Thoughts on Global Medical Affairs
As evidence, did you see this article in the NEJM? It’s a research analysis in which they pulled the entire ClinicalTrials.gov database and analyzed it to determine who has been publishing summarized clinical trials results as required by FDAAA from 2007. This analysis was done by cardiologists at Duke, and what got the headlines was that only 38% of completed studies had their data posted as required by the law.
However, dig a little deeper and with more of our focus and you can learn some interesting things about the biopharma industry. Of all the 13,300 (all numbers rough for discussion purposes) completed clinical trials analyzed, 66% were industry sponsored or roughly 8700 trials. Only 5100 of the 13,300 completed clinical trials reported any results, and of 3600 of those 5100 reporting trials, or 71%, were industry trials. So, in a world of terrible compliance, industry was punching above its weight. That still leaves some 5100 industry trials with not results posted despite the law.
BUT, you say, isn’t there some exception for holding back results until after FDA approval/rejection. Yes, a company can file a certificate which allows it to delay posting results in that circumstances. Of the 5100 completed industry trials missing data only 2000 certificates were filed – leaving 3100 or 36% of all industry trials unreported or uncertified per the law.
This is where big data and company reputation risk raises its ugly head. There are big data sources already out there that read all the data from ClinicalTrials.gov. With today’s big data tools it is a straight forward exercise to determine which industry company sponsored which trial and whether it reported/certified per the law. They will also know which products have failed to report/certify if the products are approved. It is not long from now that some reporter will put this together and produce a list of the “best and worst biopharma companies for publishing results” – some uncharitable media outlets (and which ones are charitable to biopharma) may even imply sinister intent at “denying their legal obligation to share this data – what are they hiding.”
Implications for Medical Affairs and Clinical Development
There is a unique opportunity to head this potential distraction off at the pass. We don’t want our MA field team’s spending time justifying why the company is not posting data.
While maintaining ClinicalTrials.gov is generally the responsibility of the CD in most organizations, MA has a strong vested interest to ensuring that the company is bullet proof in this area. MA and CD need to collaborate to make sure that data is posted or the certificates are filed. A process audit to confirm that the processes are in place and are working, as well as verifying that the company does not have any missing posting or filings, is a small bit of work that can save a huge amount of distraction for the entire organization in the future.
What has been your experience in this area? Leave a comment