FDAAA Legislation: Global Implications for Clinical Trial Reporting and Publication Planning - expert review now available
12 November 2008, NetworkPharma Ltd, Oxford, UK have published another in their new KeywordPharma series of Expert Reviews intended for individuals working in and around the global pharmaceutical industry.
FDAAA Legislation: Global Implications for Clinical Trial Reporting and Publication Planning written by Liz Wager is now available for purchase.
The Food and Drug Administration Amendments Act (or FDAAA), which was passed in 2007, has major implications for drug companies that plan to market their products in the USA. Section 801 of the Act outlines the ways in which clinical trials need to be reported. Most notably, it makes registration and the public reporting of results mandatory for certain clinical studies, through the www.ClinicalTrials.gov website.
The legislation applies to all FDA-approved medical products licensed for use in the USA and for products that are due to be submitted for marketing approval to the FDA. All controlled clinical investigations other than phase I studies are covered by the Act.
Although FDAAA is US legislation, it is likely to have consequences far beyond the USA and may profoundly affect the ways in which clinical trials are reported and made public. The legislation has implications for the publication of clinical trial findings in peer-reviewed journals, as well as for the clinical trial registers recognised by the International Committee of Medical Journal Editors.
This report, FDAAA Legislation: Global Implications for Clinical Trial Reporting and Publication Planning, describes the requirements for trial registration and the reporting of results, and explains what companies need to do now. Since the legislation is open-ended, and several aspects will not come into force for the next couple of years, the report also analyses future implications and highlights currently unanswered questions.
The first phase of FDAAA implementation, with elements governing clinical trial reporting, was due to come into force in late September 2008. Despite its US focus, it is clear that, globally, companies need to have systems in place to ensure they comply with this new legislation.
All KeywordPharma publications can be purchased from ThePharmYard at www.ThePharmYard.com
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About the author
Elizabeth (Liz) Wager is a member of the World Health Organization (WHO) Scientific Advisory Group on trial registration, the CONSORT statement group, the BMJ’s Ethics Committee, and the World Association of Medical Editors Ethics Committee. She is Secretary of the Committee on Publication Ethics and a Visiting Fellow of the UK Cochrane Centre. She is a regular peer-reviewer for several journals including the BMJ, the Journal of Medical Ethics, PLoS Medicine and JAMA.
After obtaining a First Class zoology degree from Oxford in 1983 she worked for Blackwell Scientific Publications, Janssen-Cilag then Glaxo- Wellcome. In 2001, she set up her own company, Sideview, which provides training, writing, editing and publication consultancy services. She has advised numerous drug companies and communication agencies about trial registration and publication policies, and has run workshops on five continents.
Liz has written books on ‘Getting Research Published: an A to Z of Publication Strategy’ and ‘How to Survive Peer Review’. She is a co-author of ‘Good Publication Practice for Pharmaceutical Companies’ and the European Medical Writers Association guidelines on the role of medical writers.
Written by pharmaceutical industry specialists, KeywordPharma publications are designed to be authoritative, relevant, succinct and helpful to pharmaceutical industry executives in their day-to-day work and in their longer term career development. Available to purchase individually as e-documents, they build into a specialist knowledge library for everyone working in and around the global pharmaceutical industry.
Developed and managed by NetworkPharma Ltd, ThePharmYard provides instant access to a unique database of specialist information which is particularly relevant to individuals working within the medical and pharmaceutical industries around the world. Titles from a diverse range of independent publishers are available to purchase in electronic document format for immediate access.
NetworkPharma Ltd is an independent, specialist company founded by Peter Llewellyn, to focus on novel approaches to disseminating information within the global medical and pharmaceutical industries. Peter Llewellyn previously founded and built the leading industry portal site, InPharm, which was subsequently purchased by John Wiley & Sons to manage alongside their other industry services, PharmaFile and Pharmafocus.
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