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When a child in a gene therapy trial developed an illness similar to leukemia last fall, the U.S. Food & Drug Administration put a “clinical hold” on other attempts to treat a severe immune deficiency with the corrective gene. Dr. Ananda P. Dasanayake quickly took note. He lectures on the meaning of clinical holds and dozens of other FDA initiatives to students in the Master of Science Degree Program in Clinical Research. A clinical hold suspends a trial until safety concerns are addressed. Although the leukemia-like disease temporarily halted gene therapy experiments, an FDA advisory panel subsequently recommended continuing the trials with new restrictions and protections, such as clearly informing subjects of the risk of cancer. The panel felt that one adverse event did not warrant halting all testing, noting that gene therapy apparently succeeded in curing other patients, and that the risk of cancer so far appeared to be modest. But Dr. Dasanayake says researchers in other cases haven’t fared as well with the FDA. “Promising research careers can be destroyed because the investigators don’t understand FDA and other regulatory agency rules,” he says. “Our program teaches researchers how to flourish within those guidelines.” “For example, we show researchers how to design a better trial by understanding the nuances of FDA language,” adds Dr. Sylvia Most, a faculty member and former Vice President of Regulatory Affairs in a leading pharmaceutical company. “Researchers who know the difference between ‘should’ and ‘shall’ in FDA regulations will be better able to assess the kinds of things they can and cannot do in a trial. Rules that say ‘should’ are advisory; those that say ‘shall’ are mandatory.” Students in the clinical research program get a first-hand look at the do’s and dont’s of scientific investigation by involving themselves in real-life trials in the new Bluestone Center for Clinical Research. They attend institutional review board meetings; write grants, protocols, and journal manuscripts; and perform statistical analyses and other critical tasks. The program was established in 2001 to help address a shortage of trained clinical researchers in all health fields. The demand for clinical researchers continues to grow, with industry-sponsored trials expected to employ 56,000 principal investigators in 2005, up from 33,000 in 2000, according to CenterWatch, a clinical research newsletter. Thousands more will be needed for government, academic, and other nonprofit-sponsored research. NYUCD’s Clinical Research Program prepares students for careers as clinical researchers in any health field. “Although we have a responsibility to help meet the acute need for oral health researchers, we also want our students to be able to take advantage of the wide range of other career options available to them,” says Dr. Dasanayake. “Few programs provide such broad-based training.” Bernal Stewart, an oral health researcher with Colgate-Palmolive who is a first-year M.S. degree student, values the chance to collaborate with students across a broad spectrum of disciplines. “Putting together a successful trial depends on understanding what other researchers have already accomplished,” says Stewart, who tests toothpaste, whitening agents, and other consumer products. “Working with other students teaches me how to analyze different research approaches.” The program has been designed for a diverse mix of individ-uals from academia and industry in nursing, medicine, dentistry, pharmacy, and other allied health professions. Stewart, who studied computer science as an undergraduate, became interested in clinical research because of his knowledge of statistics and data processing. Another student, Dr. Yves Jean, was a scientist in an agricultural products company. The other master’s degree candidates want to combine clinical research training with certification in various dental specialties. “It’s much easier to explain complex scientific advances when you have a sound knowledge of research practice,” says Dr. Ryan J. McCafferty, who is enrolled in the M.S. program and is pursuing postdoctoral endodontics training in preparation for an academic career while on leave from the United States Navy. As the program moves forward, Dr. Dasanayake says he expects to attract a broader range of health professionals and industry scientists with a convenient schedule of classes taught by faculty and guest lecturers from NYUCD, the NYU School of Medicine, and leading corporations, contract research organizations, and regulatory agencies. “Most of our classes are held in the evening, and we provide the options of a one-year certificate program and a one-year fellowship, as well as the two-year master’s degree program,” he notes. While space in the M.S. program is limited to six students, Dr. Dasanayake expects enrollment in the certificate program to grow exponentially. “We teach practical matters, such as how to design a trial, where to seek funding, and how to recruit subjects,” says Dr. Ralph V. Katz, Chairman of the Department of Epidemiology & Health Promotion, who co-designed the program with Dean Michael Alfano. “But beyond that, we also deal with profound issues, such as the ethical responsibilities involved in research on human beings. We train our graduates to take a wide view of their impact on the world.” |
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