Transparency in the reporting of results from clinical trials has always been a challenging issue for the pharmaceutical industry. While publicly available information on successes and failures is critical for the effective operation and ongoing growth of the industry as a whole, many companies still appear reluctant to adopt a “prompt and full disclosure” approach. This dilemma was recently highlighted in a new report from the New England Journal of Medicine, which makes it clear that there is still a great deal of progress to be made when it comes to timely and comprehensive reporting on clinical trials.
The paper, published in March of 2015, analyzed the timeliness in reporting of over 13,000 American clinical trials conducted between January 1, 2008 and August 31, 2012. For the reporting of each trial, researchers examined two time points: the 12-month deadline mandated by the Food and Drug Administration Amendments Act and five years after each trial’s completion date.
The findings were not encouraging for anyone hoping to see a strong commitment to transparency and timely reporting. For trials funded by industry, just 17% were reported by the 12-month mark, and 41.5% were reported by the five-year mark. Trials funded by the National Institutes of Health fared even worse, with only 8.1% reported after 12 months and 38.9% after five years.
Critics of these large time gaps between trial completion and trial reporting, and of failure to publish results altogether, can hardly help drawing the conclusion that the dearth of comprehensive and promptly available data is the result of the pharmaceutical industry’s desire to carefully select only positive results for publication, hide negative data, and conceal side effects of new drugs. Many hope that the Pharmaceutical Research and Manufacturers of America’s new set of principles for the conduct of clinical trials and the communication of their results will help to make a difference for this critical industry issue. The standards go into effect June 1, 2015.