Program Builds Better Clinical Researchers

When Dr. Doug Shaffer headed to Kenya for a year in 2001, his hope was to have a lasting impact on future research and human subjects protection in his role as director of clinical research for the Indiana University-Moi University College of Health Sciences. While in Africa, he wrote a letter to Clinical Center director Dr. John Gallin. "I see more poverty, death and suffering than at times is bearable, but a day does not go by where I am not thankful for the opportunity to be here."

In the same correspondence, Shaffer, the first NIH graduate of the NIH-Duke Training Program in Clinical Research, continued, "If my research career ended today, I want you to know that one of the more remarkable benefits with far-reaching impact which the training program in clinical research may have will come to fruition here in Kenya."

Shaffer entered the NIH-Duke program at its inception in 1998. Then a second-year clinical fellow with NHLBI, he credits the program with his career advancement.

The program, a partnership between the Clinical Center and Duke University Medical Center, offers NIH physician-scientists formal academic training in the quantitative and methodological principles of clinical research. Graduates receive a master of health sciences in clinical research, a professional degree awarded by Duke; there is also a non-degree option for qualified students who want to pursue specific areas of interest. The Duke program, established in 1986, is one of the nation's first training programs in clinical research. NIH's collaboration with Duke is the first time that the program was made available for long-distance learners. NIH students attend classes via videoconferencing in the CC.

Since 1998, 105 students from 15 NIH institutes and centers have entered the training program. Of those, 34 have graduated and 44 remain active in the program. At least one institute, NIDDK, has developed a mentored clinical research training program with the NIH-Duke program at its core.

For NIDDK investigators Dr. Jeffrey Kopp and Dr. Kristina Rother, the program is an opportunity to learn how to do better clinical research.

NIDDK pediatric endocrinologist Dr. Kristina Rother studies ways to help people with type 1 diabetes.

Kopp conducts basic research on the mechanisms of focal segmental glomerulosclerosis (a scarring kidney disease) and treats patients on related research protocols. His team is studying new ways to use old medications and is working to develop new treatments for focal sclerosis. Although he's been doing clinical research for a while, he wanted to be better informed and trained. "I wanted to improve my clinical research skills. I'm also a mentor and knew the program would help me be a stronger one. The courses give extensive in-depth formal theory and practice instruction. You are taught to ask the right questions, get the right research subjects, how to do research ethically and obtain a clinically useful result," he said.

Rother is a pediatric endocrinologist. As a senior staff clinical investigator, she's researching ways to help people with type 1 diabetes. She works with children to keep their insulin-producing cells alive in hopes of giving the children healthier, longer lives. Her basic research training was solid with regard to laboratory science but she did not have much experience in applied clinical research.

"Like many things in life, as a self-taught person you're proud of your accomplishments but you do not have a firm basis. The NIH-Duke program makes you think in a wider horizon by teaching new ways of achieving your goals or finding out what you need to know about a specific condition. You learn about many alternative approaches," said Rother. She spoke of the informed consent form. "You typically don't have the luxury of discussing in depth practical, ethical, philosophical and other aspects of the consent form and process. But this training program makes you think — what about kids, prisoners, soldiers — you learn about all the considerations."

Pediatric nephrology research fellow Mari Hayakawa (l) and PHS Commander Jeffrey Kopp review an autoradiograph report in an NIDDK laboratory.

The NIH-Duke program enables clinical investigators to conduct state-of-the-art clinical research. That, according to Dr. Louis Simchowitz, director, Office of Fellow Recruitment and Career Development, NIDDK, is the overall value of the program. "The knowledge gained from the didactic course work and the clinical research project are invaluable in developing the credentials of the next generation of physician-scientists in medical schools and academic health centers. The program is emblematic of the future training and career development pathway for those who will lead the way in cutting-edge translational and patient-oriented research."

Applications for the 2005-2006 academic year are available through the CC Office of Clinical Research Training and Medical Education (Bldg. 10, Rm. B1L403) and must be submitted by Mar. 1. For more information call (301) 496-9425.