Medical Writing Trends in medical writing Clinical trial disclosure: Perspective from a medical writer for a contract research organisation

Volume 28, Issue 3 - Trends in medical writing

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation

Abstract

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps: regulatory medical writing and clinical trial disclosure. I describe how disclosure captured my attention and the subsequent actions I have taken.

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References

  1. Official Journal of the European Union. Commission Guideline – Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. (2012/C 302/03). 2012 [cited 2019 Jun 13]. Available from: https://ec.europa.eu/ health/sites/health/files/files/eudralex/vo l-10/2012_302-03/2012_302-03_en.pdf.
  2. U.S. Food and Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007, Pub. L. No. 110-85, 121 Stat. 823. Section 801. Expanded clinical trial registry data bank. 2007 [cited 2019 Jun 13]. Available from: https://www.fda. gov/science-research/clinical-trials-and-human-subject-protection/fdas-roleclinicaltrialsgov- information.
  3. Federal Register. Department of Health and Human Services. Clinical Trials Registration and Results Information Submission; Final Rule, 42 CFR Part 11. 2016 [cited 2019 Jun 13]. Available from: https://www.federalregister.gov/document s/2016/09/21/2016-22129/clinical-trialsregistration- and-results-informationsubmission.
  4. European Medicines Agency. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. EMA/90915/2016 Version 1.4. 2018 [cited 2019 Jun 13]. Available from: https://www.ema.europa.eu/en/humanregulatory/ marketing-authorisation/ clinical-data-publication/supportindustry/ external-guidanceimplementation- european-medicinesagency- policy-publication-clinical-data.
  5. European Clinical Trials Database.EudraCT training – training environment. 2019 [cited 2019 Jun 13]. Available from: https://eudract-training.ema.europa.eu/.
  6. Clinicaltrials.gov. Protocol Registration and Results System (PRS). 2019 [cited 2019 Jun 13]. Available from: https://prstest.nlm.nih.gov/.
  7. European Medicines Agency. EudraCT Public website. Results documentation/ XML schemas and documentation. 2019 [cited 2019 Jun 13]. Available from: https://eudract.ema.europa.eu/result.html.
  8. Evidence-Based Medicine Data Lab, University of Oxford. EU Trials Tracker. Who’s not sharing EU clinical trial results? 2018 [cited 2019 Jun 13]. Available from: http://eu.trialstracker.net/.
  9. Evidence-Based Medicine Data Lab, University of Oxford. FDAAA TrialsTracker. Who’s sharing their clinical trial results? 2019 [cited 2019 Jun 13]. Available from: http://fdaaa.trialstracker.net/.
  10. EMWA-AMWA. CORE Reference (Clarity and Openness in Reporting: E3-based).2016 [cited 2019 Jun 13]. Available from: http://www.core-reference.org/.
  11. Review of the TransCelerate template for clinical study reports (CSRs) by the developers of CORE Reference (Clarity and Openness in Reporting: E3-based). 2019 [cited 2019 Aug 06]. Available from: https://rdcu.be/bM7fH.

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Articles

Introduction
President's Message
EMWA News
Omics in silico and other trends in biomedical research: Impact on how and what we write
Catching the wave of lifestyle medicine
Artificial intelligence – will we be replaced by robots?
Now more than ever, scientists must speak up for science
When less is more: Medical writers as guardians of curated content
Predatory publishing – what medical communicators need to know
AMWA – EMWA – ISMPP Joint Position Statement on Predatory Publishing
How to combat medical misinformation with a sound content strategy
Subcontracting: Not for the faint of heart
Lay summaries and writing for patients: Where are we now and where are we going?
Clinical trial disclosure: Perspective from a medical writer for a contract research organisation
The 360° approach to authoring risk management plans
Trends in regulatory writing: A brief overview for aspiring medical writers
The medical writing landscape in China
News from the EMA
Regulatory Matters
Medical Communications and Writing for Patients
In the Bookstores
Getting Your Foot in the Door
Veterinary Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk