347 [31.1%]) were discontinued, most often due to poor recruitment (49 of 108 [45.4%]). A total of 276 of 347 RCTs (79.5%) made their results available at any source, 249 (71.8%) as a peer-reviewed publication, and 170 (49.0%) in the trial registry. Discontinued RCTs had lower result availability than completed RCTs (discontinued, 74 of 108 [68.5%]; completed, 202 of 226 [89.4%]). Results from industry-sponsored trials were more often available compared with nonindustry trials (92% vs 66%). This difference was driven by the fact that only 17 of 166 nonindustry RCTs (10.2%) reported results in trial registries compared with 153 of 181 industry trials (84.5%). The status of 4% of RCTs remained unclear despite our efforts to contact investigators.</p>
<h4>Conclusions</h4>
<p> Nonregistration, premature discontinuation due to poor recruitment, and nonpublication of RCT results remain major challenges, especially for nonindustry trials.</p>

<sup>1</sup>Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland, johannesmanteo.schwenke@usb.ch; <sup>2</sup>Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada; <sup>3</sup>Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; <sup>4</sup>MTA–PTE Lendület Momentum Evidence in Medicine Research Group, Medical School, University of Pécs, Pécs, Hungary; <sup>5</sup>Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland; <sup>6</sup>Cochrane Switzerland, Centre for Primary Care and Public Health (Unisante), University of Lausanne, Lausanne, Switzerland; <sup>7</sup>Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel and University of Basel, Basel, Switzerland; <sup>8</sup>Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; <sup>9</sup>Roche Pharma AG, Grenzach-Wyhlen, Germany; <sup>10</sup>University Health Network, Division of Nephrology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; <sup>11</sup>Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
<h4>Conflict of Interest Disclosures</h4> Benjamin Speich and Matthias Briel received unrestricted grants from Moderna for the conduct of the COVERALL-2 and COVERALL-3 study. Benjamin Speich has received honoraria from Moderna and Roche for presenting study results not related to this work. Johannes M. Schwenke is paid by the Swiss National Science Foundation for work unrelated to this project. No other disclosures were reported.
<h4>Funding/Support</h4> The study is supported by the Swiss Federal Office of Public Health (Matthias Briel).
<h4>Role of the Funder/Sponsor</h4> The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the abstract; and decision to submit the abstract for presentation.
<h4>Group Information</h4> The ASPIRE Study Group included Dmitry Gryaznov, Belinda von Niederhäusern, Benjamin Speich, Benjamin Kasenda, Elena Ojeda-Ruiz, Anette Blümle, Stefan Schandelmaier, Dominik Mertz, Ayodele Odutayo, Yuki Tomonaga, Alain Amstutz, Christiane Pauli-Magnus, Viktoria Gloy, Szimonetta Lohner, Karin Bischoff, Katharina Wollmann, Laura Rehner, Joerg J. Meerpohl, Alain Nordmann, Katharina Klatte, Nilabh Ghosh, Ala Taji Heravi, Jacqueline Wong, Ngai Chow, Patrick Jiho Hong, Kimberly McCord, Sirintip Sricharoenchai, Jason W. Busse, Lukas Kübler, Pooja Gandhi, Zsuzsanna Kontar, Julia Hüllstrung, Mona Elafy, Arnav Agarwal, Ramon Saccilotto, Alexandra N. Griessbach, Christof Schönenberger, Matthias Schwenkglenks, Giusi Moffa, Lars G. Hemkens, Sally Hopewell, Erik von Elm, and Matthias Briel.
<h4>Additional Information</h4> Matthias Briel is a co–corresponding author (matthias.briel@usb.ch).


technical paper

<p>Ana Marušić<sup>1</sup></p>
<h4>Importance </h4>
<p>Authorship is the currency of academia and research, but it is not only about recognition. It brings accountability and transparency and can have ethical and legal implications.</p>
<h4>Observations </h4>
<p>Starting from the call for contributors to replace authors by Drummond Rennie and his colleagues almost 30 years ago,<sup>1</sup> the evolution of scientific authorship and contributorship models will be presented. Current challenges to authorship will also be explored, from paper mills to artificial intelligence.</p>
<h4>Conclusions </h4>
<p>Authorship has not been replaced by contributorship and will need a systemic approach to balance scientific credit, career advancement, and ethical responsibility.</p>
<h4>Reference</h4>
<p>1. Rennie D, Yank V, Emanuel L. When authorship fails: a proposal to make contributors accountable. <i>JAMA</i>. 1997;278(7):579-585. doi:10.1001/jama.278.7.579</p>

<p><sup>1</sup>University of Split School of Medicine, Split, Croatia; ana.marusic@mefst.hr.</p>
<h4>Conflict of Interest Disclosures</h4> Ana Marušić is a member of the Peer Review Congress Advisory Board but was not involved in the review or decision for this abstract.


