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."
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