Publications

 

WHO publications

Global action plan for clinical trial ecosystem strengthening

This plan sets out nine key action areas to improve innovation, design, conduct, and oversight of clinical trials. It supports implementation of WHO’s...

Guidance for best practices for clinical trials

This document responds to requests by the World Health Assembly to the Director-General in resolution WHA75.8 (2022) on strengthening clinical trials...

 This is a global presentation of the STV: its key features, aims, methods, procedures and outputs.Presentation available in french.  

Cover of the Solidarity vaccines trial publication

This flipbook is for staff of the Solidarity Trial Vaccines (STV). It is a resource that can be used to guide conversation and information exchange between...

This document draws on the World Health Organization’s Good Participatory Practice Guidelines for Emerging Pathogens (GPP-EP) (2016) which were adapted...

Other publications

Enhancing global clinical trial transparency for better health outcomes for all  
Zhang W, DeVito NJ, Chan AW et al. F1000Research 2025; 14:626

Reporting summary results in clinical trial registries: updated guidance from WHO 
Chan AW, Karam G, Pymento J et al. Lancet Glob Health 2025; 13: e759–68

Searching clinical trials registers: guide for systematic reviewers 
Hunter K, Webster A, Page M et al. BMJ 2022;377:e068791

Promotion of data sharing needs more than an emergency: An analysis of trends across clinical trials registered on the International Clinical Trials Registry Platform 
Merson L, Ndwandwe D, Malinga T et al. Wellcome Open Res 2022, 7:101

Registration of clinical trials in Russia: How does it compare with the World Health Organization International Clinical Trials Registry Platform standards? 
Nurkhametova D, Karam G, Ziganshina LE. Clinical Trials. 2021;18(3):383-385.

Clinical trial registration: A practical perspective 
Bhaskar S (2018). Indian J Anaesth 2018;62:10-5.

Clinical trial transparency in the Americas: the need to coordinate regulatory spheres 
Lemmens T, Herrera Vacaflor C . BMJ 2018
;362:k2493

Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results
Moorthy VS, Karam G, Vannice KS, Kieny M-P (2015). PLoS Med 12(4): e1001819.

The Quality of Registration of Clinical Trials: Still a Problem 
Viergever RF, Karam G, Reis A, Ghersi D (2014). PLoS ONE 9(1): e84727.

Pharmacokinetic research in children: an analysis of registered records of clinical trials.
Viergever RF, Rademaker CMA, Ghersi D. BMJ Open, 2011; 1:e000221. doi:10.1136/bmjopen-2011-000221.

The Quality of Registration of Clinical Trials.
Viergever RF, Ghersi D. PLoS ONE, 2011; 6(2): e14701. doi:10.1371/journal.pone.0014701.

From Mexico to Mali: four years in the history of clinical trial registration.
Ghersi D, Pang T. Journal of Evidence-Based Medicine.

Clinical trials registry advances in Latin America and the Caribbean.
Newsletter VHL 086 21/January/2009.

Clinical trials in India: ethical concerns.
Bulletin of the World Health Organization. Volume 86, Number 8, August 2008, 577-656.

En route to international clinical trial transparency.
Ghersi D, Pang T. The Lancet, 2008; 372: 1531-1532.

Clinical trials in India: ethical concerns.
Bulletin of the World Health Organisation. 2008; 86(8).

Reporting the findings of clinical trials: a discussion paper.
Ghersi D, Clarke M, Berlin J, Gulmezoglu M, Kush R, Lumbiganon P, Moher D, Rockhold F, Sim I & Wager E. Bulletin of the World Health Organisation. 2008; 86(6).

Clinical trial registration: transparency is the watchword.
Ida Sim, An-Wen Chan, A Metin Gülmezoglu, Tim Evans and Tikki Pang: The Lancet, 2006; 367: 1631-1633.

WHO Facilitates International Collaboration in Setting Standards for Clinical Trial Registration
Gülmezoglu M, Pang T, Horton R, Dickersin K. The Lancet, 2005; 365: 1829-1831.

Registering Clinical Trials: An Essential Role for WHO
Evans T, Gülmezoglu M, Pang T. The Lancet, 2004; 363: 1413-1414.

WHO clinical trials initiative to protect the public
Bulletin of the WHO, Jan 2006; 84(1).

WHO - 58th Meeting of The World Health Assembly

WHO - The Mexico Statement on Health Research

 

External Sources

The provision of a link from the WHO website to other sites does not indicate endorsement of those sites by WHO, and WHO accepts no responsibility for the validity or accuracy of their content.

