One might ask oneself why, if an important conference in which there is a high level of interest is just a few weeks away, have details not been announced. The answer may be that most of us assumed that the conference was open. It may be private.
A very kind reader sent me an article from BIO-IT that interviews Robert Powell, senior pharmacist at FDA’s Office of Clinical Pharmacology and Biopharmaceutics at CDER. In the context of the article, the adaptive clinical trials workshop is referred to as a "private conference."
That is the bad news for those who were interested in attending the conference who are not invited. The good news, I suppose, is that for those many who are interested, the FDA is working on five guidances related to adaptive clinical trial design.
If this is so, the FDA and PhRMA have done a poor job communicating about the conference and about adaptive clinical trial design. In his speech in July, Dr. Scott Gottlieb stated that the FDA would be participating in the conference, but said nothing about it being a private workshop. He also stated that the "we have also established special teams to provide consults to divisions contemplating an adaptive trial design." Does anyone know who the teams are? Does anyone know how to contact them? Is anyone receiving counsel from them?
For those who wanted to attend the conference, at this late date, to confirm the private nature of it, one may wish to contact PhRMA directly.
