EMA Delay Clinical Transparency



Gerald Clarke
11/15/2013

In a surprising move, the European Medicines Agency have announced that they will delay the reveal of their clinical trial transparency guidelines. The sticking point appears to be that there has simply been too much interest.

There has been a focus on the publication of clinical trial data in recent years, as activists both outside and inside the industry have pushed to have pharmaceutical companies reveal data for all trials performed. Their argument is that publication bias in the industry is putting patients’ lives at risk, as without all the relevant information, doctors and patients cannot make informed decisions. They also claim that not publishing the details of a trial is a breach of ethics, as patients entering a clinical trial do so assuming that their experiences will increase the knowledge on a topic.

The campaign led in Europe by organisations such as Sense About Science, AllTrials and high profile individuals such as doctor and author Dr. Ben Goldacre. They have won converts to their cause including: The Wellcome Trust, NICE, IQWIG, The BMA, GSK, Cancer Research UK, The BPS, The Royal Pharmaceutical Society, The Royal Institution as well as over 59,000 people who have signed the AllTrials petition. With such a sweeping change, there has been opposition too and there have been public debates and British Parliamentary Committees on the topic.

With all of these strong feelings it is understandable that the EMA received in excess of 1,000 comments in its consultation phase. As they said on their site

Many of the contributors provided detailed in-depth comments, some of them substantial, some of them technical, including suggestions relating to methodological and technical aspects of the implementation of the policy.

With this large input, the EMA have decided to delay the unveiling of their guidelines and have not set a new date. They have stated that they will update timelines on the guidelines next month. The guidelines were also expected to come into use in January 2014, however that also seems unlikely.

While somewhat a disappointment for those pushing for reform, it is potentially a positive thing that so many have offered their advice on the topic and all parties would prefer a considered approach to the topic over a rushed one.

In my first articleon this topic back in May, I said “the issue… is set to rumble on”. Indeed it will.