EMA Again Delays Finalizing Policy For Disclosing Clinical Trial Data

Once again, the European Medicines Agency has delayed finalizing a proposal to release clinical trial data, a step that was taken in response to growing concerns that, without access to this underlying information, it can be difficult, if not impossible, for researchers to otherwise verify the safety and effectiveness of prescription drugs. The EMA had hoped to finalize its policy by the end of this year, but last month, the agency postponed that decision in order to “conduct the appropriate in-depth analysis required.” In a statement today, the regulator now says there is a “need for further analysis and clarification of certain aspects” of its proposal and that its publication policy will be discussed and its March 2014 meeting. Despite the ongoing delay, the EMA “reiterates its firm commitment to pursuing the objective of full transparency regard clinical trial data.” Why? “The proactive publication and access to clinical trial data because it believes that the release of data is about establishing trust and confidence,” the EMA says in its statement. However, an EMA spokesman says it is unclear when the proposal will be adopted or implemented. But the EMA proposal has been controversial, because the regulator 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. As the agency sees it, wider availability of data “broadens scientific knowl...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs