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How to Effectively Budget for Your Clinical Trial

This video presents interviews with experts on minority involvement in clinical trials. These include Dorothy Edwards, PhD, Dawn O. Kleindorfer, M.D., Alexander Dromerick, M.D., Jose G. Romano, M.D., Daniel Woo, M.D., and Kathryn France, R.N., P.H.N., C.C.R.C., C.C.R.A

It's no problem to get program officers and PI's to put in the budget for imaging, or biomarkers, or whatever, but it's darn hard to get people to adequately budget for recruitment efforts. It took on average four separate visits of a coordinator to a person in a hospital room, to get them to tell us whether they were going to participate or not.

No clinical trial budget includes four visits. I do ask many of my coordinators to do follow-ups, and other research related activity in the individual's home, to get rid of the cost and so forth. Paying a coordinator to drive five miles out to somebody's home, is a lot cheaper than having that person paying for a taxi cab and parking, for them to come back in the hospital.

We need to do a better job of budgeting for this, budgeting for transportation for the coordinator. The other thing that I did budget for, but I should have budgeted more was brochures. There's the informed consent, and then there can be a brochure of additional information, and the brochure can be packed with scientific information, data that can help somebody make decisions on it.

But I would probably budget anticipating a rainy day, where you will struggle for recruitment based upon participation rates. Maybe you have to give up a little in some place else in your study design, but that's what it takes to get the people to say yes to be in your study, and to keep saying yes by coming back to the study.