"Where Are the Sites of Clinical Cancer Research Trials? "

Researchers continue to actively pursue new cancer treatments.  In 2006 in the U.S., there are over 6,000 new cancer-related therapies, procedures, devices, or drugs offered on trials at over 2,000 locations by over 5,000 principle investigators.  Greater than 400 new experimental drugs are entering the clinical trial pipeline. 

            Clinical cancer research trials are offered at local hospitals referred to as community cancer centers (CCC), and Universities termed academic medical centers (AMC), and oncology offices called community based practices (CBP).   Currently 80% of all cancer care visits occur in the 1200 CBPs nationwide, with an increasing amount of clinical cancer trials being performed within CBPs.    Clearly, the way to maximize patient access and enrollment is to include CBPs in the clinical trial network.  The tightening medical reimbursement continues to strain AMC and CCC research staff in already overburdened centers, especially if an inefficient clinical research program is not profitable by lack of accrual.   An unfortunate, but common scenario is when local clinics and cancer centers compete for patients and revenue, which results in fewer patients enrolling for trials.  A ‘win-win’ solution to this competition is for cancer centers to send clinical research coordinators (CRCs) out to the surrounding private practices as a community research network.  This also benefits patients who may keep their private oncologist for continuity.  Additionally, private oncologists may directly participate in trials and continue to generate revenue within their own practices.  AMCs have also adapted to this network model by creating research oncology consortiums (example: Duke Oncology Consortium) that offer larger statewide networks of clinical research trials.

            An example of a national network for local research is US Oncology (www.usoncology.com), which is the nation’s largest incorporated network of oncology offices.  It is affiliated with 850 oncologists in 450 cancer sites and currently offers 70 clinical cancer research trials.  Another recent adaptation to the network trial model is International Oncology Network’s (ION) (www.iononline.com) early expansion into clinical research trials.  ION is the nation’s largest chemotherapy group purchasing organization (GPO), serving 2500 oncologists in CBPs, and may soon provide clinical research trial options.

            Another model coordinating clinical research trials is the Site Management Organization (SMO).  These organizations enable community physician/investigators to participate in industry sponsored trials within independent private practices.  The pharmaceutical industry’s previous dependence on inefficient large AMCs now have another channel for dissemination of clinical trials.  SMOs offer the pharmaceutical industry an efficient direct interface to investigators resulting in increased patient access through private practices and reduced costs.  Noting that each day’s delay in gaining FDA approval costs pharmaceutical industry approximately  $1.3 million.  Since 70% of the money for clinical research trials comes from the pharmaceutical industry rather than the NCI, there is an incentive to deploy trails more efficiently with rapid accrual through large networks in private oncologists offices.

            The newest model to enter the arena of clinical trial coordination is the Trial Management Organization (TMO).   TMOs combine the role of both SMOs and Contract Research Organizations (CROs) into one large network of clinical sites capable of writing investigator initiated research protocols, project management of the drug pipeline, and coordinating trials from phase I to phase IV.  The TMO model is the most efficient deployment of cancer trials and is becoming vertically integrated with electronic medical records for real-time data collection and safety monitoring.  This model will rapidly accelerate cancer drug development.