The Open Data Movement Runs Aground on FOURIER

BY ANISH KOKA Reanalysis of a trial used to approve a commonly used injectable cholesterol-lowering drug confirms the original analysis by accident. The open-data movement seeks to liberate the massive amount of data generated in running clinical trials from the grasp of the academic medical-pharmaceutical industrial complex that mostly runs the most important trials responsible for bringing novel therapeutics to market. There are only a few elite academic trialist groups capable of running large trials and there’s ample reason to be suspicious about the nexus that has developed between academia and the pharmaceutical companies that shower them with cash to hopefully get a positive study result and pay off the pharmaceutical research investment manifold. The FDA is the major regulator of the whole process, but the expertise required for regulation means that the FDA is frequently comprised of ex-pharma employees or ex-academics. The voluminous data generated in trials is usually owned by the academic group doing the research and is frequently guarded heavily from outsiders who may seek to probe it. Many, of course, believe that the data should be made public for independent third-party review. Discovering discrepancies in a major published trial from the pharma-academic complex would be a boost to those seeking to force trial data to be public, and that is exactly what a group of investigators attempted to do with a major cholesterol-lowering trial publis...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Medical Practice Anish Koka FDA regulations Fourier open data Source Type: blogs