Medical Writing Public Disclosure Clinical trial disclosure and transparency
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Volume 27, Issue 2 - Public Disclosure

Clinical trial disclosure and transparency

Abstract

The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure of
clinical trials in public databases has progressed to a new level, encompassing not only registration of new trials but also the disclosure of summary results for completed clinical trials for all drugs investigated in clinical trials, irrespective of their marketing approval status. Further development currently being implemented is the sharing of de-identified/anonymised trial participant data sets, thereby enabling re-analysis.
The Regulation EU No. 536/2014 is an EU law that instructs trial sponsors on the organisational, reporting, and disclosure aspects of clinical trials. The content of Regulation EU No. 536/2014 is intertwined with other obligations relevant to clinical trial disclosure and transparency efforts. Overlaps of the Regulation EU No. 536/2014 to other pertinent laws, policies, or required practices are summarised in this article, and some
practical examples are provided for stake - holders who are involved in the planning, evaluation, and preparation of documents relevant to clinical trials.

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References

  1. Yale Collaboration for Research Integrity and Transparency. Promoting transparency in clinical research: why and how. November 2017 [cited 2018 March]. Available from: https://law.yale.edu/system/files/area/center/crit/document/crit_white_paper_november_2017_best_.pdf
  2. Alfonso F, Adamyan K, Artigou JY, et al. Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors’ Network. Acta Cardiol Sin. 2017;33:315–22.
  3. Thomas KB. Clinical Trial Disclosure and Transparency: The Medical Writer’s Perspective; in Thomas KB, Reeves A, (eds):EMWA Symposium. EMWA, 2014, pp 6–17. Available from: http://www.emwa.org/Documents/Transparency%20Symposium%20Budapest%20Final.pdf
  4. Thomas KB. Clinical trial disclosure and transparency: ongoing developments on the need to disclose clinical data. in Medical writing the backbone of clinical development. International Clinical Trials. 2017;63-70. Available from: http://edition.pagesuite-professional.co.uk/launch.aspx?eid=f6b80f6a-ddd6-4705-bc9a-8af003f96adb
  5. European Parliament and Council of the European Union. New Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance. Official Journal of the European Union. 2014;L 158:1-76, Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
  6. EMA. Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”. European Medicines Agency 2015;EMA/228383/2015 Endorsed: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015-10/WC500195084.pdf
  7. EMA. Functional specifications for the EU portal and EU database to be audited. European Medicines Agency 2015;EMA/ 42176/2014 Rev. 1, Corr. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014-12/WC500179339.pdf
  8. European Parliament and Council of the European Union. Directive 2001/20/EC of The European Parliament and of The Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Union 2001;L 121/34.- Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
  9. European Parliament and Council of the European Union. Regulation (EC) No 1901/2006 of the European Parliament and of the council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/ EC and Regulation (EC) No 726/2004. Official Journal of the European Union 2006;L 378/1. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
  10. Petrini C. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview. Ann Ist Super Sanita. 2014;50:317–21.
  11. Department of Health and Human Services. Clinical Trials Registration and Results Information Submission; Final Rule. 42 CFR Part 11. Federal Register 2016;81 No. 183:64981-65157 Available from: http://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22129.pdf
  12. Zarin DA, Tse T, Williams RJ, Carr S. Trial Reporting in ClinicalTrials.gov –The Final Rule. N Engl J Med. 2016 Nov 17;375(20): 1998–2004.
  13. EMA. Trial results: Modalities and timing of posting. European Medicines Agency 2018 Available from: https://eudract.ema.europa.eu/docs/guidance/Trial%20results_Modalities%20and%20timing%20of%20posting.pdf
  14. FDA. FDAAA, Public Law No.110-85 § 801; US Food and Drug Administration. Public Law 110-85 2007;VIII:904-922 Available from: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82
  15. EMA. European Medicines Agency policy on publication of clinical data for medicinal products for human use. European Medicines Agency 2014;EMA/240810/2013 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014-10/WC500174796.pdf
  16. EMA. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. European Medicines Agency 2016;EMA/ 90915/2016 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016-03/WC500202621.pdf
  17. EMA. Summaries of clinical trial results for laypersons. Recommendations of the expert group on clinical trials for the implementation of Regulation EU No 536/2014 on clinical trials on medicinal products for human use. EMA 2018;Version 2. Available from: https://ec.europa.eu/health/sites/health/file s/files/eudralex/vol-10/2017_01_26_ summaries_of_ct_results_for_laypersons. pdf
  18. TransCelerate. Recommendations for drafting non-promotional lay summaries of clinical trial results. TransCelerate Biopharma Inc 2015 Available from: http://www.transceleratebiopharmainc.com/wp-content/uploads/2015/04/TransCelerate-Non-Promotional-Language-Guidelines-v10-1.pdf
  19. ICMJE. Clinical Trials Registration. FAQs. icmje org 2018; Available from: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration
  20. Taichman DB, Sahni P, Pinborg A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Ann Intern Med. 2017;167:63–5.
  21. Warren E. Strengthening research through Data Sharing. N Engl J Med. 2016;375: 401–3.
  22. EMWA. Transparency of clinical trial data – where does medical writing fit in? 2nd European Medical Writers Association Symposium 2014; Available from: http://www.emwa.org/Documents/Transparency%20Symposium%20Budapest%20Final.pdf
  23. Ohmann C, Banzi R, Canham S, et al. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open. 2017;7:e018647.
  24. Chan AW, Hrobjartsson A. Promoting public access to clinical trial protocols: challenges and recommendations. Trials. 2018;19:116.
  25. Li G, Abbade LPF, Nwosu I, et al. A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. BMC Med Res Methodol. 2018;18:9.
  26. Rosati P, Porzsolt F, Ricciotti G, et al. Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish. Trials. 2016;17:430.
  27. Chan AW, Pello A, Kitchen J, et al. Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications. JAMA. 2017;318:1709–11.
  28. DeVito NJ, Bacon S, Goldacre B. FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results. EBM Datalab; University of Oxford 2018; Available from: http://www.biorxiv.org/content/early/2018/03/12/266452
  29. Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA 2016;316:1353–4.

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