Clinical trials are important. They are designed to answer specific questions about biomedical or behavioral interventions (novel drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data. One problem is that the results of trials, including potential side effects on new drugs, are not made available for independent scrutiny.
Over the past few years, different 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. Pharmaceutical companies do not support this, partly due to fears over the loss of “intellectual property.”
As a half-way measure, Institute of Medicine (IOM) has produced guidance for when drug developers should share certain elements of clinical trials, including the protocol, summary results, and the full database of results.
The report recommends 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.
Commenting on the proposals, Harlan Krumholz, a Yale University cardiologist who also heads the Yale Open Data Access project, told the The Wall Street Journal’s Pharmalot: “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.”
However, for Diane Zuckerman, president of the National Center for Health Research: “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,” she told the website Modern Healthcare.
