Adherence to the WHO Statement on Public Disclosure of Clinical Trial Results by Trials Published in High Impact Factor Journals

Carolina Grana,^1,2,3 Lina Ghosn,^1,2,3 Carolina Riveros,^1,2,3 Philippe Ravaud,^1,2,3 Isabelle Boutron^1,2,3

Objective

The World Health Organization (WHO) requests that “key outcomes are to be made publicly available within 12 months of study completion by posting to the results section of the primary clinical trial registry.”¹ In some regions, this requirement is also mandated by law²; however, evidence indicates low adherence.³ The extent to which journal editors support this request remains unclear. This study aimed to assess adherence to the WHO request among randomized clinical trials (RCTs) published in high-impact journals and to examine whether journal editors encourage this practice in their recommendations to authors.

Design

We conducted a cross-sectional study and reported our findings according to the STROBE guideline. On April 18, 2025, we searched PubMed using the terms date-create: 01/01/2024 to 01/01/2025 AND journal: [Name of the journal], applying the “randomized controlled trial” filter. We selected the 5 journals with the highest impact factors in the “medicine, general & internal” category and in selected medical specialties based on the 2023 Clarivate Journal Citation Reports (Web of Science). We included RCTs evaluating pharmacologic, biologic, or medical device interventions. Data were extracted in duplicate from each trial publication and corresponding primary registry entry. We recorded the publication date, the trial’s primary completion date, and results status in the registry. The primary outcome was the proportion of RCTs that at the time of publication had results posted in the primary registry within 12 months of trial completion. The analysis was primarily descriptive, comparing the timing of trial completion, results posting, and publication.

Results

Preliminary results (publications up to June 2024) identified 185 RCTs published across 18 journals. Among these, 142 (77%) evaluated pharmacologic interventions and 108 (58%) were multinational. Trial sites included at least 1 European Union country in 102 trials (55%), the US in 94 (51%), and the UK in 74 (40%). All 185 trials were registered, and 163 (88%) registrations were prospective. A total of 100 trials (54%) were published more than 12 months after their primary completion date. Among these, at the time of publication, only 23 (23%) had adhered to WHO requirements by having results posted in the trial registry within 12 months of completion. Conversely, 83 trials (45%) were published within 12 months of completion, and 45 of these (54%) had results posted in the registry when the trial report was published. Completion date was not reported for 2 trials (1%). None of the 18 journals assessed requested public posting of trial results in registries.

Conclusions

Preliminary findings from trials included in this study, all published in high–impact factor journals, revealed low adherence to the WHO call for timely posting of results to the registries.

References

1. WHO statement on public disclosure of clinical trial results. World Health Organization. Accessed January 10, 2025. https://www.who.int/news/item/09-04-2015-japan-primary-registries-network

2. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364(9):852-860. doi:10.1056/NEJMsa1012065

3. DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Lancet. 2020;395(10221):361-369. doi:10.1016/S0140-6736(19)33220-9

¹Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France, isabelle.boutron@aphp.fr; ²Centre d’Épidémiologie Clinique, AP-HP, Hôpital Hôtel-Dieu, Paris, France; ³Cochrane France, Paris, France.

Conflict of Interest Disclosures

Isabelle Boutron is a member of the Peer Review Congress Advisory Board but was not involved in the review or decision for this abstract. No other disclosures were reported.

Additional Information

Carolina Grana (carolinaestela.granapossamai@aphp.fr) and Lina Ghosn (lina.elchall@aphp.fr) are co–corresponding authors.