CC Sabbatical Program Open to More Applications

Episode # 51
Uploaded: December 27, 2010
Running Time: 8:48

SCHMALFELDT: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO.

The National Institutes of Health Clinical Center is accepting inquiries and applications for a sabbatical program in clinical research management. After a successful pilot, during which four experienced clinical and translational researchers completed their sabbaticals, the Clinical Center seeks additional applicants for this program which aims to augment the knowledge base of its participants with content that meant to enhance their previous skill sets with the ultimate goal of enhancing their abilities to expertly manage a clinical or translational research enterprise and to create and institutional infrastructure promoting safe, ethical, and efficient patient-oriented research. The program launched in 2009, is accepting a limited number of applicants who are experienced in the world of clinical or translational research but want to learn more about management of a clinical research enterprise. The participants in the sabbatical program will choose an individualized set of electives and receive focused attention from managers, executives, and clinician-scientists. The elective leaders are mainly from the Clinical Center, but other educational partners providing elective leaders include other NIH institutes and centers, the US Food and Drug Administration (FDA), the HHS Office for Human Research Protections, and the Foundation for the NIH. Dr. Fredrick P. Ognibene, the Clinical Center's Deputy Director for Educational Affairs and Strategic Partnerships and director of the Office of Clinical Research Training and Medical Education explained the concept.

OGNIBENE: The goal of this program is to actually work with both investigators and administrators who have an understanding of the clinical research enterprise but would like to have additional help in certain areas—perhaps to gain expertise, realizing that we as a model in the Clinical Center, as a clinical research environment, have everything from A to Z. So in developing the program we conceptualized it as being based on different modular areas which cover the range, from patient recruitment to issues related to the ethics of clinical research, dealing with budgets, regulatory issues, and such. And in that context the applicant to the program, once accepted, works with my staff and we tailor-make the program based on what they find most important to their goals and objectives, focusing on things that they may not know or things they may want to know better than they already know.

SCHMALFELDT: Clinical Center Director Dr. John I. Gallin said the NIH Clinical Center is the perfect location for such a program.

GALLIN: There are certain advantages to the location of the Clinical Center. Namely that it's in the federal government and it is central to a whole variety of components of the clinical research regulatory process. It's very close to the Secretary of the Department of Health and Human Services and her office, in particular the Office of Human Research Protection. It's very close to the Food and Drug Administration and it's close to all of the institutes at NIH. Part of the objective of this program is to demystify these federal regulatory entities, and to make it possible and easy for people to understand how to interact with them and make local programs more effective.

SCHMALFELDT: One of the original four participants in the program is Dr. Giselle Sholler. She is the Assistant Professor of Pediatrics, Division of Pediatric Hematology/Oncology at the University of Vermont.

SHOLLER: I met with Dr. Rosenblum quite a few times from the CTSA program and he has been really instrumental, and some of the things that we've worked on involve data management and collection and he has told me about the red cap program, and we are actually, back at the university of Vermont, we are a member of the red cap, and so we are going to use that now in our consortium. One of the other electives I did was the strategic planning and budgeting, I learned about all of the strategic planning and budgeting for the Clinical Center and that was really helpful to see how the process was done here and how we can potentially mimic that in our consortium.

SCHMALFELDT: She expressed her gratitude to the Clinical Center for establishing this program.

SHOLLER: I just want to you know thank you guys for having this program available to us from the outside. I mean it's an incredible resource to help our programs grow in clinical trial development and to build the collaboration within the pediatric oncology branch and the NCI here, it's just such a resource that will help me going back to the University of Vermont and strengthening our research program there. And I know that I'll continue to work with all the researchers here even once the program is completed. We will continue to collaborate together.

SCHMALFELDT: Dr. Gallin noted how important a program like this is, not only to the NIH and the health care and clinical research community at large, but to the nation.

GALLIN: This is the first program that formally addresses the issue of how do you run a clinical research facility. And it's quite clear that these are becoming very important to not only the NIH but to the country, in the health care reform act, one piece of that legislation was to create something called the Cure Acceleration Network, or CAN. The Cure Acceleration Network is just what you think it is, it's to think of new ways and better ways to take basic science observations into a therapeutic or device. We hope that this sabbatical in clinical research management is one small step that will help to facilitate that objective.

SCHMALFELDT: Dr. Ognibene explained how other interested clinicians can participate in the program.

OGNIBENE: There is an online application, the application is available on the Clinical Center's Office of Clinical Research Training and Medical Education website. Once a person completes the online portion of the application, it is reviewed by a team, and then based on the initial review individuals are invited for an interview either live or via telephone to again get a better understanding of what their expectations are, what their time commitments are, and also having them understand what both our abilities and our limitations are. It is very clear that this is not a degree granting program. We don't provide a stipend for the individual but what we do have are experts in the content that are willing to spend their time to train and educate others so they can use the skills and go back at their home institution.

SCHMALFELDT: If you would like to know more about the NIH Clinical Center's Sabbatical in Clinical Research Management program or would like to submit an application, log on to http://clinicalcenter.nih.gov/training/sabbatical. If you're interested in learning more about any of the 1,500 clinical trials and studies performed here, log on to http://clinicalcenter.nih.gov. From America's Clinical Research Hospital, this has been CLINICAL CENTER RADIO. In Bethesda, Maryland, I'm Bill Schmalfeldt at the National Institutes of Health, an agency of the United States Department of Health and Human Services.

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