Medical Writing Plain Language and Readability Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results
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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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English Grammar and Style Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 2 – Single syntactic unit revision
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