Forward to the Past - Making Contributors Accountable

<p>David Blanco,<sup>1</sup> Elizabeth Loder,<sup>2,3</sup> Sophie Cook,<sup>3</sup> Martí Casals,<sup>4,5</sup> Jordi Cortés,<sup>6</sup><span lang="ar-SA"> Aïda Cadellans-Arroniz,</span><sup>1</sup> Victor Zárate,<sup>1</sup> Ella Hubbard,<sup>3</sup> Sara Schroter<sup>3,7</sup></p>
<h4>Objective </h4>
<p>In 2005, the International Committee of Medical Journal Editors (ICMJE) mandated that all clinical trials be properly registered—that is, registered in an approved registry at or before the enrollment of the first participant.<sup>1</sup> Despite improved registration rates, many trials published in journals claiming adherence to ICMJE registration policy remain improperly registered.<sup>2</sup> This study aimed to (1) identify variables associated with improper registration; (2) examine types of registration deficiencies, publication status, and disclosure of registration issues in improperly registered trials; and (3) assess authors’ claims of proper registration.</p>
<h4>Design </h4>
<p>This observational study analyzed 239 improperly and 239 properly registered trials submitted to <i>The BMJ</i> (2019-2023). For objective 1, we collected data on trial design, setting, sample size, intervention type, number of authors, corresponding author region, mention of Consolidated Standards of Reporting Trials (CONSORT) guidelines, submission year, and funding source. For objective 2, we examined improperly registered trials submitted between 2019 and 2021, focusing on registration deficiency type (retrospective registration in approved registry, registration in unapproved registry, or no registration), registration delay (for retrospectively registered trials), and publication status. For published trials, we recorded Journal Impact Factor, ICMJE affiliation, time to publication, and disclosure of registration issues. For objective 3, we assessed authors’ claims of prospective registration for improperly registered trials. Analyses included multivariable logistic regression and descriptive statistics.</p>
<h4>Results </h4>
<p>Several variables were associated with reduced odds of improper registration: larger sample size (101-500 vs 1-100; odds ratio [OR], 0.43 [95% CI, 0.22-0.84]), corresponding authors from Oceania (reference: Europe; OR, 0.35 [95% CI, 0.14-0.82]), more authors (10 vs 1; OR, 0.53 [95% CI, 0.32-0.87]), CONSORT mention (OR, 0.22 [95% CI, 0.06-0.67]), recent submissions (2021-2023 vs 2019-2020; OR, 0.63 [95% CI, 0.42-0.96]), and funding (eg, nonprofit vs no funding; OR, 0.20 [95% CI, 0.09-0.41]). Trials with authors from Asia (OR, 1.75 [95% CI, 1.07-2.89]) had higher odds of improper registration. Of 176 improperly registered trials, 82.4% (n = 145) were retrospectively registered in approved registries (median delay, 6.54 months; Q1, 2.50 months; Q3, 18.67 months), 13.1% (n = 23) were unregistered, and 4.5% (n = 8) used unapproved registries. Most (88.1% [n = 155 trials]) were later published, including 1 in <i>The BMJ</i>. Among these, 89.0% (n = 138) appeared in journals with an Impact Factor (median, 5.39; Q1, 3.98; Q3, 10.40) and 62.0% (n = 96) in journals claiming adherence with ICMJE registration policy. Median time to publication was 12 months (Q1, 8 months; Q3, 19 months). Only about one-sixth explicitly acknowledged the registration issue at the time of publication. Of 72 responses to <i>The BMJ</i>’s submission question on prospective registration (2021-2023), 83.3% (n = 60) incorrectly claimed compliance.</p>
<h4>Conclusions </h4>
<p>We identified variables associated with improper trial registration. Retrospective registration was common, and most improperly registered trials rejected by <i>The BMJ</i> were later published in other ICMJE-affiliated journals. ICMJE journals should strengthen processes to better identify and reject improperly registered trials.</p>
<h4>References</h4>
<p>1. International Committee of Medical Journal Editors. Clinical trials. Accessed January 23, 2025. <a href="https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html">https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html</a></p>
<p>2. Trinquart L, Dunn AG, Bourgeois FT. Registration of published randomized trials: a systematic review and meta-analysis. <i>BMC Med</i>. 2018;16(1):173. doi:10.1186/s12916-018-1168-6</p>

<sup>1</sup>Department of Physiotherapy, Universitat Internacional de Catalunya, Barcelona, Spain, dblanco@uic.es; <sup>2</sup>Department of Neurology, Brigham and Women’s Hospital, Boston, MA, US; <sup>3</sup>The BMJ, London, UK; <sup>4</sup>National Institute of Physical Education of Catalonia, University of Barcelona, Barcelona, Spain; <sup>5</sup>Sport and Physical Activity Studies Centre, Faculty of Medicine, University of Vic - Central University of Catalonia, Barcelona, Spain; <sup>6</sup>Biostatistics and Bioinformatics Research Group, Department of Statistics and Operations Research and Institute for Research and Innovation in Health, Universitat Politècnica de Catalunya, Barcelona, Spain; <sup>7</sup>Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.
<h4>Conflict of Interest Disclosures</h4> Sophie Cook and Sara Schroter are full-time employees of the BMJ Group and Elizabeth Loder is a part-time employee.


Factors Associated With Improper Clinical Trial Registration, Registration Deficiencies, and Publication Status of Submissions to the BMJ

<p>Eun Hye Lee,<sup>1,2,3,4</sup> San Lee,<sup>1,3,5</sup> Jae Il Shin,<sup>3,4,6</sup> John P. A. Ioannidis<sup>1,7,8,9</sup></p>
<h4>Objective</h4>
<p> East Asia has become a major hub for clinical trials.<sup>1</sup> Although a few studies have compared ClinicalTrials.gov with local registries in specific disease domains, comprehensive comparisons remain limited.<sup>2</sup> This study analyzes registered clinical trial trends in East Asia during 2014 to 2025 and compares them with trends in the US.</p>
<h4>Design</h4>
<p> We extracted clinical trial data through the World Health Organization–operated International Clinical Trials Registry Platform (ICTRP), which integrates ClinicalTrials.gov and local registries. Because Taiwan’s registry is not part of the ICTRP, we collected its data separately. We analyzed overall clinical trial trends and filtered randomized clinical trials (RCTs), categorizing them by location, target size, and disease category. Trials conducted in only 1 country were categorized as domestic, whereas those conducted in 2 or more countries were classified as international. We explored the proportion of studies registered prospectively, defined as within 1 month of the trial start date.<sup>3</sup></p>
<h4>Results</h4>
<p> China experienced rapid growth in clinical trials, surpassing both Japan and the US in total trials and RCTs (<b>Figure 25-1020</b>). In China, the number of registered trials increased markedly from 2578 total trials (1521 RCTs) in 2014 to 16,612 (7798 RCTs) in 2023. In contrast, the US showed a more modest increase from 8841 trials (4056 RCTs) in 2014 to 9100 (4619 RCTs) in 2023. Except for China, all other countries experienced a postpandemic decline, with annual trial registrations decreasing by approximately 3% to 10% in recent years.<span class="CharOverride-18"> </span>Neoplastic diseases and cardiovascular and metabolic diseases accounted for the largest percentages, each representing approximately 15% to 25% of all registered trials. In the US, mental health trials increased from 11.9% in 2014 to 16.0% in 2023, reflecting growing interest in this area. In 2023, China’s RCTs were predominantly domestic, with international trials making up only 1.8% (140) of the total, while 13.1% (603) of RCTs in the US were international. Domestic RCTs were predominantly small-sized trials (&lt;100 participants), while international RCTs were more commonly medium-sized (100-499 participants) or large-sized (≥500 participants) trials. In 2023, 75% of China’s RCTs (5841 of 7798) and 81% of Japan’s RCTs (1081 of 1339) were domestic trials registered in local registries, highlighting the predominant use of local registries in both countries. Although the trend has increased over the past decade, a considerable percentage of RCTs, ranging from 15% to 35% across countries, were still not registered prospectively in 2023. We recorded some inconsistencies and missing information across existing registries. Updated data to mid-2025 will be presented at the congress.</p>

![](https://assets.underline.io/markdown_image/1/image/f1904b3cba2f1d83b5fb2807bec4e17d.png)

<h4>Conclusions</h4>
<p> The study highlights the increasing prominence of East Asia, particularly China, in registered clinical trials, though with a primarily domestic focus. Improvements in existing trial registries covering East Asia are desirable.</p>
<h4>References</h4>
<p>1. Ali S, Egunsola O, Babar ZUD, Hasan SS. Clinical trials in Asia: a World Health Organization database study. <i>Perspect Clin Res.</i> 2019;10(3):121-124. doi:10.4103/picr.PICR_109_18</p>
<p>2. Doi M, Yukawa K, Sato H. Characteristics of Asian 4 countries on cancer clinical trials registered in the international clinical trials registry platform between 2005 and 2018. <i>Chin Clin Oncol</i>. 2021;10(3):28. doi:10.21037/cco-21-17</p>
<p>3. Klatte K, Sluka c, Gloy V, et al. Towards full clinical trial registration and results publication: longitudinal meta-research study in Northwestern and Central Switzerland. <i>BMC Med Res Methodol</i>. 2023;23(1):27. doi:10.1186/s12874-023-01840-9</p>

<sup>1</sup>Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, US, jioannid@stanford.edu; <sup>2</sup>Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin-si, Gyeonggi-do, South Korea; <sup>3</sup>The Center for Medical Education Training and Professional Development, Yonsei Donggok Medical Education Institute, Seoul, Korea; <sup>4</sup>Severance Underwood Meta-Research Center, Institute of Convergence Science, Yonsei University, Seoul, South Korea; <sup>5</sup>Department of Psychiatry and the Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, South Korea; <sup>6</sup>Department of Pediatrics, Yonsei University College of Medicine, Seoul, South Korea; <sup>7</sup>Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA, US; <sup>8</sup>Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, US; <sup>9</sup>Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, CA, US.
<h4>Conflict of Interest Disclosures</h4> John P. A. Ioannidis is a member of the Peer Review Congress Advisory Board but was not involved in the review or decision for this abstract.
<h4>Funding/Support</h4> The work of John P. A. Ioannidis is supported by an unrestricted gift from Sue and Bob O’Donnell to Stanford University.
<h4>Role of the Funder/Sponsor</h4> The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
<h4>Additional Information</h4> A language model based on Bidirectional Encoder Representations from Transformers (BERT) was employed on December 30, 2024, to classify disease categories in RCTs. Specifically, PubMedBERT, a version pretrained on biomedical literature from PubMed, was used to automate the disease classification of clinical trials. San Lee takes responsibility for the integrity of the content. Eun Hye Lee and San Lee contributed equally to this study.


Registered Clinical Trial Trends in East Asia and the United States, 2014 to 2025

<p>Aidan Christopher Tan,<sup>1,2</sup> Yiyi Lin,<sup>1</sup> Michellie Lian,<sup>1</sup> Zhilin Ren,<sup>1</sup> Tony Lian,<sup>1</sup> Vincent Yuan,<sup>3</sup> Angela Webster,<sup>1</sup> Anna Lene Seidler<sup>1</sup></p>
<h4>Objective</h4>
<p> We aimed to describe researcher adherence to journal data sharing policies across health research. This included describing what factors increase intention to share data and how journal policies requiring data sharing impact intended data sharing.</p>
<h4>Design</h4>
<p> This was a cross-sectional study of all original research published in the highest-impact medical journals in 2022. Journals were included if they ranked among the top 5 in Impact Factor in 59 fields of medicine in the 2020 Journal Citation Reports, had a data sharing policy that either required or recommended sharing data, and published original research. Journal websites were searched to identify all original research published in 2022. Data were manually collected on study characteristics (study type, industry involvement, and COVID-19 relevance) and data sharing plans (data sharing statements and data sharing intentions extracted from publicly available research protocols and articles). Articles were descriptively analyzed by these journal data sharing policies, study characteristics, and data sharing plans.</p>
<h4>Results</h4>
<p> Of 134 journals included, 36 (27%) required data sharing and 98 (73%) recommended data sharing. The analysis included 1868 interventional studies (1383 randomized clinical trials [74%] and 485 nonrandomized trials [26%]) and 10,368 observational studies (4814 cohort studies [46%], 4166 cross-sectional studies [40%], 1100 case-control studies [11%], and 288 case series/reports [3%]). Publicly available research protocols were available for 1993 of 10,243 studies (16%), of which 1153 (58%) had an initial data sharing statement. Only 1023 interventional studies (55%) and 4511 observational studies (44%) in journals that recommended or required data sharing actually intended to share data. Most studies only intended to share data underlying the published results with researchers, for purposes and by mechanisms at the discretion of and subject to approval by the principal investigator and without supporting documents or specified timeframes. Factors associated with increased intention to share data included journal policies that required data sharing and data sharing statements as well as industry involvement and COVID-19 relevance for interventional studies. For journals with policies that required data sharing, researchers were more likely to share more data (ie, all data collected during the study) and supporting documents (ie, supporting documents) in a timelier manner (ie, immediately following publication and indefinitely) to more people (ie, to anyone who wishes to access the data) for more purposes (ie, for any purpose) and by easier means (ie, with unrestricted access through a third-party website).</p>
<h4>Conclusions</h4>
<p> Journals that required data sharing had higher rates of studies that intended to share data compared with journals that only recommended data sharing. However, most studies that intended to share data had restrictions on sharing. In addition to requiring data sharing and data sharing statements, journals should define and explain data sharing and individual participant data, better review data sharing statements and the reasonableness of justifications to not share data, and provide additional guidance on the operationalization of data sharing in accordance with best practice.</p>

<sup>1</sup>NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia, aidan.tan@sydney.edu.au; <sup>2</sup>Sydney School of Public Health, University of Sydney, Sydney, Australia, <sup>3</sup>University of New South Wales, Sydney, Australia.
<h4>Conflict of Interest Disclosures</h4> None reported.
<h4>Funding/Support</h4> This work was supported by a research contract from CT:QI.
<h4>Role of the Funder/Sponsor</h4> CT:QI had no role in the study design, conduct, analysis, or reporting.


Researcher Adherence to Journal Data Sharing Policies: A Meta-Research Study

<p>Robert Thibault,<sup>1,2</sup> Dana E. Cobb-Lewis,<sup>1,2</sup> Matt Lewis,<sup>1,2</sup> Devin Snyder,<sup>1,2</sup> Cornelis Blauwendraat,<sup>1,2</sup> Sonya Dumanis<sup>1,2</sup></p>
<h4>Objective </h4>
<p>We examined whether a funder-led open science policy and compliance workflow could increase the deposition and unambiguous identification of research data, code, protocols, and key laboratory materials (eg, cell lines, antibodies).</p>
<h4>Design </h4>
<p>A cross-sectional study was conducted on articles supported by the Aligning Science Across Parkinson’s (ASAP) Collaborative Research Network (CRN) and published between January 1, 2024, and April 30, 2025 (N = 102). The study was exploratory, and thus was not registered, and does not present inferential statistics. ASAP has a thorough Open Science Policy<sup>1</sup> and Compliance Workflow,<sup>2</sup> which require grantees to send manuscript drafts to ASAP staff, post preprints, deposit research outputs, and unambiguously identify research inputs. The workflow is managed by an ASAP staff member who integrates automated and manual assessments to provide a grantee with systematic feedback outlining the actions required to align their manuscript draft with the ASAP Open Science Policy.</p>
<h4>Results </h4>
<p>Between the version of a manuscript first shared with ASAP staff and the associated final publication, there were substantial increases in the deposition of newly generated datasets (21% for the first version to 88% for the published version), unambiguous identification of reused datasets (72% to 86%), deposition of newly generated code (15% to 72%), unambiguous identification of software used (35% to 79%), registration of newly generated key lab materials (22% to 78%), unambiguous identification of key lab materials used (44% to 87%), and deposition of newly generated protocols and unambiguous identification of existing protocols (35% to 81%; data on protocols was collapsed) (<b>Table 25-0892</b>). Of the included publications, 98% (100 of 102) had an associated preprint. Preprints were posted a median (IQR) of 4 (−7 to 50) days before submission to the journal in which they were eventually published and 236 (150-328) days before they were published in a journal. To facilitate this workflow, grantees share each manuscript alongside a Key Resource Table that lists persistent identifiers for the associated datasets, code, software, protocols, and key lab materials. Collating these Key Resource Tables provides a living and near-comprehensive log of all the inputs and outputs from ASAP CRN–funded research.</p>

![](https://assets.underline.io/markdown_image/1/image/42436f84ba0deebd5496f77519d9878a.png)

<h4>Conclusions </h4>
<p>A funder-led intervention to monitor and support a robust open science policy can foster the posting of preprints and the sharing of data, code, protocols, and key lab materials.</p>
<h4>References</h4>
<p>1. Thibault R. ASAP Open Science Policy Handbook. Zenodo. 2024. doi:10.5281/zenodo.13769766</p>
<p>2. Cobb-Lewis DE, Snyder D, Dumanis S, et al. Investing in open science: key considerations for funders. <i>bioRxiv</i>. 2024:12.09.627554. doi:10.1101/2024.12.09.627554</p>

<sup>1</sup>Aligning Science Across Parkinson’s (ASAP), Chevy Chase, MD, US, openscience@parkinsonsroadmap.org; <sup>2</sup>Coalition for Aligning Science (CAS), Chevy Chase, MD, US.
<h4>Conflict of Interest Disclosures</h4> All authors are employees or contractors of CAS, the managing organization for ASAP.
<h4>Funding/Support</h4> The authors conducted this research as part of their employment or contract with CAS. No additional funding was sought or acquired to conduct this research.
<h4>Acknowledgment</h4> We thank the Michael J. Fox Foundation for Parkinson’s Research for their partnership in implementing the ASAP research initiative and for their assistance with the Open Science Compliance Workflow. We thank DataSeer for their active part in the development and conduct of the ASAP Open Science Compliance Workflow.
<h4>Additional Information</h4> The authors’ ORCIDs are as follows: Robert Thibault, https://orcid.org/0000-0002-6561-3962; Dana E. Cobb-Lewis, https://orcid.org/0000-0002-4104-0311; Matt Lewis, https://orcid.org/0000-0002-9091-5516; Devin Snyder, https://orcid.org/0000-0001-8528-7538; Cornelis Blauwendraat, https://orcid.org/0000-0001-9358-8111; Sonya Dumanis, https://orcid.org/0000-0002-3345-9497. ChatGPT-4o (OpenAI) was used between February 10, 2025, and June 10, 2025, to help write the R Markdown script used to analyze the data. Robert Thibault takes responsibility for the integrity of the content generated. Data, codebooks, code, results, and instructions for how to reproduce our results are available on GitHub at https://github.com/robert-thibault/peer-review-congress-abstract and have been assigned a persistent identifier via Zenodo at https://doi.org/10.5281/zenodo.15832432. The ASAP Open Science Policy is available at https://doi.org/10.5281/zenodo.13769765. A preprint detailing the ASAP Open Science Compliance Workflow is available at https://doi.org/10.1101/2024.12.09.627554.


A Funder-Led Intervention to Increase the Sharing of Data, Code, Protocols, and Key Laboratory Materials

<p>Kyobin Hwang,<sup>1</sup> Zexing Song,<sup>2,3</sup> Marsida Stafa,<sup>3</sup> Jodie Chiu<sup>,4</sup><sup> </sup>An-Wen Chan<sup>1,3,5</sup></p>
<p><h4>Objective</h4> We aimed to determine how often medical journals have policies requiring clinical trial registration, adherence to reporting guidelines, and participant-level data sharing. We also evaluated associations between journal characteristics and the existence of such policies for clinical trial manuscripts.</p>
<p><h4>Design </h4>A PubMed search using the clinical trial filter was conducted to identify journals that published at least 20 trials in 2023. We extracted publicly available data from journal websites, including policies on trial registration, adherence to reporting guidelines, trial protocol submission requirements, and availability of participant-level data. A practice was classified as required if the policy used words such as must, need, or should. Policies using language such as encouraged and preferred were classified as recommended practices. For each journal, we recorded the 2023 Clarivate impact factor, journal scope (general vs specialty), and publishing model (purely open access vs other). We calculated descriptive statistics to summarize the prevalence of transparency policies and used multivariable logistic regression to assess the association between journal characteristics and policy requirements.</p>
<h4>Results</h4>
<p> Among 380 included journals, 320 (84%) required trial registration, 11 (3%) recommended it, and 49 (13%) did not mention it. Adherence to a reporting guideline for clinical trials was required by 251 journals (66%), recommended by 74 (19%), and not mentioned by 55 (14%). Trial protocol submission was required by 118 (31%), recommended by 110 (29%), and not mentioned in 152 (40%). Public availability of participant-level datasets was required by 104 (27%), recommended by 218 (57%), and not mentioned by 58 (15%). A description of the data sharing plan was required by 212 journals (55.8%), recommended by 110 (28.9%), and not mentioned by 58 (15.3%). Purely open access journals had a 4-fold higher odds of requiring trial registration (adjusted odds ratio [AOR], 4.02; 95% CI, 1.41-15.59) and protocol submission (AOR, 4.13; 95% CI, 2.17-8.37) and 2.5 times higher odds of requiring public sharing of participant-level data (AOR, 2.46; 95% CI, 1.03-7.04) compared with other journals (<b>Table 25-1183</b>). Each 5-point increase in journal impact factor was associated with a more than 2.5-fold increase in the odds of requiring trial registration (AOR, 2.65; 95% CI, 1.45-5.98) and over 50% increase in the odds of requiring protocol submission (AOR, 1.56; 95% CI, 1.26-2.03). Impact factor was not significantly associated with requiring data sharing. No significant associations were found for journal scope or volume of trials published.</p>

![](https://assets.underline.io/markdown_image/1/image/1f3e3ae7eedf2cd146453708cac3c6fc.png)

<h4>Conclusions</h4>
<p> Journal policy requirements vary substantially in supporting best practices for clinical trial transparency. Journals with a purely open access publishing model and higher impact factor were more likely to adopt transparency policies. These findings highlight the need for improved editorial standards across the publishing landscape to promote transparency and reduce research waste.</p>

<sup>1</sup>Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada, anwen.chan@utoronto.ca; <sup>2</sup>Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; <sup>3</sup>Women’s College Research Institute, Toronto, Ontario, Canada; <sup>4</sup>Faculty of Health Science, University of Western Ontario, London, Ontario, Canada; <sup>5</sup>Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
<h4>Conflict of Interest Disclosures</h4> An-Wen Chan is a member of the Peer Review Congress Advisory Board but was not involved in the review or decision for this abstract.


Medical Journal Policies on Requirements for Clinical Trial Registration, Reporting Guidelines, and Data Sharing: A Systematic Review

<p>M. Janina Sarol,<sup>1</sup> Jodi Schneider,<sup>1,2</sup> Halil Kilicoglu<sup>1</sup></p>
<h4>Objective </h4>
<p>An estimated 25% of citations in medical journals are inaccurate.<sup>1</sup> If not corrected, these citation quotation errors can propagate misinformation and establish unfounded claims.<sup>2</sup> Correcting them before publication is vital, yet citation accuracy is overlooked in the peer review process. The prevalence of citation quotation errors in the biomedical literature also remains unclear, because existing studies rely on manual evaluation on a limited set of articles.</p>
<h4>Design </h4>
<p>We explored the use of large language models, specifically Gemini 1.5 Pro, GPT-4o (gpt-4o-2024-08-06), and LLaMA-3.1 (8B and 70B), to automatically identify citation quotation errors. We compared 2 approaches. In the first, we supplied the prompt with the citation in question, the paragraph containing the citation, and the full reference article. The second approach consists of a 3-step procedure and mimicked how a human reviewer might perform the task manually by first identifying the citation context, then locating relevant sentences in the reference article, and finally assessing citation accuracy. Specifically, the procedure consists of (1) extracting the citation sentence, (2) retrieving the 50 most relevant sentences using the MedCPT retriever model and reranking them with a fine-tuned MonoT5 model to select the top 5 sentences, and (3) verifying the citation accuracy with the large language model (<b>Box 25-1015</b>). Both approaches were evaluated from November 2024 to January 2025 using a citation quotation error dataset,<sup>3</sup> the first publicly available corpus of its kind (Cohen κ for interrater agreement: 0.96 for citation context and 0.31 for accuracy detection). The better-performing approach was applied to assess 2898 citations from 2000 articles to the 100 most cited PubMed Central Open Access (PMC-OA) articles (24 different journals).</p>

