Last year an article in Outsource-Pharma by Melissa Fassbender (“Study: Pediatric Clinical Trials Are Failing to Inform Science”) revealed that 30 percent of the 599 pediatric trials at Boston Children’s Hospital are unpublished in medical literature. Bracken Data’s Bill Blank discovered that the rate of failure to publish results of 30,000 pediatric clinical trials was 87.5 percent.
In 2016 there were 4,173 pediatric clinical trials with posted results, sharing the processes and the conclusions with the medical community, according to Blank. Still, nearly 41,000 pediatric trials have not published their results.
The issue is apparently not limited to children. According to a 2015 article in The Economist, “Spilling the beans: Failure to publish the results of all clinical trials is skewing medical science” (July 25, 2015), “Some estimates suggest the results of half of clinical trials are never published. These missing data have, over several decades, systematically distorted perceptions of the efficacy of drugs, devices and even surgical procedures. And that misperception has sometimes harmed patients.”
Another study, as reported by Nicola Jones in Nature in December 2013 (“Half of US clinical trials go unpublished: Results are reported more thoroughly in government database than in journals”), added that some published studies “omit some key details.” While the results of most studies are published in government databases, as required by law, the databases lack “longer descriptions of methods and results,” Jones said.
According to Blank, “incomplete, inaccurate, misleading, or delayed reporting of medical research may result in poorly informed decision making and reduce the efficiency and quality of health care.” He is especially concerned about pediatric clinical trials, because children might have a different reaction than adults to new drugs.
Since 2008 US law has required the publishing of results of medical research for drugs approved by the US Food and Drug Administration, including adverse effects, in a database called ClinicalTrials.gov. Noncompliance within a year of trial completion could result in lost grants and fines of as much as $10,000 per day. Still, a report in the New England Journal of Medicine discovered that only 17 percent of clinical trials sponsored by industry, 8.1 percent sponsored by the National Institutes of Health and 5.7 percent of those sponsored by other government agencies and academic institutions reported results on the site after a year. The FDA has never actually fined anyone.
An international campaign called AllTrials aims to force researchers to publish all of their clinical trial data. AllTrials is an international initiative of Ben Goldacre, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense about Science. The AllTrials petition has been signed by 90,028 people and 718 organizations thus far, according to its website.
Last year, the U.S. Department of Health and Human Services (DHHS) issued a rule specifying requirements for registering and reporting clinical trials (Clinical Trials Registration and Results Information Submission, 2016), and the National Institutes of Health (NIH) issued a complementary policy for all NIH-funded studies (National Institutes of Health Policy on the Dissemination of NIH-Funded Clinical Trial Information, 2016). The European Medicines Agency has required drug companies to provide detailed reports about study methodology and results (European Medicines Agency, 2014).
Hopefully, these efforts will give clinicians all the information they need to make appropriate decisions. After all, how can practice be truly “evidence-based” without all of the evidence?
Ilene Schneider is the owner of Schneider the Writer (www.schneiderthewriter.com), a firm that provides communications for health care, high technology and service enterprises. She has edited or written for numerous technical publications, as well as serving as a publicist for various medical, biotechnology and pharmaceutical companies.