Every Little Bit Helps When It Comes to Alzheimer's Research...

Every little bit helps when it comes to Alzheimer’s research. I’m interested to see how FDA’s recent shift in how the agency will evaluate Alzheimer’s therapies will  plays out. I’d also like to suggest another idea. Almost every trial in Alzheimer’s requires a study partner. And oftentimes they are or can be a family caregiver. Having a family caregiver can facilitate trial enrollment and retention, two things companies would pay dearly for. However, the OIG has done little to clarify that payments from trial sponsors to compensate family caregivers, for what is often a very burdensome 4-6 hours of support almost daily, can be paid for at a fair market value in the way the same sponsor could pay an outside third party to do the same work. 

With already strong IRB protections and strict inclusion/exclusion criteria in place, it is difficult to see why this type of arrangement would present issues for the OIG.  Clinical trial protocols do not allow for a stranger, such as a paid  home health aid, to act as a study partner because strangers or acquaintances can often miss subtle changes in the patient that they are required to record. And strangers can sometimes fluster Alzheimer’s patients. So when both can be solved with a family member, why doesn’t the drug company do so? Why is the same FMV based payment ok for a stranger but not a family member when health professionals are in short supply and the family member is a better choice?

Furthermore, such a clarification could enhance minority enrollment in Alzheimer’s trials, where they are in fact more heavily represented in the population but, once again, not in the trials. 

The OIG recently asked for safe harbor ideas. While there isn’t the need for a full blown safe harbor, a simple common-sense clarification to existing harbors would be immensely useful in clearing away the legal anxieties sponsors face. 

Every little bit helps when it comes to Alzheimer’s research.