The good proposals in the European Medicines Agency’s (EMA) draft policy on sharing clinical trial data could be at risk.
The EMA has produced a further draft of the policy which would introduce barriers to access to clinical trial data that would make the job of researchers who want to scrutinise it almost impossible.
The policy introduces terms of use which say that researchers can access the data on screen only with printing, sharing or saving of the data forbidden.
It allows the company who supplied the data to the EMA to decide which information to redact so researchers may never know what information is being kept hidden.
The EMA’s draft policy also asks researchers to agree that the companies who produced the trial data can take legal action directly against the researchers if the trial sponsor considers the researchers broke any of the conditions, introducing a new and unpredictable risk of high legal costs into routine academic work.
Legal expert Trudo Lemmens and the EU Ombudsman, researchers who work with clinical trial data Peter Doshi and Tom Jefferson, and Beate Wieseler from IQWiG, the German health technology assessment body, have examined the draft policy and have all expressed concerns.
We and hundreds of you wrote in support of the EMA’s initial policy so we have written to Professor Guido Rasi, Director of the EMA, to urge him to go back to the earlier proposals.
Read our letter on PLOS and BMJ.
Professor Rasi replied on 6th June 2014 but his letter does not leave us in a satisfactory place.
Glenis Willmott, MEP, who led the negotiations on the clinical trial regulation has also written to Professor Rasi expressing her strong concerns and asking him to delay finalising the policy.
We support Mrs Willmott’s call to delay finalising the policy. More soon on how you can help.
We would like to thank T. Jefferson, P. Doshi, T. Lemmens and B. Wieseler for their initial comments on the draft EMA policy.