Hundreds of you got involved last year when the European Medicine Agency (EMA) opened a consultation on its draft clinical trial data sharing policy. Back then, we welcomed the EMA’s proposals which would have seen clinical study reports published proactively and openly. We now hear that an updated draft of the policy puts this at risk.
The new draft policy would introduce barriers for researchers who want to scrutinise clinical study reports (CSRs), including allowing access to CSRs on screen only and allowing trial sponsors to decide what information to redact. Unfortunately, the policy is not available to share. We are going to write to the EMA’s Director, Professor Guido Rasi, with our concerns and urge him to go back to the good proposals the Agency published last year. We’ll share that letter with you when we can. In the meantime, you can read more about the new policy in the following links:
European drug agency backtracks on plan to give researchers access to clinical trial reports by the German Institute for Quality and Efficiency in Health Care (IQWiG) in BMJ. They discuss the challenges these rules would place on agencies like theirs.
Is the EMA poised to make a major U-turn on its transparency initiative? by Peter Doshi and Tom Jefferson, co-authors of the recent Cochrane review on Tamiflu, in PLOS Blogs.
EMA’s data sharing policy – towards peeping tom based medicine? by Tom Jefferson, Peter Doshi, and Trudo Lemmens in BMJ.
Redacted policy on sharing drug trial data in Europe by Trish Groves and Wim Weber in BMJ:
Yet a great deal of information on the benefits and harms of drugs in current use remains hidden from policymakers, clinicians, and patients. If the new European policies for “proactive” disclosure close the EMA window that has been allowing ad hoc “retroactive” access to older CSRs and data, we will all be even more in the dark when making decisions about current treatments. That is why AllTrials continues to campaign for all clinical trials to be registered and all results reported. The research, advocacy, haggling, and politics must go on.
The European Ombudsman, Emily O’Reilly, is also concerned. She told the EMA that these new provisions “could undermine the fundamental right of public access to documents established by EU law.” Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency.