- Susan Mayor
A working group convened by the Multiregional Clinical Trials Center at Harvard University has recommended a new approach to ensuring that clinical trial sponsors make participant level data publicly available while protecting against inappropriate use of the data.1
It said that one way to achieve this might be with an independent board that oversaw data requests and use. Anyone using the data would have to follow a scientifically valid analytical plan.
Michelle Mello, professor of law and public health at the Harvard School of Public Health and the report’s lead author, said, “Our experiences with Vioxx [rofecoxib], Avandia [rosiglitazone], and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data.
“The question is: how can we achieve the powerful public health benefits of data sharing while protecting research participants’ privacy, avoiding ‘junk science,’ …