Clinical trials of new drugs and medical devices offer hope and sometimes positive outcomes for thousands of patients every year. But the trials often carry risks as well.
Making sure that those patients are protected is the job of institutional review boards (IRBs) like the one at Northwestern University, where Maureen Brady Moran chairs one of the IRB's review panels. Her panel oversees protection of participants in clinical trials of new cancer therapies as well as other research studies at the medical school. "We and other institutions are required by the Food and Drug Administration—the FDA—to ensure that possible risks are outweighed by the potential benefits of the proposed research," she explains. IRBs also ensure that potential participants are adequately informed of risks, and kept apprised of additional relevant information that may become available during the course of the research.
In her day-to-day work at Northwestern, Maureen is an assistant professor at the Feinberg School of Medicine, where she teaches Ethical Issues in Clinical Research, and the human subjects research component of other courses taken both by medical students and students in the life sciences. She is also director of admissions and graduate affairs for the medical school's program in public health. She has an undergraduate degree in food and nutrition from the University of St. Joseph in West Hartford, Connecticut, and a master's degree in public health / chronic disease epidemiology from Yale School of Public Health. Prior to her current positions, Maureen worked in the fields of dietetics, geriatrics, and preventive medicine.
Of the eight or nine hundred research studies Maureen's panel is responsible for annually, about a quarter are related to cancer therapies. Currently, nationwide, over 16,000 clinical trials are underway. Often, especially in oncology, the same trial will be conducted at multiple sites both to acquire enough subjects and to make results more generalizable. Clinical trials almost always combine an existing standard of care with a new therapy.
Maureen explains that clinical trial participants interact with the investigating team, which is responsible for communicating all the necessary information and making sure that informed consent is obtained. The IRB is there to monitor the processes through regular reviews, and respond to problems. Where problems occur, the IRB can require additional training for the investigators, observe the consent process, or have the project audited.
"Patients' involvement in clinical trials often last weeks or months – sometimes even years," Maureen says, "Participants want to know, what are the risks, what are you going to do to me, and what might happen? We help investigators interpret the research protocols in lay language to make sure everything is clear. Our absolute commitment is to making sure that investigators are acting at all times in the best interests of clinical trial participants."