EMA May Delay Finalizing Policy For Disclosing Clinical Trial Data

Last June, the European Medicines Agency released a draft proposal of a new policy concerning the release of clinical trial data (see this) and the effort quickly became controversial. Why? The EMA wants to proactively make trial data, which is submitted in connection with marketing approval for a drug, available to researchers once an approval decision has been made. The proposal has endured withering criticism. The European Federation of Pharmaceutical Industries and Associations, the industry trade group, blasted the policy and suggested the approach would weaken safeguards for protecting patient privacy, undermine trust in the regulatory system, increase the risk data would be misinterpreted and weaken incentives for research (back story). Meanwhile, more than 1,000 comments were submitted from patients, physicians, industry representatives, researchers, “transparency campaigners,” academics, public institutions and government regulators. In other words, there has been a cacophony of reactions and this has given the EMA pause. And so, the agency, which hoped to finalize its policy by the end of this year, may postpone that step in order to “conduct the appropriate in-depth analysis required,” according to a statement issued today. The EMA says it expects to spend additional time reviewing its plan and will provide an update after a management board meeting scheduled December 11 and 12. There was no indication that the draft policy will be changed, but the potentia...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs