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This is a freely accessible online resource for everyone involved in publication planning. Help us build the site into a valuable resource for, amongst others, medical writers and communications professionals, pharmaceutical industry managers, medical journal editors and publishers. Please send your ideas, contributions and comments about the articles to the Editor of The Publication Plan, Mary Greenacre. If you have any other comments about the service, the web site, or questions about advertising and sponsorship, please contact the Publisher, Peter Llewellyn.

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COMMENTARY << Clinical trial registries

FDAAA Legislation: Global Implications for Clinical Trial Reporting and Publication Planning Published 15 November 2008 This report 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. Published in the KeywordPharma Expert Reviews series, the full report is available to download free of charge, sponsored by Complete Medical Group. [Link to original source material]

FEATURE ARTICLE for ThePublicationPlan.com – Impact of legislation and reporting standards on publication planning Published 11 November 2008 The publication planning landscape has changed dramatically over the past 10 years. We have moved from an arena largely free of restriction and regulation to one that has come under intense and sustained scrutiny from several sources – legislators, journal editors, medical societies, commentators and even mainstream newspapers. Today, many Pharma companies have publication policies and procedures in place to routinely register clinical trial protocols, and some have ensured that summaries of past trial results (published or not) are publicly available on their own registries. [Access full article here].

Mandatory disclosure of trial results for drugs and devices Published 26 January 2008 This article by Trish Groves, deputy editor of the BMJ, describes the 2007 FDA Amendment Act and its implications for publication of clinical trial results in journals. The Act requires that some results of most clinical trials of all drugs and devices that need approval by the FDA are posted onto clinicaltrials.gov from September 2008; the issue for journals is whether they will want to publish data that are already in the public domain. [Link to original source material]

Clinical trial registration Published 4 June 2007 This article outlines the position of the ICMJE with regard to clinical trial registries and publication of trial results in member journals. The ICMJE has stated that member journals will consider studies whose results have been posted on a registry, providing that no more than an abstract of 500 words or one table have been made public. This position is due to be reviewed in June 2008, and a statement is awaited with interest. [Link to original source material]

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