CardioExchange Archive

Here’s a great idea: a preprint archive for clinical trials.

Taking inspiration from the well-established use of preprint archives in physics, math, and other scholarly areas, Martin Fenner, a cancer researcher, proposes the establishment of a preprint archive for clinical trial research papers.

Fenner points out that “the results of clinical trials are rarely first reported in a peer-reviewed journal, but rather are usually first presented at a conference — in the case of important practice-changing clinical trials, often before an audience of thousands of people.” He writes that “the peer-reviewed paper is usually published months or even years after the conference presentation” and that this publication “is not the first time the medical community learns about the results of a clinical trial, or draws conclusions for their own research or clinical practice.”

It’s probably worth mentioning here that Fenner doesn’t discuss the recently growing trend in which important (and not so important) clinical trials are presented at a meeting and published in a journal simultaneously. In such cases, a preprint archive would not be helpful, but of course, it’s unlikely that simultaneous presentation/publication will ever become a universal practice or eliminate the need for the preprint archive.

Here’s how Fenner envisions the system might work:

The preprints should be uploaded at the time of journal submission, or shortly after the conference presentation. The preprint server should add some structure to the preprints, e.g. linking to both the clinical trials registry (Clinicaltrials.gov, EudraCT, and others) and the published paper. The preprint should fulfill the requirement for reporting results set by the FDA. Articles in the preprint archive should be freely available and should ideally provide the main results as downloadable datasets. The preprint server will only work if medical journals — and ideally the ICMJE — have a clear policy allowing prior publication as preprint.

I hope this idea attracts further attention and discussion. In the meantime, I recommend you read Fenner’s entire post on PLOS Blogs.