March 30, 2016

Senator Warren Applauds Medical Journals’ Proposal to Require Sharing of Clinical Trial Data

Full text of the letter (PDF)

Washington, DC- United States Senator Elizabeth Warren today sent a letter to the International Committee of Medical Journal Editors (ICMJE) applauding its proposal for journals to require the sharing of clinical trial data by researchers as a condition of publication. Under ICMJE's proposal, the author of a journal article would be asked to share the deidentified individual-patient data (IPD) that was used to generate the article's results.

In the letter, Senator Warren explains how increased data sharing "provides an avenue for independent confirmation of results, additional research, and further analyses of the data set - raising the bar for academic rigor and integrity and speeding the progress of medical research."

The senator further highlighted how the proposal helps address conflicts of interest, noting, "By ensuring that trial results receive independent scrutiny from outside reviewers, data sharing makes it less likely that industry can buy the results they want. Data transparency is a key step in improving the integrity of our clinical trial system." 

As a means of further strengthening data sharing, Senator Warren asked ICMJE to considers ways its journals can encourage the publication of trials that produce null, inconclusive, or negative results. These studies are less likely to be published, but can provide useful data that "will help to further speed medical progress, uphold the ethical standards of human subjects research, and help to hold industry sponsors accountable."

Read a PDF copy of Senator Warren's letter here.