WIKIMEDIA, JOHANNES JANSSON/NORDEN.ORGIn recent years, advocates for consumers and transparency have been pushing regulatory agencies, journals, and clinical study sponsors to make human experimental data more accessible to independent scrutiny. In an attempt to balance the opposing forces of transparency and intellectual property, the Institute of Medicine (IOM) yesterday (January 14) laid out its guidance for when drug developers should share certain elements of clinical trials, including the protocol, summary results, and full dataset.
“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,” Harlan Krumholz, a Yale University cardiologist who also heads the Yale Open Data Access project, told the The Wall Street Journal’s Pharmalot.
Specifically, the report’s authors recommend that 12 months after a trial has ended the summary results should be shared with independent investigators. Then, six months after that, the full dataset—including all the results, the full protocol, and the analyses—are to be made available. According to a summary of the report, “when that period has passed—regardless of whether the trial results have been published—the IOM committee finds that the scientific process is best serviced by allowing other investigators to access the data.”
Some advocates of data sharing say the recommendations don’t go far enough to include past clinical trials, and that they allow for companies to keep confidential information secret. “Like most proposals, the devil is in the details,” Diane Zuckerman, president of the National Center for Health Research, told Modern Healthcare. “Based on the track record of companies and government regulators, essential information that no reasonable person would think is a trade secret is often redacted as trade secrets.”
Modern Healthcare pointed out that while the recommendations are supported by various health agencies and regulators as well as pharmaceutical companies, there’s no guarantee they will be implemented.