About four years ago, the FDA and pharma industry execs laid out controversial new rules mandating the public disclosure of clinical trial results, moving aggressively after the public learned that some devastating drug safety data had never seen the light of day. But today, investigators conclude, the data reporting system has left large chunks of data in the dark, with a loose and relatively haphazard collection of clinical trial outcomes available to the general public. And new studies in the British Medical Journal conclude that unreported or inadequate disclosures have created a potentially harmful situation for patients.
"The current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine," write Richard Lehman from Britain's Oxford University and the BMJ's clinical epidemiology editor Elizabeth Loder. "Missing data is a serious problem in clinical research," the scientists concluded, according to a Reuters report. "It distorts the scientific record, so that clinical decisions cannot be based on the best evidence."
The BMJ is one of a number of journals to take developers to task on their data reporting practices. But despite the new mandates, there's no evidence that the pharma industry is drawing any closer to achieving true transparency. The BMJ concludes that some developers are purposefully keeping some data under lock and key, or publishing it on obscure sites. They want an end to what they call a "culture of haphazard publication and incomplete data disclosure."
- read the story from Reuters
- here's the report from the Daily Mail