Sharing data from clinical trials: where we are and what lies ahead -BMJ

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4794 (Published 30 July 2013)Cite this as: BMJ 2013;347:f4794Elizabeth Loder, associate editorAuthor [e-mail] drive to make clinical trial data more accessible has garnered widespread international support, but rearguard actions by the drug industry could delay substantial change. Elizabeth Loder looks at international developments in the sharing of clinical trial dataAlmost a decade ago an Italian scientist, Alessandro Liberati, wrote an impassioned Personal View in the BMJ. He had developed myeloma and needed to decide whether to have a second bone marrow transplant. Among the evidence pertinent to his decision were “four randomised controlled trials, whose results haven’t yet been fully published . . .” “Why,” he asked, “was I forced to make my decision knowing that information was somewhere but not available?” He concluded that “Research results should be easily accessible to people who need to make decisions about their own health.”1 His story put a human face on the harm that can occur when clinical research data are not available.In 2003 the US National Institutes of Health (NIH) published a final statement on sharing of data from research activities it had funded. The statement reaffirmed support for the concept of data sharing, which NIH said was “essential for expedited translation of research results into knowledge, products, ...

Source: PharmaGossip - July 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs