Advancing cancer therapy depends on a host of factors: innovative ideas in drug discovery, meticulous laboratory research, experienced physicians, and a framework for safely testing potential drug candidates in patients. Mass General physician-scientists seeking to assess the potential benefits and risks of new cancer therapies through clinical trials depend on the Cancer Center Protocol Office (CCPO) to help with patient recruitment, individualized clinical care, protocol compliance, data collection, and other vital services.
The bridge between basic research and cancer therapies
Clinical trials provide the bridge between potential therapies that look promising in the laboratory and drugs that work in real people. Dr. Bruce Chabner, who was recruited from the National Institutes of Health in 1994 to serve as clinical director of the Mass General Cancer Center, launched the Mass General CCPO in 1995 to provide essential support for frontline clinical investigators and their patients.
Today, the CCPO has a highly trained staff of almost 140 people and a $10 million budget. Directed by Glenn Siegmann, MS, RPh, the staff includes clinical research nurses, clinical research coordinators and associates, and administrators. Together, these experienced professionals work with Mass General’s renowned medical oncologists, surgical oncologists, and radiation oncologists to conduct more than 500 active interventional clinical trials each year across 24 different disease centers and groups.
Clinical research nurses offer research expertise and compassionate care
When a patient or physician from anywhere in the world calls Mass General to learn about access to clinical trials, he or she is connected directly with the clinical research nurse in the relevant disease center (e.g., breast cancer, brain cancer, gastrointestinal cancer, leukemia, sarcoma, etc.). In addition to matching patients with appropriate clinical trials, these specially trained nurses work with physicians to ensure that patients and their families truly understand the risks and potential benefits of a clinical trial, provide and coordinate clinical care, and monitor the accuracy of data collection within the context of the research plan. Clinical research coordinators in each disease center help the research nurses achieve these goals, scheduling protocol-required tests, drawing blood samples, and ensuring that all samples are handled and shipped with the utmost care.
Clinical research associates serve as interface with IRB, sponsors, and government regulators
Every clinical trial at Mass General is approved and monitored by the Institutional Review Board (IRB). The IRB is an independent committee of physicians, statisticians, community representatives and others who ensure that researchers have taken every possible step to protect the rights and privacy of prospective research subjects. The CCPO’s regulatory affairs coordinators submit research plans to the IRB, write consent forms to educate patients about trials, and collect and submit required documents to both sponsors (e.g. pharmaceutical companies, foundations, or government-sponsored academic collaborations) and federal regulatory agencies.
New challenges with targeted therapies
In the new age of targeted therapies—with drug candidates targeting different genetic mutations in diseases once viewed as single entities (such as non-small cell lung cancer)—new questions about the optimal design of clinical trials arise almost daily. Issues of patient eligibility, timing of clinical trials, repeat biopsies, drug resistance, combination therapies, and even the definition of a successful outcome have become more complex. The Mass General Cancer Center has become a pioneer in targeted therapies in part because of the CCPO’s leadership experience in developing best practices for cancer clinical trials.