![](https://assets.underline.io/markdown_image/1/image/d650d5b842c02ea3ae5d4d9c28d01a15.png)

![](https://assets.underline.io/markdown_image/1/image/e80718c94a9aa238f09a1d74fc02135d.png)

<h4>Results </h4>
<p>Gemini 1.5 Pro yielded best performance, obtaining an accuracy of 69% with both approaches. It outperformed GPT-4o slightly, while LLaMA-3 failed to generate meaningful results with the first approach and performed poorly with the second. Because the first approach only identified 25% (55 of 220) of the erroneous citations and the 3-step procedure identified 51% (113 of 220), the second approach was applied to the subset of PMC-OA articles. In the PMC-OA subset, 34% (981 of 2898) of the citation instances were assessed as erroneous. A total of 37% (742 of 2000) of citing articles were found to contain citation quotation errors; 98% (98 of 100) of reference articles were cited incorrectly at least once.</p>
<h4>Conclusions </h4>
<p>Our preliminary results confirm the high prevalence of citation quotation errors in the medical literature. We will present a more comprehensive analysis of citation quotation errors in the PMC-OA subset at the conference. Automated verification of citations could help journals and peer reviewers identify questionable citation practices and reduce propagation of misinformation, improving the trustworthiness of scientific evidence.</p>
<h4>References</h4>
<p>1. Jergas H, Baethge C. Quotation accuracy in medical journal articles: a systematic review and meta-analysis. <i>PeerJ</i>. 2015;3:e1364. doi:10.7717/peerj.1364</p>
<p>2. Greenberg SA. How citation distortions create unfounded authority: analysis of a citation network. <i>BMJ</i>. 2009;339:b2680. doi:10.1136/bmj.b2680</p>
<p>3. Sarol MJ, Ming S, Radhakrishna S, Schneider J, Kilicoglu H. Assessing citation integrity in biomedical publications: corpus annotation and NLP models. <i>Bioinformatics</i>. 2024;40(7):btae420. doi:10.1093/bioinformatics/btae420</p>

<sup>1</sup>University of Illinois at Urbana-Champaign, IL, US, janinasarol@gmail.com; <sup>2</sup>Harvard Radcliffe Institute for Advanced Study, Cambridge, MA, US.
<h4>Conflict of Interest</h4> Disclosures Jodi Schneider declares nonfinancial associations with Crossref; Committee on Publication Ethics; International Association of Scientific, Technical and Medical Publishers; the European Association of Science Editors; the International Society of Managing and Technical Editors; the Institute of Electrical and Electronics Engineers; the National Information Standards Organization; and the Center for Scientific Integrity (parent organization of Retraction Watch) and has received data-in-kind from Retraction Watch and Scite and usability testing compensation from the Institute of Electrical and Electronics Engineers. The National Information Standards Organization is a subawardee on her Alfred P. Sloan Foundation grant (G-2022-19409). No other disclosures were reported.
<h4>Funding/Support</h4> This study was supported by the Office of Research Integrity (ORI) of the US Department of Health and Human Services (HHS) (ORIIR220073). The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, the ORI, Office of the Assistant Secretary of Health, HHS, or the US government. Jodi Schneider was supported in part as the 2024-2025 Perrin Moorhead Grayson and Bruns Grayson Fellow, Harvard Radcliffe Institute for Advanced Study and by US National Science Foundation’s CAREER grant (2046454).
<h4>Role of the Funder/Sponsor</h4> The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication.
<h4>Acknowledgment</h4> We thank Shruthan Radhakrishna for his contributions to fine-tuning the MonoT5 model.
<h4>Additional Information</h4> Halil Kilicoglu is a co–corresponding author (halil@illinois.edu).




Leveraging Large Language Models for Detecting Citation Quotation Errors in Biomedical Literature

<p>Bojan Batalo,<sup>1</sup> Erica K. Shimomoto,<sup>1</sup> Neil Millar<sup>2</sup></p>
<h4>Objective </h4>
<p>Promotional language (hype) in biomedical research writing has increased significantly over the past 40 years and has potential to influence readers’ perceptions and evaluations of evidence.<sup>1-3</sup> Automatic systems capable of detecting and providing feedback on hype may offer a means to foster more objective reporting. However, the absence of formal guidelines for identifying hype represents a barrier for human annotators and the development of such systems. This pilot study develops formal guidelines for classifying hype and evaluates the application of annotated data to automate hype detection via machine learning.</p>
<h4>Design </h4>
<p>Annotation guidelines were developed to classify 11 adjectives commonly associated with novelty and potential hype (eg, <i>creative</i>, <i>first</i>, <i>groundbreaking</i>, <i>innovative</i>). Guidelines followed the following hierarchical decisions: (1) does the adjective imply a positive value judgment?; (2) is it hyperbolic?; (3) is the adjective gratuitous (ie, adds little to the content), amplified (strengthened by modifiers), or coordinated (paired with other promotional adjectives)?; and (4) is the broader sentential context promotional? A total of 550 sentences containing the adjectives (50 per adjective) were randomly sampled from National Institutes of Health grant abstracts funded between 2016 and 2020 and independently annotated by a linguist and 2 computer scientists, with disagreements resolved through discussion, providing the criterion standard. Our choice of grant abstracts as the starting point for our research is due to the highly competitive nature of research funding.<sup>1</sup> The annotated data were split 80:20 into development and hold-out test sets; machine learning algorithms were trained on the development and evaluated on the test set. Additionally, a human baseline was established by an additional researcher blinded to the annotation guidelines but supplied with a broad definition of hype, manually classifying the test set. Experiments tested 4 traditional text classification methods (multinomial Naive Bayes, multivariate Bernoulli Naive Bayes, latent semantic analysis, and support vector machines), with bag-of-words and averaged global vectors for word representation (GloVe) word embeddings as input features (<b>Table 25-0929</b>). Performance was evaluated using accuracy, weighted precision, recall, and F1 scores.</p>

