Medical Writing Writing for Patients Pharmaceutical clinical trials transparency and privacy
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Volume 29, Issue 4 - Writing for Patients

Pharmaceutical clinical trials transparency and privacy

Abstract

With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors to reveal trial results to participants and patients, physicians, and independent researchers. Since then, more requirements have emerged, including anonymisation and publication policies introduced by the EMA and Health Canada. Going beyond regulatory compliance, transparency leaders have launched voluntary data-sharing initiatives to enable researchers’ access to structured individual patient data. With this move toward greater transparency and the drive for more data, transparency functions working with the clinical trials environment need a broader toolkit of capabilities, including anonymisation, to protect participants’ privacy. The authors explored these emerging trends in a webinar for FDANews on July 23, 2020 (https://www.fdanews.com). FDANews has an 80,000-person database, mainly from the clinical trial space. This article summarises the webinar.

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Articles

Editorial - Writing for Patients
Editorials - Passing the Torch: The Sequel/Filling Big Shoes
Foreword: Writing for Patients, Foreword from the EMA
President's Message
EMWA News
Promoting equity in understanding: A cross-organisational plain language glossary for clinical research
Medical abbreviations with multiple meanings: A prescription for disaster
Writing for patients: When and how?
Lay summaries for Phase 1 trials in healthy volunteers
Participant information – an ethics committee view
Establishing a patient publication steering committee: A case study with insights for medical writers
Translation: A transcultural activity
Writing for the internet
Social Media: A tool that can benefit public health?
Partnering with patient associations: Engaging medical writers to support health literacy for patients
Pharmaceutical clinical trials transparency and privacy
News from the EMA
Medical Devices
Regulatory Matters
In the Bookstores
Good Writing Practice
My First Medical Writing
Getting Your Foot in the Door
Out on Our Own

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