Volume 24, Issue 4 - Writing for Lay Audiences

Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance

Author: Claire L. Gillow

Abstract

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References

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8. US Government. FDAAA. Title VIII - Clinical trial databases. Public Law 110-85. 2007 Sep;121 stat:904-922. Available from: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf
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12. Ctep.cancer.gov. CTCAE v4.0 terms with lay terms [cited 2015 Aug 29]. Available from: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcae_4_with_lay_terms.pdf
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14. European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1. 2009 Jan. Available from: http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf
15. Ema.europa.eu. c1995-2015 EMA [cited 2015 Aug 29]. Examples of EPAR and RMP for Plegridy™. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002827/human_med_001782.jsp&mid=WC0b01ac058001d124
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17. Cancerresearchuk.org. Cited 2015 Aug 29. Note: click on about cancer, clinical trials, type in drug name, tick ‘have results available’ search, select clinical trial and click on trial results + to show lay results. Available from: http://www.cancerresearchuk.org/
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