When the European Medicines Agency (EMA) released its draft policy on clinical trial data disclosure in June, it expected a big response. And it got one, with more than 1,000 comments submitted in the four-month consultation period. Working through this feedback is taking a little longer than expected though.
Regulatory officials planned to finalize the policy by the end of the year, but this week warned they may push back timelines. The news comes as the EMA tries to work through the sackload of feedback that its controversial trial data transparency policy provoked. EMA's plans to make clinical trial data available to researchers once a drug is approved have put it on a collision course with the biopharma industry, sections of which are strongly opposed to the policy.
EMA staffers are currently working through this feedback, and the regulator now expects to spend longer than initially anticipated in this policy review phase. An update on timelines is expected after an EMA management meeting in mid-December. While the go-live date for the finalized policy is increasingly uncertain, there is no indication the plan itself is in jeopardy. In its release warning of the potential delay, EMA reiterated its belief in the need for transparency to increase trust in biopharma and spur innovation.
The latter point has proved contentious, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) warning that the EMA plans will weaken the incentive for biopharma to invest in R&D. In response, EMA leaders outlined how they believe transparency will lead to data-driven improvements in the running of clinical trials and other efficiency gains. So far, it seems EMA is sticking to its guns.
- read the EMA release
- here's Pharmalot's take
- view the EFPIA objections (PDF)
- and EMA's response
Industry Voices: Clinical trial transparency--time for some carrot as well as more stick?