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MPs told about practical difficulties of full data disclosure

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3200 (Published 16 May 2013) Cite this as: BMJ 2013;346:f3200
  1. Jacqui Wise
  1. 1London

MPs examining the topic of clinical trials and data disclosure heard that there may be operational practicalities in the compulsory publication of clinical study reports and raw patient data.

Kent Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency, told the science and technology select committee that he agreed that all trials should be registered and a summary report published. But he added that publishing more detailed information, such as clinical study reports or raw patient data, was more difficult.

Woods said: “They would need to be carefully scrutinised in detail and may need to be redacted in some places, which could be a very labour intensive process.” He added: “We need to give serious consideration [to] how it can be done so it can be useful and operationally …

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