Dasanayake, B.D.S., M.P.H., Ph.D., is Associate Professor of Epidemiology
and Health Promotion and Director of the M.S./Certificate Programs
in Clinical Research
your copy of Training Opportunities in Clinical Research(pictured
above), please call 212.998.9631
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.
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.
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.”
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.”
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
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
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.”
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.”
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.
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.
in the M.S. program is limited to six students, Dr. Dasanayake expects
enrollment in the certificate program to grow exponentially.
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.”