Study: Drug developers routinely--and unethically--leave trial data in the dark

Drug companies routinely herald their concern for patients as the leading reason why they spend billions of dollars on drug research. But a new study questions Big Pharma's real commitment to its ethical obligations to patients when companies routinely neglect to publish the results of clinical trials.

Close to one in three of all the clinical trials done in the U.S. are left in the dark at least four years after the studies have been completed, note scientists in a new issue of the British Medical Journal. And the vast majority of those trials have no data at all which are publicly available.

Leaving data under cover "violates an ethical obligation that investigators have towards study participants," notes Christopher Jones from the Department of Emergency Medicine at the Cooper Medical School of Rowan University in New Jersey, and colleagues, according to a report in The Guardian. They call for additional safeguards "to ensure timely public dissemination of trial data."

The move to gain additional transparency in the biopharma industry has provoked some encouragement from players like GlaxoSmithKline ($GSK) and Roche ($RHHBY) and some sharp resistance from others. A move in Europe to force the public disclosure of data has met with intense opposition, for example.

Jones' study reviewed the outcomes of 589 trials requiring more than 500 volunteers and wrapping before the start of 2009. Of those trials, 171 are still unpublished and there are no results for 133 of those.

- here's the article from The Guardian

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.