Bioethics Blogs

Nonpublication of Neurology Trials for Stalled Drugs & the Ironic Nonpublication of Data on those Stalled Drugs

In my experience, peer review greatly improves a manuscript in the vast majority of cases. There are times, however, when peer review improves a manuscript on one less important axis, while impoverishing it in another more important one. This is the case with our recent article in Annals of Neurology.

Briefly, our manuscript created a sample of FDA-approved neurological drugs, as well as a matched sample of neurological drugs that did not receive FDA approval- but instead stalled in development (i.e. a 3 year pause in testing). We then used clinicaltrials.gov to identify trials of drugs in both groups, and determined the proportion of trials that were published for all approved drugs, as well as FDA non-approved drugs. We found- not surprisingly- that trials involving stalled neurological drugs were significantly less likely to publish. What- for us- was the bigger surprise was that the proportion of trials published at 5 years or more after closure was a mere 32% for stalled neurological drugs (56% for licensed). Think about what that means in terms of the volume of information we lose, and the disrespect we show to neurological patients who volunteer their bodies to test drugs that show themselves to be ineffective and/or unsafe.

We shopped the manuscript around numerous places- eventually landing at Annals of Neurology. The paper received glowing reviews. Referee 1: “The research is careful and unbiased and the conclusions sound and impactful.” Referee 2: “This is an excellent and very important paper. It rigorously documents a very important issue in clinical trial conduct and reporting.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.