Enhancing Study Site Capacity

More rigorous testing of non-patentable potential drugs

Clinical Translational Science Awards (CTSA;s) have created robust infrastructures to run clinical studies at major Health Care Centers. They have patients and personnel, but limited funding for targeted studies unless supported by a commercial interest. Many studies of nutriceuticals, or complementary agents have been done, but very seldom with adequate numbers to get a well-powered outcome. I suggest that care givers would be grateful to try some of these relatively harmless agents in the hope of something working. The key limiting factor is a dependable research coordinator which might cost about $40k per year. Cognition tests can identify progression in about six months (MCI to AD is about 10%/year as I recall). Formulations of agent a placebo are also a cost. Most supplement manufacturers are reluctant to provide the analytical data needed for an FDA IND, but some are willing. This could have a large impact on both patients and care givers who want to do something to help. There are a lot of promising animal and cell culture studies already done, but there is a great lack of support for the human clinical studies needed.



9 votes
Idea No. 118