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WHAT'S THIS?
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COMMENTARY << Clinical trial registries
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Publishing information about ongoing clinical trials for patients
Published 24 February 2010
It is often difficult for patients who want to take part in clinical trials to find the required information. In an Analysis article in the BMJ, Fiona Godlee and Iain Chalmers argue that their needs can and should be met.
[Link to original source material]
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Registering Clinical Trial Results: The Next Step
Published 24 February 2010
An Commentary in JAMA says the NIH, in developing its provisions and policies governing registration of the results of drug clinical trials on ClinicalTrials.gov, should focus on promoting improvements in the quality and reliability of clinical research on drugs. These improvements can occur only by increasing transparency and reproducibility. Mandatory registration of the protocols for drug clinical trials, as well as posting all patient-level data collected in those trials, are essential for clinical research on drugs to move to the next step.
[Link to original source material]
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Registration of observational studies
Published 18 February 2010
An Editorial in the BMJ says registration of observational studies is just one of many changes needed to increase confidence in observational research, but they believe it is the crucial next step. The aim would be to facilitate the design and reporting of observational research, not to hinder it. Trial registration has had a substantial and important positive effect on the design, conduct, and reporting of randomised clinical trials, and the BMJ believes it is time to extend those benefits to observational research.
[Link to original source material]
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Should protocols for observational research be registered?
Published 30 January 2010
An Editorial in The Lancet states they believe that when feasible, investigators should register observational studies on a WHO-compliant registry before they begin and points out that a mechanism already exists for this on many registries, including ClinicalTrials.gov, where almost 14 000 observational studies are listed.
[Link to original source material]
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Make trial publication compulsory in EU, says IQWiG
Published 26 November 2009
PharmaTimes reports that Germany's health technology assessment body, the Institute for Quality and Efficiency in Health Care (IQWiG) says that the German government should push for an EU regulation making it compulsory to register and publish within tight deadlines the results of all clinical trials.
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Pharma will have to disclose every trial undertaken
Published 10 November 2009
PharmaFocus reports that a new international code of conduct has been issued by the Council of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), requiring pharma firms to disclose every clinical trial they undertake.
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International trials registry is missing important information, study finds
Published 7 September 2009
Jacqui Wise reports in the BMJ that Researchers have found that important information is missing from many trials recorded on the international register of clinical trials ClinicalTrials.gov, the publicly accessible database of clinical trials managed by the US National Library of Medicine.
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Making information about clinical trials publicly available
Published 25 June 2009
Rosalind L Smyth, Brough professor of paediatric medicine at the Institute of Child Health, University of Liverpool and Alder Hey Children’s Hospital explains in a BMJ Editorial, how open access to information on the EudraCT database will improve transparency.
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Drug industry protests over need to register trial results
Published 22 April 2009
In the BMJ, it is reported that drug manufacturers this week expressed their concern about a new requirement of the world’s leading drug trial registry that the outcomes of all clinical trials have to be posted on the register within 12 months of completion of the trial.
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Public disclosure of clinical research
Published 18 April 2009
Comment in The Lancet from GSK authors outlines their approach to publishing all their clinical research data. They call on all those involved in the conduct and publication of clinical research to make the best possible efforts to ensure that the results of all studies are available in the public domain in ways that help inform medical judgment and advance medical science.
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Trial registration: advice to authors
Published 4 February 2009
Brief BMJ article on its criteria for registration of studies on a public trial registry.
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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]
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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]
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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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Strategic Medcomms Forum 2010: Reshaping the healthcare conversation
30 September 2010
Oxford University Musuem
The first of a series of annual events where we consider how the global medical and pharmaceutical industry engages with its stakeholders and we identify and debate future directions and implications for medical-marketing activity.
[View details here]
Organized by NetworkPharma.
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