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BMS to publish full clinical study reports in transparency drive

Partners with Duke University to grant access back to 2008
Bristol-Myers Squibb (BMS) building

Bristol-Myers Squibb (BMS) has committed to making full clinical study reports (CSRs) and anonymised patient-level data from trials dating back to the start of 2008 via a collaboration with Duke University in the US.

The initiative - described as "a great leap forward for open science" - will see the Duke Clinical Research Institute (DCRI) act as a gatekeeper for the trial data, with an independent review panel vetting researchers' requests for access.

The DCRI panel will also review the final manuscripts produced from the data for scientific integrity and consistency with the original proposed work.

BMS has committed to providing protocols, CSRs and patient-level data for drugs approved in the US and Europe after January 2008, as well as information on terminated drug programmes two years after they have been stopped.

BMS' chief scientific officer Francis Cuss said the programme will provide "providing broader, more timely access to important clinical trial information and serves as a catalyst to strengthening public confidence in medicines, advancing science and improving public health."

Johnson & Johnson's Janssen unit is exploring a similar approach with the Yale Open Data Access (YODA) project, with a draft data release policy published last month also suggesting researchers will be able to access complete CSRs and patient-level data.

Meanwhile, GlaxoSmithKline (GSK) also said recently it wants to appoint an independent data custodian to handle data-access requests, including access to full CSRs.

Pressure group AllTrials has been campaigning for access to full CSRs, arguing in a manifesto published last year that they are a fundamental requirement for unbiased, independent evaluation of clinical trials and informed decision-making in healthcare.

AllTrials roundly criticised Pfizer at the end of last year after the US drugmaker committed to make only summaries of CSRs available in its new data-sharing policy.

Meanwhile, a study by researchers at German health technology assessment (HTA) agency IQWiG concluded that summaries of trials made available by pharma companies often lack vital details on the effects and side effects of medicines which feature in the full CSRs.

Article by
Phil Taylor

26th June 2014

From: Research, Regulatory

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