Access to quality clinical trials advances oncology science and provides cancer patients promising new therapies and enhanced quality cancer treatment. Oncology clinical trials may measure the efficacy and safety of medical devices, treatment regimens, new pharmaceutical drugs and drug combinations. They often define new standards of care.
The American Society of Clinical Oncology defines a quality clinical trial as patient-centered medical research that involves:
- A written protocol: including trial design and scientific justification; criteria for inclusion and exclusion; outcome measures; statistical analysis plan; ethical controls; and publication policy;
- Scientific review of the protocol by independent, qualified experts; and
- Institutional Review Board (IRB) independent review and approval: The IRB reviews the investigator’s qualifications; examines the effects and safety of the study; approves the informed consent; and monitors the conduct of the study.
These standards assure that clinical trials are conducted in a manner that upholds the ethical principles of respect for persons, justice, and beneficence promulgated in the Belmont Report. Investigational new drug studies conducted under federal and international authority are highly regulated. The regulations assure adherence to these ethical standards, as well as assuring data accuracy, quality and integrity. The practice (academic or community) that has developed the infrastructure to support the conduct of clinical trials is influenced by these standards and provides high quality care to all of their patients. For this reason, the National Comprehensive Cancer Network states throughout their practice guidelines that “the NCCN believes that the best management for a cancer patient is in a clinical trial.” (http://www.nccn.org/).
According to the Georgia Center for Oncology Research and Education (Georgia CORE) there are over 400 cancer clinical trials which are open to enrollment in the state. A collaboration between the Georgia Cancer Coalition and the Georgia Society of Clinical Oncology (GASCO), Georgia CORE promotes access to clinical trials in Georgia. Georgia CORE partners with academic researchers in the design and execution of clinical trials that collect tissue and blood specimens that are analyzed in the academic laboratories. Such translational research provides the promise of accelerating scientific discovery in cancer treatment.
Georgia CORE has also developed a unique reference guide to more than 500 Georgia oncologists. The Georgia CORE Directory is designed to foster communications and collaboration among leaders in Georgia’s oncology community and provides access to important information on cancer care and research in Georgia.