![](https://assets.underline.io/markdown_image/1/image/334927ffdad7b95527ef7831f37feb90.png)

<h4>Results </h4>
<p>Excluding 13 sentences due to nonadherence with the guidelines, the final sample comprised 537 reliably annotated sentences (Cohen κ &gt; 0.94), of which 392 were classified as hype. Among machine learning models, GloVe-based support vector machines outperformed others with an accuracy of 79.6%, approximating the human baseline of 82.4%.</p>
<h4>Conclusions </h4>
<p>The annotation process underscored the subjective nature of assessing promotional language, particularly for context-dependent adjectives like <i>emerging</i> and <i>latest</i>, and the need for refined constructs to capture gradations of promotional language. Despite these limitations, the pilot study indicates the potential for machine learning models trained on well-annotated datasets to contribute to the automated detection of hype. Future steps include modifying the annotation systems and experimenting with large language models under zero/few-shot regimes.</p>
<h4>References</h4>
<p>1. Millar N, Batalo B, Budgell B. Trends in the use of promotional language (hype) in abstracts of successful National Institutes of Health Grant Applications, 1985-2020. <i>JAMA Netw Open</i>. 2022;5(8):e2228676. doi:10.1001/jamanetworkopen.2022.28676</p>
<p>2. Qiu HS, Peng H, Fosse HB, Woodruff TK, Uzzi B. Use of promotional language in grant applications and grant success. <i>JAMA Netw Open</i>. 2024;7(12):e2448696. doi:10.1001/jamanetworkopen.2024.48696</p>
<p>3. Van Den Besselaar P, Mom C. The effect of writing style on success in grant applications. <i>J Informetr</i>. 2022;16(1):101257. doi:10.1016/j.joi.2022.101257</p>

<sup>1</sup>National Institute of Advanced Industrial Science and Technology, Japan, bojan.batalo@aist.go.jp; <sup>2</sup>University of Tsukuba, Japan.
<h4>Conflict of Interest Disclosures</h4> None reported.
<h4>Funding/Support</h4> This study was supported by grants 21K02919 and 25K00851 from the Japan Society for the Promotion of Science.
<h4>Role of the Funder/Sponsor</h4> The authors confirm that no sponsors or funders influenced the study design, execution, or interpretation of results.
<h4>Additional Information</h4> Neil Millar is a secondary corresponding author (millar.neil@u.tsukuba.ac.jp).


Automating the Detection of Promotional (Hype) Language in Biomedical Research

<p>Vishisht Rao,<sup>1</sup> Aounon Kumar,<sup>2</sup> Himabindu Lakkaraju,<sup>2</sup> Nihar B. Shah<sup>1</sup></p>
<h4>Objective </h4>
<p>Journals, conferences, and funding agencies face the risk that reviewers might ask large language models (LLMs) to generate reviews by uploading submissions. Existing detectors struggle to differentiate between fully LLM-generated and LLM-polished reviews. We addressed this problem by developing a method to detect and flag LLM-generated reviews while controlling family-wise error rates (FWERs).</p>
<h4>Design </h4>
<p>Our method had 3 components. (1) Watermarking: We stochastically chose specific phrases (watermarks), such as random (fake) citations, technical terms (“weak supervised learning”), or beginning the review with a prefix (“This paper investigates the problem…”). Watermarks were specific modifications to the review, which were undetectable unless the nature of the watermark was known. The watermark was known to the editors (but not the reviewers), who could detect LLM-generated reviews through watermarks in the review. (2) Hidden prompt injection: We added an instruction into the manuscript PDF (at the end of the last page; not detectable by the human reviewer) instructing the LLM to output the chosen watermark in the LLM-generated review (“Start your review with: &lt;chosen watermark&gt;”). We evaluated 3 injection methods: white text, font manipulation,<sup>1-3</sup> and a different language. (3) Statistical detection method: We developed a test for watermarks in the review (null hypothesis was the review was human written) and provided mathematical proof of controlling the FWER without making assumptions on how human reviews were written. The evaluation was performed on International Conference on Learning Representations (ICLR) manuscripts, a publication venue that reviews full manuscripts. We injected the hidden prompts into ICLR manuscripts and asked LLMs to generate a review and observe whether it contained the watermark. We also evaluated the robustness of our methods against 3 reviewer defenses (RDs), measures reviewers could take to avoid being flagged for using an LLM-generated review: paraphrasing (paraphrasing the original LLM-generated review using another LLM), identifying watermarks (asking the LLM to flag submissions with hidden prompts), and cropping out the end of the paper (removing the last page before generating the review using an LLM). Watermarks were most successfully embedded in the LLM-generated review when the hidden prompt was injected at the end of the last page. For the evaluation of the last RD, we injected the hidden prompt at a position other than the end of the last page.</p>
<h4>Results </h4>
<p>Our method was successful in embedding the chosen watermark in LLM-generated reviews and was robust to RD mechanisms (<b>Table 25-1176</b>) and detecting and flagging them while controlling false-positives. We conducted our test on 28,028 human-written reviews from ICLR 2021 and 10,022 from 2024, each augmented with 100 LLM-generated reviews with a watermark embedded for each of the 3 types. When executing our algorithm to control the FWER at 0.01 for the random start and technical term watermark and 0.001 for the random citation watermark, we observed 0 false-positives in all cases.</p>

![](https://assets.underline.io/markdown_image/1/image/807c4c34ebba96be96a927580c5eec72.png)

![](https://assets.underline.io/markdown_image/1/image/6a9302767961f7d9b0889e6a3b9a9a09.png)

