2021 / 02

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DOI: 10.24075/medet.2021.014

ORIGINAL RESEARCH

Transparency in clinical trials

Pavlov ChS1, Varganova DL2, Svistunov AA1, Gluud C3
About authors

1 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia

2 Ulyanovsk State Clinical Hospital, Ulyanovsk, Russia

3 Сlinical Trial Unit, Coppenhagen, Denmark

Correspondence should be addressed: Daria L. Varganova
3-Internatsionala str. 7, Ulyanovsk, 432063; ur.ay@hcitad

About paper

Author contribution: Pavlov ChS – original concept, manuscript writing and editing; Varganova DL – literature analysis, manuscript writing; Svistunov AA, Gluud C – part in the concept and structure of the paper, manuscript editing.

Received: 2021-05-02 Accepted: 2021-05-25 Published online: 2021-10-13
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  1. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021). Cochrane, 2021. Available from www.training.cochrane.org/handbook.
  2. Fanelli D. Do pressures to publish increase scientists’ bias? An empirical support from US States Data. PLoS ONE. 2010; 5(4):e10271.
  3. World Medical Association. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Last update: October 2013; wma net. Available from www.wma.net/en/30publications/10policies/b3/.
  4. World Health Organization. Trial Registration; International Clinical Trials Registry Platform (ICTRP). Last update: August 2014; who int. Available from www.who.int/ictrp/trial_reg/en/
  5. Food and Drug Administration Modernization Act of 1997. Public Law 105-115; 105th Congress. Available from www.govinfo.gov/content/pkg/STATUTE-111/pdf/STATUTE-111-Pg2296.pdf.
  6. Press Release: National Institutes of Health Launches "ClinicalTrials.gov". Available from www.nlm.nih.gov/archive/20040831/news/press_releases
  7. International Committee of Medical Journal Editors. Registration of clinical trials. Available from www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html.
  8. International Clinical Trials Registry Platform (ICTRP). Available from www.who.int/clinical-trials-registry-platform
  9. Declaration of Helsinki Stakeholders Meeting in Washington, DC. WJM, 2013; 4(59):132-135. Available from www.wma.net/wp-content/uploads/2016/11/wmj201304.pdf
  10. European Medicines Agency launches a new version of EudraCT EMA/563462/2013. Available from www.ema.europa.eu/en/news/european-medicines-agency-launches-new-version-eudract
  11. HHS and NIH take steps to enhance transparency of clinical trial results. 2014. Available from www.nih.gov/news-events/news-releases/hhs-nih-take-steps-enhance-transparency-clinical-trial-results
  12. The National Cancer Institute Policy Ensuring Public Availability of Results from NCI-supported Clinical Trials. 2015. Available from www.grants.nih.gov/grants/guide/notice-files/NOT-CA-15-011.html
  13. Clinical Trials Registration and Results Information Submission, 2016. Available from www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission.
  14. Federal Policy for the Protection of Human Subjects, 2017. Available from www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects
  15. Ottawa Group. Ottawa Statement on Trial Registration. Available from www. ottawagroup.ohri.ca.
  16. A brief history of Cochrane. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021). Cochrane, 2021. Available from www.training.cochrane.org/handbook.
  17. OECD Principles and Guidelines for Access to Research Data from Public Funding. Available from https://www.oecd.org/sti/inno/38500813.pdf
  18. Final NIH Policy for Data Management and Sharing. Available from https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html
  19. Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, D.C.: The National Academies Press; 2014. Available from www.nap.edu/openbook.php?record_ id=18610
  20. All Trials Campaign. What All Trials is calling for Last update: November 2014; Sense About Science. Available from www.alltrials.net/wp-content/uploads/2013/09/What-does-all-trials-registered-and-reported-mean.pdf
  21. Yale University Open Data Access (YODA) Project Procedures to Guide External Investigator Access to Clinical Trial Data Last Updated February 2019. Available from www.yoda.yale.edu/how-request-data
  22. Clinical study data request.com. Available from www.clinicalstudydatarequest.com
  23. Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, D.C.: The National Academies Press; 2015. Available from www.nap.edu/catalog.php?record_id=18998
  24. Transparency and Registration in Clinical Research in the Nordic Countries, 2015. Available from www.nta.nordforsk.org/projects/nta_transparency_report.pdf .
  25. Viergever RF, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open 2015;5:e008932. DOI: 10.1136/bmjopen-2015-008932
  26. International Conference on Harmonization Guideline for International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Guideline for Good Clinical Practice E6 (R1). ICH Harmonized Tripartite Guideline. 10 June 1996. Available from www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
  27. The Consort Group. Consort statement. Last update: March 2010; www world psychiatric association org. Cited: 2009 Apr. 7. (7th Congress in Vienna, Italy) Available from http://www.consort-statement.org/
  28. DeVito, Nicholas J; Bacon, Seb; Goldacre, Ben (2020). Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. The Lancet, S0140673619332209 –. DOI:10.1016/S0140-6736(19)33220-9
  29. Al-Shahi SR, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014; 383(9912):176-185