Art of Clinical Investigation Resuscitated
By Mike Field

Ten years ago, Laura Cheever was a medical anthropology major,
determined to pursue her interest in human health by going on to
medical school. She also had a good idea of what she wanted to do
after that: conduct research that would turn the latest medical
discoveries into bedside clinical care that would directly
benefit patients everywhere. 
     Dr. Cheever remembers vividly making those early plans known
to friends and advisers. Without exception, every one of them had
the same reaction: they were aghast.
     "At that time everyone believed that doctors either worked
in the community practicing medicine or they did academic
research, which was basic science, the kind of research you do at
a bench in the lab," said Dr. Cheever, now a fellow in the
Division of Infectious Diseases at the School of Medicine. "It
wasn't that they just did not encourage me to pursue clinical
research; rather, they warned me that it would be the ruin of my
career."
     Opinions have changed considerably in 10 years. As a
participant in the university's new Graduate Training Program in
Clinical Investigation, Dr. Cheever is among a handful of medical
doctors receiving the first formal, structured training in
clinical investigation ever offered at an academic health center.
The ground-breaking program, introduced last year, may well
establish a trend in medical schools around the country; six
months ago, Harvard introduced a similar program.
     "Clinical investigators play a vital role in modern medical
science in taking products from the bench to the bedside," said
program director and professor of medicine Frank Adkinson. "These
are the people who take the latest innovations and turn them into
useful products."
     Until now, most clinical investigators have learned their
skills in an informal apprenticeship system assisting senior
investigators until they are thought ready to lead a project of
their own. Inevitably, contend critics of the current system,
some of those investigators are ill-prepared for the daunting
task of designing, implementing, monitoring and reporting the
innumerable details of clinical investigations. The result, in
such cases, is bad science.
      Another problem is that  unlike researchers in the basic
sciences, who, to an increasing degree, spend all of their time
in the lab, clinical research practitioners have been forced to
fit their research time in around caring for patients. 
     "Often, the doctors called on to do clinical research have
difficulties balancing their responsibilities as doctors with the
overwhelming complexity of conducting a rigorous clinical study,"
Dr. Adkinson said. "There's nationwide concern about this."
     Dr. Adkinson said about 10 years ago researchers and funding
organizations began talking about the need for some sort of
formal training program in clinical investigation. 
     "Clinical research has become much more demanding and the
level of scientific rigor needed is drastically more stringent
than 25 years ago," he said. "There is a concern that we are
facing a critical shortage of trained, capable clinical
investigators, in academia and in the pharmaceutical industry."
     One aim of the program is to demonstrate the importance of
time dedicated to conducting top-notch clinical research.
     "What we are doing is training these people in scientific
research in which the patient is the unit of research," said
Charles Flexner, assistant professor of medicine and of
pharmacology and molecular sciences in the School of Medicine and
associate director of the program. "In a sense, this program is
designed to fill the gap between basic sciences and
epidemiology."
     The program employs an interdisciplinary approach, drawing
participants from the School of Medicine and the School of Public
Health. Graduates will be the first to receive a degree in a
program developed jointly by both schools. Financial support for
the program came from the dean's offices of both schools and
other sources. An advisory council, composed of faculty from each
school, meets monthly to review the program's development and to
suggest refinements in procedure and approach.
     The program draws participants from the hundreds already
engaged in advanced study at Hopkins. By adding one year of
rigorous course work to the normal fellowship program,
participants complete their work in oncology, rheumatology,
cardiology, surgery or some other specialty with a master's
degree and a sound basis in the fundamentals of clinical
investigation.
     "Human research is always going to be required to push the
frontiers of treatment," Dr. Flexner said. "The pathogenesis of
human disease is not something that can be adequately studied
through a model system. You need real live humans."
     The program focuses on subjects not generally covered in a
medical school curriculum: epidemiology, biostatistics, ethical
and regulatory issues, clinical trial design and grant writing. 
     "One year of the program is devoted exclusively to didactic
course work," said Dr. Flexner, who teaches courses in analytical
methods and topics in clinical research. "About a third of our
curriculum is devoted to biostatistics, a third to epidemiology
and a third to teaching how to select and use appropriate
research methods. The idea is to endow students with the theory
in the classroom, and then let them learn in earnest in the final
two years of their fellowship."
     The  hands-on learning promises to be the most effective
boost to the careers of the next generation of clinical
investigators. 
     "One of the most helpful things I'm finding is the time we
spend delving into previous studies looking for flaws," said
clinical pharmacology fellow and program participant Mark
Thornton. With a medical degree and a doctorate in pharmacology
already behind him, Dr. Thornton joined the program to acquire
specific skills. 
     "I found despite a good education in medicine and sciences,
neither training program prepared me for conducting clinical
investigations, especially how they are being conducted today,"
he said. "This program is teaching me everything I want to learn.
That's why I'm here, not to get my master's. I don't really need
another advanced degree."