How will NIH re-engineer the clinical research enterprise?

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How will NIH re-engineer the clinical research enterprise?

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Well, of course, this is the area where the rubber meets the road. Everybody understands that NIH’s mission is to improve health, and it is so dependent upon our clinical research efforts. Clinical research, as is true of most things, has gotten so much more complex in recent years. We now can propose studying novel, extremely complex interventions that could have been only dreamed of five or ten years ago. As a result, we need to become much more sophisticated in how we do clinical research in general and clinical trials in particular. This has led to a bit of discordance amongst agencies and their respective interpretations of some guidelines and rules, such as the requirements for reporting adverse clinical events, human subjects protections, and privacy and conflict of interest policies for electronic data submission. What this set of initiatives will do is, first, provide a basis to harmonize these guidelines across agencies. It also will provide a more coherent and expanded way t

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