Statsols Blog

Institute of Medicine releases report “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk”

Great BLOG Post from By ED SILVERMAN on the Wall Street Journal

In response to ongoing debate over access to clinical trial data, the Institute of Medicine has released a widely anticipated report that recommends government agencies and companies share data from research studies that they fund.

The report sets out several steps that clinical trial sponsors are encouraged to take in order to widen access. These include developing specific plans for sharing data, such as granting access through third-party web sites; and adopting recommended timetables for releasing both summary and complete data packages after studies have been finished and published.

Specifically, the IOM suggests that summary level results, including adverse event information, should be publicly available no later than one year after a trial has been completed. And a complete data package, which includes the full protocol and statistical analysis plan, among other things, should be shared no later than 18 months after a study is completed.

“The issue is no longer whether to share clinical trial data, but what specific data to share, at what time and under what conditions,” according to Bernard Lo, who chaired the IOM committee that generated the 249-page report.

“Our recommendations represent an attempt to balance the interests of different stakeholders with the public interest of having the best information possible regarding the effectiveness and safety of therapies,” writes Lo, who is president of the Greenwall Foundation, an independent organization that supports bioethics research.

At issue is the ability for researchers to independently verify study results and, consequently, improve patient treatments that can lead to better care and lower costs. Concerns over access have accelerated in recent years in light of various safety scandals that revealed data for some products were never fully published or disclosed. Often, the information emerged as a result of litigation.

For their part, drug and device makers have argued that releasing data – notably, patient-level data – can allow trade secrets to circulate; may compromise patient privacy; undermines trust in the regulatory system; increases the risk data would be misinterpreted; and lessens incentives for research. For these reasons, some companies have been reluctant to grant much, if any access, although others have taken steps to do so.

The controversy has prompted an increased push to release data. But responses from government and industry have been inconsistent and, significantly, lacking an overall framework in which to proceed. The IOM report, which was developed in response to requests from nearly two dozen public agencies and companies, is viewed as a notable step toward remedying the controversy.

“The report adds a welcome endorsement from the medical establishment that data sharing is not optional and the move toward open science in medical research is not a fad,” says Harlan Krumholz, a Yale University cardiologist who also heads the Yale Open Data Access project, which works with drug and device makers on providing trial data access. “There is little question now that the current approach, in which the results of studies of people are too often not reported and the data even less often shared, harms the integrity and trustworthiness of medical evidence.”

But Carl Heneghan, who heads the Centre for Evidenced Based Medicine at Oxford University and co-founded the AllTrials campaign that pushes drug makers to release data, complains some IOM recommendations are “disappointingly weak. Providing metrics which are actionable, accessible and auditable is the key to effective data sharing.” He thinks trial sponsors should be required to regularly audit compliance with data sharing.

“While the report does not endorse the status quo, it focuses almost exclusively on practices related to future clinical trials, stating that sharing data from past trials will occur on a case-by-cases basis,” says Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland and a BMJ associate editor. “I think that’s a bit too generous, given that policy and practice is heavily shaped by past trials, which remain hidden.” He also notes there are no details on trade secrets.

A spokeswoman for the Pharmaceutical Research & Manufacturers of America says the trade group “supports the IOM efforts to identify strategies” for sharing data and will read the report. She also pointed to a set of principles issued two years ago in conjunction with the European Federation of Pharmaceutical Industries Associations, although these fell short of what some researchers have sought. A spokeswoman for BIO says the trade group supports data sharing but has not had a chance to read the IOM report and so there was no specific comment.

To what extent the IOM recommendations will be actually adopted remains to be seen. But the report arrives amid tentative signs of change. After reaching a $3 billion settlement with U.S. authorities for various infractions, including withholding trial data, GlaxoSmithKline launched an effort for posting trial data and has begun to grant requests for access by researchers, which are decided by a panel. Several other drug makers have since joined the project.

Separately, Johnson & Johnson has reached two agreements with the Yale Open Data Access Project to make trial data available. Last year, the health care giant agreed to provide access to data about its medicines and today, the arrangement was broadened to include medical devices and diagnostics. However, only trial data generated as of 2014 will be available.

Meanwhile, the U.S. Department of Health & Human Services recently proposed new rules to clarify requirements for researchers to post findings on a federal repository known as And in a few instances, the NIH has “strongly encouraged“ institutions that receive agency funds for studies to make trial data available to the NIH. Agency officials recently wrote a JAMA article endorsing data sharing.

Separately, the European Medicines Agency recently issued a new access policy, although the European Ombudman has questioned whether this was watered down after the regulator settled litigation with AbbVie, which went to court to block the release of some trial data. A key point of contention was the extent to which the agency may release confidential commercial information. For more information CLICK HERE

Topics: Uncategorized