Medical Writing Plain Language and Readability Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results

Volume 24, Issue 1 - Plain Language and Readability

Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results

Abstract

The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to be finalised EU database. In this article, we review the proposed content of the layperson summary and identify issues related to the writing of such documents.

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References

  1. World Medical Association Declaration of Helsinki, 2008 [cited 2014 Nov]. Available from: http://www.wma.net/en/30publications/10policies/b3/17c.pdf
  2. ClinicalTrials.gov [2014 October; cited 2014 Oct]. Available from: https://clinicaltrials.gov/
  3. Section 801 of the Food and Drug Administration Amendments Act of 2007 [cited 2014 Nov]. Available from: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
  4. 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 [cited 2014 Nov]. Available from: http://ec.europa.eu/health/files/eudralex/vol-10/2012_302-03/2012_302-03_en.pdf
  5. EMA press release [2013 June; cited 2014 Oct]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/news_detail_002127.jsp&mid=WC0b01ac058004d5c1
  6. European Federation of Pharmaceutical Industries and Associations, Pharmaceutical Research and Manufacturers of America: Principles for responsible clinical trial data sharing: our commitment to patients and researchers, 18 Jul 2013 [cited 2014 Oct]. Available from: http://phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf
  7. 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 [cited 2014 Nov]. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.158.01.0001.01.ENG
  8. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [cited 2014 Nov]. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf

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Get real: Avoiding corporate gobbledygook
Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results
Profile: An interview with Art Gertel on the Budapest Working Group
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English Grammar and Style Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 2 – Single syntactic unit revision
Regulatory Writing Briefing documents: A case apart
Medical Communications
Lingua Franca and Beyond
Out on Our Own

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Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

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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

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Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk