Research and Clinical Trials
Most advances in the diagnosis, treatment and care of patients with cancer have occurred because of research studies called "clinical trials" or "protocols." Clinical trials are designed to help health care professionals test new approaches to the diagnosis, treatment or prevention of cancer.
Improved diagnostic tests and new treatments have led to cures for patients with some cancers. Clinical trials that study the effect of cancer treatments such as surgery, radiation therapy, chemotherapy and biological therapy have helped health care professionals find better ways to treat cancer.
Cancer patients and people who are at high risk for developing cancer are often asked to participate in a clinical trial. Clinical trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, or new combination's of treatment or new methods, such as gene therapy.
Patients are never denied a known, effective treatment. And researchers believe that the new treatment or drug may improve their health.
Patients and their families should gather as much information as needed in order to be able to make an informed decision about participating in a clinical trial.
As members of national cooperative groups such as National Surgical Adjuvant Breast and Bowel Project(NSABP), Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG) and the Cancer Trials Support Unit (CTSU), large cooperative groups that write the trials clinical trials, RCC offers patients access to the same clinical trials available at large, well known academic cancer centers. In addition, through an affiliation with UPMC CancerCenter / University of Pittsburgh Cancer Institute (UPCI), The RCC is part of the UPMC network of clinical trial sites. Various clinical trials involving use of Radiation Therapy require validation of the entire treatment process including treatment planning and delivery by a National Organization such as Radiological Physics Center(RPC) at the MD Anderson Cancer Center in Houston, Texas. The process involves simulating patient treatment planning and delivery for each specific clinical site using a specially designed phantom provided by RPC. The actual dose delivered to various parts of the phantom is measured by RPC and compared to the planned dose. This phantom study provides an accurate analysis of the quality of treatment patients will receive at The Regional Cancer Center and it is required for participation in all protocols.
RCC Gets National Attention for Research Activities
A significant amount of time and energy is devoted to identifying matches between clinical trial opportunities and interested, eligible patients. Hundreds of patients can be evaluated by trained clinical personnel before a match is found. Once matched, the enrollment process for trials is often very involved, with data collection and trial registration extending over several weeks. Then regular monitoring of patients and ongoing data collection continue the process. Some trials require that patients be followed for their lifetime, extending the involvement of clinical research staff far beyond trial enrollment.
Active participation in clinical research requires a major commitment of specially trained staff and other support resources. Clinical cooperative research groups rally to keep energy up among group participants who are doing this tedious work in the clinical settings. RCC’s commitment to an active research program shows with success matching patients for one particular trial. RCC’s rank of 7th in the nation, among 197 participating sites was recently published in the RTOG newsletter.
RCC Institutional Review Board (IRB)
Any organization participating in clinical trials is required to have an IRB designed to protect patients who take part in clinical studies. IRBs review and must approve the protocols for all clinical trials funded by the Federal Government. IRBs check to see that the study is well-designed, does not involve undue risks, and includes safeguards for patients. Clinical trials open at RCC are reviewed by IRBs from UPMC Hamot, Saint Vincent Hospital and UPMC CancerCenter that are comprised of scientists, doctors, clinicians, clergy and consumers.
Patient rights and safety are priorities of all clinical research activities. All ethical principles and guidelines for the protection of human subjects of research are strictly followed.