Video Text Alternative: Supporting Clinical Trials Research and Building your Research Team by Dr. Ralph Nitkin

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TITLE SLIDE: Supporting Clinical Trials Research and Building your Research Team Ralph Nitkin, Ph.D. National Center for Medical Rehabilitation Research NIH/Eunice Kennedy Shriver National Institute of Child Health and Human Development logo (Edit/camera cut) Dr. Ralph Nitkin on camera.	[MUSIC] Dr. Ralph Nitkin: I’m Ralph Nitkin. I happen to be working at the National Center for Medical Rehabilitation Research, which is one of the parts of NICHD. I'm going to be talking to you a little bit about building your clinical trials research team and getting involved in clinical trials research.
Camera view of Dr. Nitkin.	Dr. Nitkin: A well-designed trial is not just some sort of a dichotomous yes/no proposition, but it should also provide information about the mechanism of action. And regardless of the trial outcome, it should indicate where to go from there, so that whether you are testing a pill, a surgical intervention, a therapeutic treatment, or a medical device, think about, what is the active ingredient in your treatment? How could it be optimized, packaged, and delivered? What would be the appropriate controls or contrast groups? And do those contrast and controls, do they really engage the research subjects as much as the featured treatment arm? What are the appropriate outcome measures, and are these really clinically significant to your patient population? How will the data be analyzed and disseminated? And so these are some of the major issues that are covered in my PowerPoint presentation.
Camera view of Dr. Nitkin.	Dr. Nitkin: Common mistakes? Let me take you through four really quickly. First, it's important to optimize the dose and delivery of your treatment before considering a trial. Second, you have to develop a clear theory of the proposed mechanism of action, which will actually drive the whole clinical trial design. And when I talk about mechanism, it doesn't have to be a pathophysiological mechanism. It could be a behavior or even psychosocial mechanism that drives the subject outcomes. Third, you can never underestimate the potential for recruitment and retention problems.
Camera view of Dr. Nitkin.	Dr. Nitkin: And finally, you should seek adequate statistical and analytical support, especially in the early design phase. Don't hypothesize an unrealistically large treatment effect. Understand the inherent heterogeneity of your patient population. Understand the natural recovery processes and the variability in your outcome measures.
Camera view of Dr. Nitkin.	Dr. Nitkin: Preparing the NIH application forces you to put significant thought into the clinical trial design, the recruitment, adequate training of your personnel, and other logistical details. In addition, some NIH institutes have special requirements with respect to clinical trial applications, especially if they go into larger size budgets. So, for any NIH application, you have to apply to a funding opportunity announcement—an FOA—so make sure the FOA that you're using really does allow for clinical trials and does include the likely target NIH institute.
Camera view of Dr. Nitkin.	Dr. Nitkin: You should try to get yourself some experience in didactic training with other trials, so get involved in an ongoing trial, maybe helping out with subject recruitment, treatment delivery assessment. And then later on, if you are developing a clinical trial application, read up on the current NIH policy and discuss your proposal with the appropriate NIH program staff several months prior to submitting the application. That is our job, to talk to you about this. So, I hope that helps, and I hope you enjoy the PowerPoint presentation.
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