One step forward for better evidence for healthcare… | Naturally Selected
"Advice to the European Medicines Agency (EMA) on data release from clinical trials, published last week, should ultimately help to improve healthcare but reveals widely divided opinion on exactly how data sharing should happen. The advice documents cover different aspects of clinical data sharing and reuse. Five advisory groups discussed: protecting patient confidentiality, data formats, “rules of engagement” (the process for third parties to obtain the data), good analysis practice, and legal issues. This process followed the EMA’s announcement, in November 2012, to implement a policy on “proactive publication” of data supporting all European drug license applications from 2014. “We are not here to decide if we publish clinical trial data, but how”, was the impressive opening of the November workshop by Guido Rasi, Executive Director of the Agency. Now, the Agency has much evidence and opinion to review as it seeks to define who should have access to what clinical trial data, when, and how they will be allowed analyse it. Around 200 people representing researchers, drug and device industry representatives, regulators, patients, publishers, editors and medical communicators contributed to the advice documents. The EMA’s (on schedule) commitment to implementing its policy to establish “trust and confidence in the system” is a significant achievement although we are likely only near the end of the beginning of long process. Sharing and publication of original research data are important to Faculty of 1000, with F1000Research’s leadership in this domain, as are clinical trials. F1000 (IH) had the privilege of contributing advice to several of the EMA’s documents. The advisory documents cover many issues – too many to comment on point-by-point – but here are a few of the most pertinent.