Medical Writing Public Disclosure Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
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Volume 27, Issue 2 - Public Disclosure

Clinical trial results disclosure on ClinicalTrials.gov and EudraCT

Abstract

The range of clinical trial results informationthat must be made publicly accessible is everincreasing both in the United States and theEuropean Union. This brings a number ofchallenges, not least maintaining consistencyacross the publicly available data for a giventrial. Furthermore, differences exist in thespecific requirements for data disclosure onthe ClinicalTrials.gov and European UnionDrug Regulating Authorities Clinical Trialsdatabases. The planning of disclosure ofclinical trial results must occur alongsidepreparation to author the Clinical StudyReport in order to meet this important legalobligation.

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References

  1. Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). Available from Available from: https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission
  2. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Available from: Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
  3. Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801). Available from: Available from: https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82
  4. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Annals of Internal Medicine. Editorial published at Annals.org on 6 June 2017. Available from: Available from: http://www.icmje.org/ news-and-editorials/data_sharing_ june_2017.pdf.
  5. FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results. DeVito NJ, Bacon S, Goldacre B; EBM DataLab, University of Oxford. Available from: Available from: https://www.biorxiv.org/content/biorxiv/early/2018/02/20/266452.full.pdf
  6. Clinical trial assignment request template letter and template instructions. Available from: https://eudract.ema.europa.eu/ result.html.
  7. ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies. June 29, 2017. Available from: Available from: https://prsinfo.clinicaltrials.gov/results_definitions.html#Result_Baseline
  8. EMA Q&A – EudraCT Results training – session 16th December 2014. Available from: Available from: https://eudract.ema.europa.eu/docs/training/Questions%20from%20the%20V10%20workshop_16Dec2014.pdf
  9. EMA EudraCT V9 Workshop – Managing users and prepare results in EudraCT, 15th November 2013. Q&A documents. Available from: Available from: https://eudract.ema.europa.eu/docs/training/List%20of%20questions%20from%20V9%20Workshop_15November13.pdf
  10. EudraCT result related data Dictionary. Available from: Available from: https://eudract.ema.europa.eu/result.html
  11. Regulation (EC) No 1901/2006. Available from: Available from: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
  12. Regulation (EC) No 1902/2006. Available from: Available from: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1902/reg_2006_1902_en.pdf
  13. Commission Guideline 2009/C28/01. Available from: Available from: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf
  14. ClinicalTrials.gov PRS Results Schema. Available from: Available from: https://prsinfo.clinicaltrials.gov/prs-xml-schemas.html
  15. EudraCT XML schemas and documentation. Available from: Available from: https://eudract.ema.europa.eu/result.html

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