Medical Writing Generics and biosimilars Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
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Volume 28, Issue 2 - Generics and biosimilars

Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov

Abstract

According to the final rule on “Clinical Trials Registration and Results Information Submission”, clinical trial protocols and statistical analysis plans have to be published on ClinicalTrials.gov. The requirement affects all applicable clinical trials with a primary completion date on or after January 18, 2017. Personally identifiable information, as well as any trade secret and/or confidential commercial information can be redacted, before documents are made public. This article reviews the limited available guidance on how to prepare the documents for publication and the key questions to be addressed.

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References

  1. European Medicines Agency. Clinical data [cited 2019 Mar 9]. Available from: Available from: https://clinicaldata.ema. europa.eu/web/ cdp/home.
  2. US National Library of Medicine. ClinicalTrials.gov [cited 2019 Mar 9]. Available from: Available from: https://clinicaltrials.gov/ ct2/home.
  3. Food and Drug Administration. Food and Drug Administration Amendments Act of 2007. Public Law 110-85. 2007 Sep 27. [cited 2019 Mar 3]. Available from: Available from: https://www.govinfo.gov/content/pkg/ PLAW-110publ85/pdf/PLAW- 110publ85.pdf.
  4. US Department of Health and Human Services. Clinical Trials Registration and Results Information Submission; Final Rule. Fed Regist 2016; 81:64981–5157 [cited 2019 Mar 3]. Available from: Available from: https://www.gpo.gov/fdsys/pkg/ FR- 2016–09–21/pdf/2016–22129.pdf.
  5. Zarin DA, Tse T, Williams RJ, Carr S. Trial Reporting in ClinicalTrials.gov –The Final Rule. New Engl J Med. 2016;375(20):1998–2004.
  6. Hanson H. Clinical trial results disclosure on ClinicalTrials.gov and EudraCT. Med Writ. 2018;27(2):44–8.
  7. Office of the Federal Register. Electronic Code of Federal Regulations, Title 42, Chapter I, Subchapter A, Part 11. 2016 Oct 1[cited 2019 Mar 3]. Available from: Available from: https://www.ecfr.gov/cgi-bin/retrieve ECFR?gp=&SID=734afae039216c2795bc b99ad8c6d9be&mc=true&n=pt42.1.11&r =PART&ty=HTML#se42.1.11_110.
  8. All Trials. Tell the FDA to identify and punish law breakers. 2018 Oct 28 [cited 2019 Mar 3]. Available from: Available from: http://www.alltrials.net/news/tell-the-fdato- identify-and-punish-law-breakers/.
  9. Piller C. Failure to report: A STAT investigation of clinical trials reporting. 2015 Dec 13 [cited 2019 Mar 8]. Available from: Available from: https://www.statnews.com/2015/ 12/13/ clinical-trials-investigation/.
  10. US Department of Health and Human Services. Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. Draft Guidance. 2018 Sep. [cited 2019 Mar 4]. Available from: Available from: https://www.fda.gov/ downloads/RegulatoryInformation/ Guidances/UCM607698. pdf.
  11. DeVito NJ, Bacon S, Goldacre B. FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results. 16 Feb 2018 [cited 2019 Mar 9]. Available from: Available from: https://www.biorxiv.org/content/biorxiv/ early/2018/03/12/266452.full.pdf.
  12. Evidence-Based Medicine DataLab. FDAAA TrialsTracker [cited 2019 Mar 3]. Available from: Available from: http://fdaaa.trialstracker. net/.
  13. DeVito N. FDAAA TrialsTracker: Milestones and Methodology Updates. 2019 Mar 6. [cited 2019 Mar 8]. Available from: Available from: https://ebmdatalab.net/fdaaatrialstracker- milestones-and-methodologyupdates/.
  14. US National Library of Medicine. ClinicalTrials.gov Protocol Registration and Results System [cited 2019 Mar 4]. Available from: Available from: https://prsinfo.clinicaltrials.gov/.
  15. US National Library of Medicine. Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Under 42 CFR 11.22(b) for Clinical Trials Initiated on or After January 18, 2017. 2018 Jun 27. [cited 2019 Mar 4]. Available from: Available from: https://prsinfo.clinicaltrials.gov/ACT_ Checklist.pdf.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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