by Dr. Bill Gluck, Vice President, Clinical Knowledge
For those of you familiar with Monday Night football, the segment ‘C’mon Man!’ is one that has some applicability to the pharmaceutical industry. In the segment, questionable aspects of the game are called into focus, presenting a definitive perspective that calls out the offender with a hearty ‘C’mon Man!’
As recently reported in the Journal of the American Medical Association, roughly 30% of trial results have not been reported to the government site clinicaltrials.gov (see footnotes 1,2). All trials are required, by law, to post results to that website. 30%.
Clinical trials and scientific research has been a cornerstone of new treatment development. The unspoken rule in academic institutions has always been ‘publish or perish.’ Nowhere is it more important than in the scientific and medical research communities to share and build upon each other’s positive and negative results to address the ongoing advancement of disease and medical conditions. What is going on!? C’mon man!
Clinical trials are one way we can advance our knowledge of how potential medications will work. Study participants subject themselves to the unknown when they participate in studies, all for the benefit of the general public. It was not until 1997 when the Food and Drug Administration Modernization Act of 1997 (FDAMA) that the Department of Health and Human Services (DHHS) through the National Institutes of Health (NIH) the information registry clinicaltrials.gov was initiated; the website went live in 2000. The FDAMA establishes, by law, a registry for all federally and privately funded clinical trials of potential new treatments for serious or life-threatening diseases or conditions. The law also established penalties for non-compliance.(see footnote 3)
But compliance with the law has seemingly not had any impact on the industry as a whole. In today’s environment of distrust of the industry especially with regards to sharing information about side effects of clinical results one would think, or almost assume, that compliance to clinicaltrials.gov would be used as a means to re-build trust and image. It is a shame that we as the public tend to hear about potential safety and effectiveness issues through the court systems.
What is almost incredulous about this situation is that in 2004 clinicaltrials.gov won the Innovations in American Government Awards as the Nation’s preeminent program devoted to recognizing and promoting excellence and creativity in the public sector. The program highlights exemplary models of government innovation and advances efforts to address the Nation’s most pressing public concerns (see footnote 4). In order to address the lack of the industry’s compliance HHS has proposed new rules/regulations to the current requirements (a summary can be found at http://www.nih.gov/news/health/nov2014/od-19.htm).
In a time where general perception is that the government cannot get anything done right, they have hit a home run with a good tool with the right intentions and the good of the public in mind; the industry does not seem to be playing the same game……C’mon man!
- 2012 Jan 3;344:d7292. doi: 10.1136/bmj.d7292.
- 2013 Oct 29;347:f6104. doi: 10.1136/bmj.f6104.
- gov (http://clinicaltrials.gov/)