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Date23 October 2012
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Better Transparency Around Clinical Trial Data: ICR Position Statement
Summary
Transparency around clinical trial data has been an important policy issue for a number of years. As technology and data security have improved, the clinical research community can now address this issue practically.

The Institute of Clinical Research confirms its support for the publication of clinical trial data from all studies, irrespective of outcome.

The European Medicines Agency has announced1 that it will proactively publish clinical trial data and enable access to full data sets by interested parties. A number of practical and policy issues need to be addressed before complex data sets can be made available.

The Institute of Clinical Research supports this move and is actively engaged with discussions around these practical issues. As such, we will be attending the EMA Workshop to discuss this topic in November.

We recognise that publishing clinical trial data facilitates meta-analyses and improves the evidence base used by physicians to make prescribing decisions. However, it is also vital that these data are accessed and analysed appropriately; as such, we support the transparent development of criteria around access and usage.

The Institute is currently developing a more detailed policy relating to transparency and publication, and will make a formal announcement shortly. If you would like to contribute to the development of ICR policy in this area, please contact policy@icr-global.org.

Reference
1 European Medicines Agency (2012): “European regulators propose way forward for publication of full clinical-trial data”, available via www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/04/news_detail_001486.jsp
Source
ICR announcement
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