Updated on 24 April 2014
This is a great step forward and one of the key elements of the new data sharing policy is that members will make available the results of all company-sponsored phase 3 clinical trials and clinical studies of significant medical importance regardless of whether their outcomes are positive or negative. Recently Johnson & Johnson had taken the lead in deciding to share its vast clinical trials data with researchers through Harvard University.
With BIO taking the lead in the US, Asian companies should follow the example of their American counterparts in taking similar steps. After all, it is in Asia that there is stringent opposition to the conduct of clinical trials. Transparency in sharing of clinical trial data will blunt the criticism of activists who unfortunately show something amiss in every trial because of the wrong actions of a few players.
Meanwhile, some good news has come from the US regulator, FDA. In 2013, FDA has approved a record number of 31 orphan drugs for commercial release. According to an analysis by Medicitynews.com, this is a significant jump over the previous highest of 26 approvals in 2011. Orphan drugs are medications aimed at treating rare diseases which may not have huge markets but cost a lot to produce still. FDA changes the clinical trial conditions to provide fast track approvals for such drugs so that they reach patients fast. In the 21 years since the enactment of a legislation to empower FDA to handle orphan drugs differently, the US regulator has so far allowed the premature release of more than 450 drugs to treat various rare disease forms. More than 400 orphan drugs are under trials, mostly in the US and Europe to speed up availability of affordable drugs to treat people who need them desperately.