Identifying trials run in India, registered with ClinicalTrials.gov, is not straightforward Samanta AD, Mendiratta J, Saberwal G. Journal of Biosciences, 50: 27. (2025)

Depression clinical trials worldwide: a systematic analysis of the ICTRP and comparison with ClinicalTrials.gov
Namiot ED, Smirnovová D, Sokolov AV et al. Transl Psychiatry 2024. 14, 315.

The international clinical trials registry platform (ICTRP): data integrity and the trends in clinical trials, diseases, and drugs
Namiot ED, Smirnovová D, Sokolov AV et al: Front. Pharmacol 2023. 14:1228148

Review of the Registration in the Clinical Research Information Service
Choi E-K, et al. : Journal of Korean Medical Sciences 2016; 31: 1-8

Clinical Trial Registration in the Eastern Mediterranean Region.
Muttappallymyalil, J., and John, L. J. Oman Medical Journal 2014 Jan; 29(1): 1-2. Doi: 10.5001/omj.2014.01

Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications.
Helfand, M., Paynter, R., McDonagh, M., Guise, J., Zarin, D. A., Hartung, D. M. Annals of Internal Medicine 2014; 160(7): 477-483. Doi: 10.7326/M13-0480

Evaluating adherence to the International Committee of Medical Journal Editors’ policy of mandatory, timely clinical trial registration.
Cimino, J. J., and Huser, V. Journal of the American Medical Informatics Association (JAMIA) 2013 June; 20(e1): e169-e174. Doi: 10.1136/amiajnl-2012-001501

Restoring invisible and abandoned trials: a call for people to publish the findings.
Jefferson, T., Vedula S. S., Healy, D., Dickersin, K., and Doshi, P. BMJ 2013 June; 346: f2865. Doi: http://dx.doi.org/10.1136/bmj.f2865

Moving forward: the case for the prospective registration and reporting of all clinical trials.
Carlo, R. Journal of the Bahrain Medical Society 2013; 24(2): 93-94.

Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.
Prayle, A. P., Hurley, M. N., and Smyth, A. R. BMJ 2012 Jan; 344: d7373. Doi: http://dx.doi.org/10.1136/bmj.d7373.

Clinical trial registration in the Eastern Mediterranean Region: a luxury or a necessity?
Shideed, O., and Al-Gasseer, N. Eastern Mediterranean Health Journal 2012, 18(2): 108-111.

The ClinicalTrials.gov Results Database – Update and Key Issues.
Ide, N. C., Califf, R. M., Williams, R. J., Tse, T., Zarin, D. A. NEJM 2011 March; 364: 852-860. Doi: 10.1056/NEJMsa1012065

Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group.
Krleža-Jerić, K. PLOS Med 2005 Oct; 2(11): e378. Doi: 10.1371/journal.pmed.0020378

Registering clinical trials: an essential role for WHO.
Pang, T., Gulmezoglu, M., and Evans, T. The Lancet, 2004 May; 363(9419): 1413-1414. Doi: 10.1016/S0140-6736(04)16136-9.

Transparenz in klinischer Forschung – ein Muss [Transparency in Clinical Research - a Must]
Dr. Gerd Antes. Berliner Ärzte 10/2010.

Publishing information about ongoing clinical trials for patients
Fiona Godlee, Iain Chalmers. BMJ 2010; 340: c725.

New Law May Be Having Some Effect on Publication Bias
Rabiya S. Tuma. JNCI Journal of the National Cancer Institute 2010; 102(5): 290-292. doi:10.1093/jnci/djq051.

Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials
Sylvain Mathieu, MD; Isabelle Boutron, MD, PhD; David Moher, PhD; Douglas G. Altman, DSc; Philippe Ravaud, MD, PhD. JAMA. 2009; 302(9): 977-984.

Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. PLoS Med, 2009; 6(9): e1000144. doi:10.1371/journal.pmed.1000144.

Clinical trial registration gains momentum in India
Indian J Med Res, July 2009; 130: 85-86.

Randomized trials published in some Chinese journals: how many are randomized?
Taixiang Wu, Youping Li, Zhaoxiang Bian, Guanjian Liu and David Moher. Trials, 2009; 10: 46. doi:10.1186/1745-6215-10-46.

Making information about clinical trials publicly available
Rosalind L Smyth. BMJ, 2009; 338: b2473.

Registration of trials in children: update of current international initiatives
Chiara Pandolfini, Maurizio Bonati, Helen M Sammons. Arch Dis Child, 2009; 94: 717-719. doi:10.1136/adc.2008.148155.

7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials
Karmela Krleža-Jerić, Trudo Lemmens. doi:10.3325/cmj.2009.50.105.

Assessment of registration quality of trials sponsored by China
Xuemei Liu, Youping Li, Xinting Yu, Juan Feng, Xunshu Zhong, Xiaoyan Yang, Jing Li. JEBM, 2009 Mar; 2(1): 8-18. doi: 10.1111/j.1756-5391.2009.01007.x.

Prospective Registration of Clinical Trials in India: Strategies, Achievements & Challenges
Prathap Tharyan. JEBM, 2009 Mar; 2(1): 19-28. doi: 10.1111/j.1756-5391.2009.01015.x.

Establishing the Sri Lanka Clinical Trials Registry
Udaya K Ranawaka, Colvin Goonaratna. JEBM, 2009 Mar; 2(1): 29-31. doi: 10.1111/j.1756-5391.2009.01003.x.

Iranian Registry of Clinical Trials: path and challenges from conception to a World Health Organization primary register
Masoud Solaymani-Dodaran, Afshin Ostovar, Davood Khalili, Muhammad Vasei. JEBM, 2009 Mar; 2(1): 32-35. doi: 10.1111/j.1756-5391.2009.01002.x.

The German Clinical Trials Register: challenges and chances of implementing a bilingual registry
Hanna Hasselblatt, Gabriele Dreier, Gerd Antes, Martin Schumacher. JEBM, 2009 Mar; 2(1): 36-40. doi: 10.1111/j.1756-5391.2009.01001.x.

Background, introduction and activity of the Japan Primary Registries Network
Tomonori Shiokawa. JEBM, 2009 Mar; 2(1): 41-43. doi: 10.1111/j.1756-5391.2009.01013.x.

Progress and Deficiencies in the Registration of Clinical Trials
Alastair J.J. Wood, M.D. N Engl J Med, 2009 Feb; 360(8): 824-30.

Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation
Rising K, Bacchetti P, Bero L. PLoS Med; 5(11): e217. doi:10.1371/journal.pmed.0050217.

Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results
Chan A-W. PLoS Med; 5(11): e230. doi:10.1371/journal.pmed.0050230.

Next Stop, Don't Block the Doors: Opening Up Access to Clinical Trials Results
The PLoS Medicine Editors. PLoS Med; 5(7): e160. doi:10.1371/journal.pmed.0050160.

Latin American Ongoing Clinical Trial Register (LATINREC)
Reveiz L, Delgado MB, Urrutia G, Ortiz Z, Garcia Dieguez M, Martí-Carvajal A, Calgua E, Vieyra A, Ciapponi A, Hidalgo R, Pantoja T, Sanchez LM, Martínez Pecino F, Tristan M. Rev Panam Salud Publica. 2006; 19(6): 417-422.

Enregistrement et publication des essais cliniques
Burnand B, Rège Walther M. Bulletin des médecins suisses. 2005; 86(8): 480-481.

Registrierung und Veröffentlichung klinischer Studien
Burnand B, Rège Walther M. Schweizerische Ärztezeitung. 2005; 86(8): 482-483.

Boletín Impacto - Los editores de revistas médicas amplían sus exigencias para lograr una investigación más transparente (February 2008)

Global Forum Update on Research for Health Volume 4: Equitable access: Research challenges for health in developing countries

Trudo Lemmens and Ron A Bouchard, Mandatory clinical trial registration: rebuilding public trust in medical research

The New England Journal of Medicine - Editorials - Open Clinical Trials (25 October 2007)

ICMJE - Update on Trials Registration: Clinical Trial Registration: Looking Back and Moving Ahead

IFPMA - Joint Position on the Disclosure of Clinical Trial Information Via Clinical Trial Registries and Databases

WAME Policy Statements - The Registration of Clinical Trials (July 2005)

ICMJE - Is This Clinical Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors

Ottawa Statement - Principles for international registration of protocol information andresults from human trials of health related interventions: Ottawa Statement (part 1)

An international standard for disclosure of clinical trial information. BMJ 2006;332;1107-1108 (Extract)

Ottawa Statement

ICMJE - Update on Trials Registration: October 2004

ICMJE - Editorial - Clinical Trial Registration: A Statement from the International

Good Publishing Practice for Pharmaceutical Companies