Releasing trial information is “in the public interest” and “maximizes the contributions made by clinical trial participants to scientific knowledge that benefits future patients and society as a whole,” the Institute said in a report published this week.
Full transparency would allow secondary investigators to carry out further analyses and generate new research, it said.
“In several highly publicized cases, independent investigators who have reanalysed the data underlying published results of clinical trials have challenged the published results as invalid or incomplete.” This was the case when the Cochrane Collaboration reviewed Roche’s Tamiflu results in 2014.
Six months to release data
PhRMA (Pharmaceutical Research and Manufacturers of America) told us it supports the Institute of Medicine’s aim of responsible data sharing but it had not read the report at the time of our publication.
It did not comment on the Institute of Medicine (IoM)’s individual recommendations, such as giving drug companies a maximum of 18 months to analyse data before public release.
IoM called for summary-level trial results, including adverse events, to be released within a year of the study, and full data to be shared within six months’ of journal publication.
Uniting stakeholders
Setting “clear expectations” that the data will be shared, and agreeing between different stakeholders on how to do so responsibly is the next challenge, the Institute of Medicine said.
The committee behind the report said it recognised sponsors’ business concerns and called for “appropriate safeguards for intellectual property and commercially confidential information, and protections from invalid secondary analyses.”
But it was firm about the need for drug companies to change their expectations and foster a culture in which data sharing is the norm. CROs and sponsors should “design clinical trials and manage trial data with the expectation that data will be shared” and “adopt common data elements in new clinical trial protocols unless there is a compelling scientific reason not to do so,” said the study.
The Institute tasked sponsors with developing an infrastructure “by which data can be shared” and provide funding to CROs for sharing the data. They should also “include prior data sharing as a measure of impact when deciding about future funding,” it said.
And it’s not only drug companies who have a role to play, according to IoM. Disease advocacy organisations could withhold grants unless sponsor firms agree to data sharing.
The Institute further recommended that regulators work with industry to develop new clinical study report (CSR) templates without commercially confidential information or personally identifiable data, and that institutional review boards (IRBs) give guidance on informed consent for responsible data sharing, and adopt protections for participants.
Open data supporters backed the report, with charity Sense about Science telling Twitter, “This is big news!”