Perhaps the recently anounced appointment of Dr. Francis Cuss as Executive VP and Chief Scientific Officer at Bristol-Meyers offers some hope to those of us who seek accelerated development of anti-PD-1 for metastatic melanoma. Under his predecessor, Dr. Eliott Sigal, the drug advanced slowly towards a Phase III Clinical Trial in spite of its endorsement from the melanoma community.
Unfortunately, that trial has no sites in the US and a design which includes both an old comparator arm (Dacarbazine) and a placebo in both the experimental and comparator arms. I hope that this is not a reflection of the “innovation in … the research operating model, processes and governance” that the corporate press release attributes to Dr. Cuss and his team.
Pharma and its partners, Clinical Research Organizations, talk the talk about “patient engagement” but tend to only walk as far as is required to increase patient enrollment in their trials. Trial design matters too. Inclusion of patient reported outcomes matters too. Open access to all data from all trails matters too. We need a “Patient BILL of Rights for Clinical Trials.”
I have my misgivings about the trial set up as well. I understand the reason behind randomizing, but we don’t have good agents to do it with and therefore crossover should be an option. Accrual may be difficult to achieve with this set up since the chemo agents can be prescribed otherwise. Thankfully, the number of folks getting PD1 I believe is 3-1. It is indeed a promising agent but probably will work best in some type of combination.