Oncology researcher Dr. Vinay Prasad says he often feels frustrated conducting studies comparing the optimal use of marginally beneficial but expensive cancer drugs. Prasad, based in Washington, D.C., often runs into roadblocks when he makes information requests to drug manufacturers about studies they have conducted or funded.
“Medical science has been hijacked by commercial interests and proponents of new things,” said Prasad, who was so passionate during an interview about the issue that he was nearly yelling into the telephone. “You consistently get either no answer or an excuse.”
Prasad is not alone in his frustration. Data from many clinical trials remain unpublished and unreported long after the investigations are completed. Drug companies often cite the need to protect confidential business information.
Of 182,330 clinical trials and observational studies listed on the website maintained by the National Library of Medicine and the National Institutes of Health, ClinicalTrials.gov, only 15,899 have posted results.
When researchers from the Cochrane Collaboration, which provides systematic research reviews, looked for data on the safety and effectiveness of various treatments for flu symptoms, they said it took 4½ years to obtain the complete list of trials conducted by manufacturers.
Last week, the Institute of Medicine urged major changes in data-sharing practices to make it easier for independent researchers to compare therapies.
Some experts have hailed the report—Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk—as a big step toward greater research transparency.
In presenting the report, IOM leaders recognized stakeholders' hesitancy to share research, but urged the adoption of policies to guide the registration and release of study results, particularly for NIH-funded trials.
“Responsible sharing of clinical trial data will advance the science that underlines the clinical foundation of good care,” said Dr. Bernard Lo, chair of the IOM Committee on Strategies for Responsible Sharing of Clinical Trial Data.