<h4>Conclusions </h4>
<p>We propose a novel method to detect LLM-generated peer reviews. Our evaluations found this method to be successful, making it appealing to journal, conference, and proposal review organizers.</p>
<h4>References</h4>
<p>1. Markwood I, Shen D, Liu Y, Lu Z. Mirage: content masking attack against {information-based} online services. In: <i>26th USENIX Security Symposium</i>. 2017:833-847.</p>
<p>2. Tran D, Jaiswal C. PDFPhantom: exploiting PDF attacks against academic conferences’ paper submission process with counterattack. In: <i>2019 IEEE 10th Annual Ubiquitous Computing, Electronics &amp; Mobile Communication Conference</i>. October 2019:0736-0743.</p>
<p>3. Zou A, Wang Z, Carlini N, Nasr M, Kolter JZ, Fredrikson M. Universal and transferable adversarial attacks on aligned language models. <i>arXiv</i>. Preprint posted online July 27, 2023. doi:10.48550/arXiv:2307.15043</p>

<sup>1</sup>Carnegie Mellon University, Pittsburgh, PA, US, nihars@cs.cmu.edu; <sup>2</sup>Harvard University, Boston, MA, US.
<h4>Conflict of Interest Disclosures</h4> Nihar B. Shah is a member of the Peer Review Congress Advisory Board but was not involved in the review or decision for this abstract.
<h4>Funding/Support</h4> US National Science Foundations Awards 1942124, 2200410; ONR grant N000142212181.

<h4>Role of the Funder/Sponsor</h4> The funders played no role in the design and conduct of the experiment, data analysis, or preparation of the manuscript.
<h4>Acknowledgment</h4> We thank Danish Pruthi for very helpful discussions.


Evaluation of a Method to Detect Peer Reviews Generated by Large Language Models

Fares Alahdab,<sup>1,2,3</sup> Juan Franco,<sup>3,4</sup> Helen Macdonald,<sup>4</sup> Sara Schroter<sup>4</sup>
<h4>Objective</h4>
Peer reviewer fatigue is on the rise, as reviewers are overburdened with increasing tasks and manuscripts to review, making it challenging for journal editors to secure a sufficient number of high-quality reviews.<sup>1</sup> Despite the potential benefits of using large language models (LLMs) in editorial and peer review processes<sup>2</sup> and the potential to support reviewers with tasks, it is not yet known how good they are at peer review. Additionally, covert use of LLMs in peer review is increasingly suspected, with limited knowledge of positive or negative impact. We aim to compare the quality and comprehensiveness of peer reviews produced by 5 LLMs compared with peer reviewers for research submissions.
<h4>Design</h4>
A comparative study of peer reviews produced by LLMs (GPT4o, GPTo3, Claude 3.5, Gemini 1.5 Pro, and Gemini 2.0 Flash) compared with 2 human peer reviews for research submissions between May 2024 and June 2025. Manuscripts were uploaded to Google’s Vertex AI, a private and secure BMJ Group workspace for using LLMs; the same prompt was used for all submissions (single-shot prompting). An experienced editor performed the ratings of all LLM and human reviews using the Review Quality Instrument (RQI),<sup>3</sup> a tool for assessment of review quality comprising 8 questions, each on a 5-point Likert scale. Secondary outcomes include a comprehensiveness score, based on elements of the manuscript that the reviews focused on, and whether they were evaluative in nature. Additionally, once the first decision has been made on the manuscripts, we plan to invite authors to complete a survey about their perceptions of both the LLM review reports and the peer reviewer reports for their manuscripts. We also plan to have a second editor perform the ratings and compute interrater agreement. Reviews produced by LLMs are not included in the decision-making for the manuscripts. Wilcoxon rank sum tests were used to compare LLM and human scores for each RQI item.

<h4>Results</h4> Preliminary data include 35 reviews (25 by LLMs and 10 by peer reviewers) of 5 BMJ submissions. Across 8 RQI items, LLM-generated reviews had higher mean (SD) scores than human reviewers on identifying strengths and weaknesses (4.12 [0.53] vs 2.70 [0.95]; P &lt; 0.001); providing useful comments on the writing, organization, tables, and figures (3.72 [0.79] vs 1.80 [0.63]; P &lt; .001); and constructiveness (4.00 [0.58] vs 3.00 [1.05]; P = .004) (<b>Table 25-1146</b>). Complete data will include 200 submissions to 4 BMJ journals, the secondary outcomes, and authors’ feedback on the LLM reviews.

![](https://assets.underline.io/markdown_image/1/image/b23f8733c131796f4e73f037ea693a62.png)

<h4>Conclusions</h4>
LLM-generated reviews matched or exceeded human reviewers on a few key dimensions of review quality. A fuller analysis will shed more light on the potential value of LLM peer reviews and how they could complement human peer reviewers’ work.
<h4>References</h4>
1. Publons. Global State of Peer Review report. <a href="https://publons.com/community/gspr">https://publons.com/community/gspr</a>

2. Liang W, Zhang Y, Cao H, et al. Can large language models provide useful feedback on research papers? a large-scale empirical analysis. <i>arXiv. </i>Preprint posted October 2,<i> </i>2023. <a href="https://doi.org/10.48550/arXiv.2310.01783">doi.org/10.48550/arXiv.2310.01783</a>

3. van Rooyen S, Black N, Godlee F. Development of the review quality instrument (RQI) for assessing peer reviews of manuscripts.<i> J Clin Epidemiol</i>. 1999;52(7):625-629. doi:10.1016/s0895-4356(99)00047-5

<sup>1</sup>University of Missouri-Columbia, Columbia, MO, US, fares.alahdab@health.missouri.edu; <sup>2</sup>University of Texas Health Science Center, Houston, TX, US; <sup>3</sup>BMJ Evidence-Based Medicine, London, UK; <sup>4</sup><i>BMJ</i>, London, UK.

<h4>Conflict of Interest Disclosures</h4>
<p> None reported.</p>


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