Back in July when Dr. Scott Gottlieb made a speech before the American Medical Association and made a lengthy reference to a November workshop in which FDA would participate regarding adaptive clinical trials, there was a great deal of anticipation generated.
Here at this blog, many emails and inquiries were received on a daily basis regarding this workshop. People and organizations from the U.S. and outside the U.S. were hungry to know when and where it would be and how to register. And, in earlier postings, also through emails, I was able to get and post information here about the content of the workshop.
This workshop is extremely important because, as FDA has made apparent, adaptive clinical trials are key to the future of personalized medicine and to the FDA’s Critical Path Initiative.
But the concept of this workshop means more than the future development of therapies – it is also an opportunity for FDA to demonstrate its leadership. Leadership has, for the duration of this Administration, been largely elusive and the agency has in many quarters been branded as a follower, rather than a leader. It is standard operating procedure that when you have lost credibility, you seek opportunities to demonstrate otherwise.
But, in this respect, it would appear that leadership on this issue, has been largely abdicated to PhRMA which is apparently the organization staging the event, rather than the FDA.
A call to PhRMA to inquire made to the person in charge of the event went unanswered. On the PhRMA Website, there is no press release regarding the Adaptive Clinical Trials Workshop, being held in North Bethesda on November 13-14. Nor is there a registration notice nor an electronic means to register. Likewise, the FDA Web Site offers no clue as to how to register for the workshop.
For some reason, it has been a well kept secret. While an article sent by an Eye on FDA reader, inferred that the workshop would be private, there have been rumors and counter emails from other readers that it has been opened up. Not only that, but on top of that there is also now already allegedly a waiting list.
That leaves an important question. How did a waiting list materialize if there is no registration process put forth by either the organizing entity or the federal agency which is the greatest stakeholder? What is going on with this workshop?
There has been a tremendous demand on the FDA and the drug approval process to become more transparent. This is evidenced not only in the recent IOM report, but from many quarters. This workshop provided a tremendous opportunity to move the FDA image forward. Instead of seizing the day, what we have is a text book example of what not to do when such an opportunity presents itself. And the mystery continues.