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Reclaiming Our Province:
The Role of Academic Medical Centers in Clinical Trials

By James Breitmeyer, M.D., Ph.D.

James Breitmeyer, M.D., Ph.D., President and CEO, Harvard Clinical Research Institute

Over the past decade, commercially sponsored research organizations have out-distanced academic medical centers in conducting clinical trials. Overall, academic centers have been slow to respond to this shift, which has coincided with a virtual explosion in the volume and complexity of biomedical research. Now it is time for our academic research centers to take back their unique leadership role.

Last May, when President Clinton and Health and Human Services Secretary Donna E. Shalala announced that new regulations would be imposed to improve protection of human subjects, a door was opened for academic research organizations to retake center stage. To achieve these strengthened research standards, the president proposed rigorous new training at every stage of clinical trials.

We in the academic research community now can ask, who is best equipped to take on a medical training mission of such magnitude? Certainly not the commercial clinical research organizations (CROs) that tend to include among their trial sites independent storefront physician offices, small community hospitals, and solo practice settings as venues to conduct clinical research.

Clinical trials have become increasingly complex due to two major factors: the remarkable application of genetic information and engineering via bio-technology, and the growing national concern over patient privacy and consent. If we successfully address these twin challenges, academic medical centers can reassert themselves as major resources in the development of therapeutic solutions against diseases that have devastating effects on American families.

Without question, academic research centers have always been the driving force in bringing discovery to the bedside. But we must now take the bold step of creating a culture that defines us as unquestionably the most viable location for clinical trials. In creating this new ethos, we will be strengthening an already formidable system, for there is an intellectual added value for studies done in an academic environment. That is a message that must be heard by all clinical trial sponsors.

In reasserting leadership, we must not be afraid to embrace new, rational regulations that improve the medical ethics and patient safety of clinical trials. There must be solid safeguards to ensure that human subjects can and should place their full trust in academic investigators. Further, to reverse the tide and bring the preponderance of human trials back to the academic research centers, we have to respond to the demands of clinical trial sponsors for efficiency and speed.

We must all raise the bar. The Harvard Clinical Research Institute will be studying the way clinical trials are conducted and will offer proposals about what we should do differently. As we develop novel approaches, we will work to ensure that our program includes effective training methods to heighten medical ethics. To achieve this, all of our researchers will have to maintain a very high standard of scientific and ethical integrity.

Last June, Joseph Martin, M.D., Ph.D., dean of Harvard Medical School, considered relaxing Harvard's conflict-of-interest guidelines. After careful examination and debate, Dr. Martin concluded that the Harvard regulations, albeit stringent, are appropriate for today's environment. High standards are paramount. We need to be careful to avoid any action or perception that clinical trial physicians are experimenting on patients, rather than first and foremost caring for patients.

The academic setting should be a place that offers patients innovative and important new experimental therapies. As physicians, we assume the sacred responsibility to take care of our patients in the best way possible. I believe that includes bringing them new treatments as soon as they become available and offering them the essential opportunity to participate in a clinical trial.

I predict that as physicians receive more training in the protection of human subjects and in medical ethics, the lines of communication between investigator and patient will open up. The distinction between potential risks and benefits will hopefully be clearer. In many medical environments, faculty with major involvements in clinical research have sometimes had difficulty achieving academic recognition or promotion for their efforts.

In changing the clinical trial culture, there also should be greater incentives for physicians to choose a career as a trialist. We need to encourage young doctors to become involved in clinical trials and reward them through promotions for that participation. Therefore, I challenge deans, faculty, and hospital chairs to create an environment that rewards doctors who participate and specialize in these trials.

Clinical trials have thrived in America's academic medical centers, and they have benefited millions of people while adding to the treasury of human science. We must be the ones who ensure through our own dedicated efforts that this grand medical tradition will continue.

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