Sharing Individual Patient Data from Clinical Trials — NEJM

Use the link to access the full text article from the New England Journal of Medicine.  "Two years ago, you finished a trial that took 5 years of your life. You'd had an idea for a new indication for a marketed drug. After cajoling the drug maker and pleading with your colleagues around the world, you put together, on a shoestring budget, an active-comparator–controlled trial with more than 1000 patients, with each followed for more than 2 years. The results were positive but not stunning: people with the condition under study now had another option for treatment that was equally effective but a little less toxic than existing therapies. You were able to get the work published in a major medical journal. With the primary work published, you had hoped to analyze the data further and prepare additional reports. But another year has gone by with no more publications. Your data lie dormant, providing no benefit for anyone. You are not the only one in this position; there are many data sets from clinical trials that are either never published or from which only a single report is ever produced. Can these data provide value to others? In October 2013, the Institute of Medicine (IOM) convened a committee to examine the current and future practice of sharing individual patient data gathered in the performance of controlled clinical trials. An interim assessment was issued for public comment in January 2014,1 and the full report and an executive summary are now available. I served as a member of that committee. Here, I will summarize the report's major findings, but this article is not a policy statement from the Journal. We will articulate our policy after we have had a chance to share the report with our readers, editors, and editorial board; we anticipate that the International Committee of Medical Journal Editors will also formulate policy on this matter. We urge you to contact us with your thoughts and concerns by commenting on this Perspective article at NEJM.org ..."