Meta-science

Now is the time for transparency and access to clinical-trial data

Originally at https://metascience.shaunagm.net/post/37407457013/now-is-the-time-for-transparency-and-access-to-clinical-trial-data

From this post:

The lack of access to clinical data has harmed patients, led to additional cost, and is preventing progress in many therapeutic areas.  Rofecoxib, a non-steroidal anti-inflammatory drug, marketed by Merck & Co. is a prime example. Research published in JAMA demonstrated that two pivotal publications of industry-sponsored clinical trials of rofecoxib for Alzheimer’s disease did not include analyses of mortality, enabling the studies to conclude rofecoxib is “well tolerated.” In direct contrast, and at the same time as publication, Merck’s internal intention-to-treat analyses from the same trials identified a significant increase in total mortality. What is striking about this case is these mortality analyses were neither provided to regulators nor made public.