Volume 24, Issue 1 - Plain Language and Readability

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

Authors: Kamila Sroka-Saidi, Barbara Boggetti, Thomas M. Schindler

Abstract

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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