In the Senator’s article published last week in the New England Journal of Medicine, Elizabeth Warren commented, “Data sharing holds incredible promise for strengthening the practice of medical research and the integrity of our clinical trial system.”
Warren specifically lauded the International Committee of Medical Journal Editors’ (ICMJE) recent work in developing a framework for data sharing – a proposal which was published in January 2016.
As Outsourcing-Pharma.com reported at the time, the proposal recommends that data sharing be mandated before manuscript publication is considered.
However, as Warren notes in her perspective, there are “many policy, privacy, and practical issues that need to be addressed in order to make data sharing practical and useful for the research community.”
In its perspective, published the same day, The International Consortium of Investigators for Fairness in Trial Data Sharing, explained that before a data-sharing policy is passed, the ICMJE, trialists, and other stakeholders must “discuss the potential benefits, risks, and opportunity costs, as well as whether the same goals can be achieved by simpler means.”
The Consortium said that while there are potential benefits to data sharing, such as “occasional new discoveries,” there are also risks, such as “misleading or inaccurate analyses and analyses aimed at unfairly discrediting or undermining the original publication.”
It also cited “opportunity costs,” explaining that ICMJE’s proposal would “probably divert resources, both financial and human, from the actual conduct of trials.”
As such, the consortium recommended several modifications to the proposal, including changes to timelines, and confirmatory analyses before publication of an article via an independent statistician.
It also recommended that those not involved in an investigator-initiated trial, but who want access to the data “should financially compensate the original investigators for their efforts and investments in the trial and the costs of making the data available.”
In reviewing the perspectives, Darren Taichman, Executive Deputy Editor, Annals of Internal Medicine, Vice President, American College of Physicians, told Outsourcing-Pharma.com that “fostering an environment for the fair and safe sharing of clinical trial data is complex, as is discussed in this recent set of thoughtful and constructive perspectives papers.
“Many of the important issues noted, and others, are raised in the comments received by the International Committee of Medical Journal Editors [ICMJE] in response to our request for feedback on our data sharing proposal,” he added.
The response for feedback on the ICMJE’s proposal closed on April 18, 2016. Comments are open on both Toward Fairness in Data Sharing, and Strengthening Research through Data Sharing through Wednesday, August 10th.
Taichman further explained that the ICMJE is carefully studying the issues posed in the perspective papers as the Committee works to pursue policies that will achieve a common goal: “improving care by maximizing the knowledge gained from clinical trial participants’ generous efforts.”
The Association of Clinical Research Organizations (ACRO) is advocating for updates to HIPAA, which would enable greater data sharing across the healthcare system to help advance research.
“ACRO believes all federally funded - i.e. taxpayer funded - research should be shared,” John J. Lewis, Senior Vice President, Policy & Public Affairs, ACRO told us, although he did not comment directly on Senator Warren's article.
Title: Strengthening Research through Data Sharing
Author: Elizabeth Warren, J.D.
Publication: N Engl J Med 2016; 375:401-403
Date: August 4, 2016
Title: Toward Fairness in Data Sharing
Author: The International Consortium of Investigators for Fairness in Trial Data Sharing
Publication: N Engl J Med 2016; 375:405-407
Date: August 4, 2016