"Who Sponsors Clinical Cancer Research Trials "

There have been important advances in streamlining trials and broadening the group of potential sponsors.  Cancer trials are sponsored by the National Cancer Institute (NCI) or Pharmaceutical Industry.   Cooperative Groups are a NCI-funded group of oncologists, usually spearheaded by an AMC, that design and offer most of the trials at Community Cancer Centers (CCC) and Community Based Practices (CBP).  The Cancer Therapy Evaluation Program (CTEP, http://ctep.info.nih.gov) of the NCI funds and prevents duplication of Cooperative Group trials.  CTEP reviews over 500 trials per year and provides resources for investigators to design trials through the Cancer Trials Support Unit (CTST www.ctsu.org). 

            There are many cooperative groups with different specialty strengths in trials of tumor types.  Examples include the Eastern Cooperative Oncology Group (ECOG), South Western Oncology Group (SWOG), Cancer and Leukemia Group B (CALGB), National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), Breast Cancer International Research Group (BCIRG), European Organization for Research and Treatment of Cancer (EORTC).  These cooperative groups are major “think tanks” that design, sponsor, and conduct large clinical trials that will impact changes in standard of care.  Cooperative group trials are dispersed by Community Clinical Oncology Programs (CCOP) such as the Southeast Cancer Control Consortium (SCCC), which works like a “regional clearing house” to directly link Community Cancer Centers (CCC) with newly opened trials.  Through the CCOPs, each of the 650 CCCs do not have to lobby all the cooperative groups for each new trial.  The downside to CCOPs is they provide another administrative layer in deploying trials. 

            An exciting but uncommon sponsor of a trial is the AMC itself (usually funded by the NCI).  In some (albeit rare) cases, the AMC discovers a cancer drug and develops it through preclinical studies and human Phase I clinical research trials entirely within the AMC campus.  But, sponsoring a new drug in Phase II or III clinical research trials is too expensive for the largest university AMCs to finance independently.   If an academic researcher discovers a potential cancer drug in the lab, its university patent rights are often licensed or sold to a pharmaceutical company, and then tested in humans by pharmaceutical industry sponsorship.  Most universities have an Office of Technology Development (OTD) that assist in the spin off of new discoveries to the biotechnology and pharmaceutical industries.  The OTD negotiates on behalf of the university royalties for patent licensure and may even accept equity in a start-up biotechnology company that transfers a university discovery, technology, or drug patent. 

            In 1991, 80% of US clinical cancer trials were performed in AMCs.  By 1998, this number had decreased to 40%, due to increasing cooperative group sponsored trials at Community Cancer Centers (CCCs).  The Association of Community Cancer Centers (ACCC) is the largest organization of CCCs (http://www.accc-cancer.org/main2001.shtml) and has helped develop the clinical research capabilities of CCCs.   Overall, patients have benefited due to increased access to a greater number of trials offered locally at CCCs.  Additionally, faster accrual at CCCs has outpaced AMCs and enabled many trials to meet enrollment goals.  Today, the majority of U.S. patients on trials are enrolled at CCCs.  However, despite this improvement in access, participation in US clinical cancer trials remains dismally low compared to our European counterparts.