Medical Writing The Medical Writing Business Regulatory Writing: New developments in public disclosure of clinical trials

Volume 24, Issue 3 - The Medical Writing Business

Regulatory Writing: New developments in public disclosure of clinical trials

Abstract

In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement reiterates the previous WHO statement on registration of trial methods prior to initiation and extends it to include the timely publication of results, both in clinical trial registries and in peer reviewed journals. The aim is to ensure that negative results are not underreported, thereby distorting efficacy conclusions derived from publicly available data. The statement also calls for sponsors to make the results of past trials available. Finally, the statement suggests more rigorous identification of trial registry identification in subsequent publications and data sharing initiatives, presumably to make meta-analyses easier. The statement was accompanied by a detailed rationale published in PLoS1 and a commentary, also in PLoS,2 by Ben Goldacre, a prominent campaigner for full disclosure of clinical trial results.

References

  1. Moorthy VS, Karam G, Vannice KS, Kieny M-P. Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results. PLoS Med. 2015;12(4):e1001819.
  2. Goldacre B. How to get all trials reported: audit, better data, and individual accountability. PLoS Med. 2015;12(4):e1001821.
  3. Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015;372(11):1031–9.
  4. Goodyear M. Learning from the TGN1412 trial. BMJ. 2006;332(7543):677–8.
  5. Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013;347:f6104.

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Articles

In this issue… The Medical Writing Business
President's Message
Setting up and running a medical writing company
For the greater good…Can agency competitors cooperate to advance medical publication practices?
The Section of Scientific Publications at the Texas Heart Institute
Is cheap outsourcing a threat to your career?
Successfully outsourcing medical writing
Freelancing – Are you ready to go solo?
News from the EMA
European Science Editing: May 2015 picks
Profile: An interview with Dawn Bentley: How personal branding can advance your professional career!
The Webscout
In the Bookstores
Regulatory Writing: New developments in public disclosure of clinical trials
Lingua Franca and Beyond
Gained in Translation
HIV research fraudster handed stiff prison sentence
English Grammar and Style: Good Writing Practice
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Medical Communications
Out On Our Own

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Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

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Alicia Waltman

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Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

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Nicole Bezuidenhout 

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Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

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

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk