Through surveys among physicians and the public, it was found that the obstacles to accrual in adult oncology were multifactorial (Table 20-1).^3–3 With these barriers in mind, the NCI undertook a series of comprehensive analyses of how it conducts and funds clinical trials by involving a wide range of stakeholders that included Cooperative Group and Cancer Center leaders, patient advocates, representatives from the FDA and the pharmaceutical industry, and government staff. The detailed reports of these reviews are available online: the 2005 review (http://integratedtrials.nci.gov/ict/ctwg_report_June2005.pdf from 2005), the 2008 review (http://ccct.cancer.gov/files/OEWG-Report.pdf), and most recently, the 2010 Institute of Medicine (IOM) Report (http://books.nap.edu/openbook.php?record_id=12879). Several important projects were launched based on the recommendations, all of which were aimed at modernizing NCI’s clinical trials regulatory and data collection systems, opening trial access to more patients and investigators, and simplifying the role of local Institutional Review Boards (IRBs) in multiinstitutional clinical trials. New opportunities were created for community physicians to participate in a broad array of clinical trials, and new tools were created to enable this participation. Two major initiatives, the Cancer Trials Support Unit (CTSU) and the Central Institutional Review Board (CIRB), were uniformly supported by all stakeholders and have now become integral parts of NCI’s clinical trials system; they are described next.

Table 20-1

Barriers to Clinical Trial Participation

Physician-Related	Patient-Related
• Inadequate funding for data management personnel	• The patient’s doctor never discussed or offered the option of participating in a trial
• Burdensome regulatory requirements	• Unaware of trials as an option • Concerns about insurance coverage
Institutional Review Board	• Fear of receiving placebo
Informed consent
Conflict of interest
• Inadequate reimbursement
• Lack of time
• Resistance by third-party payers

Cancer Trials Support Unit

The NCI CTSU is designed to facilitate one-stop online access to a broad menu of phase III trials, large phase II trials, and selected international collaborative trials by a national network of NCI investigators. Network investigators can access the CTSU menu of treatment trials from a public Web site (www.ctsu.org). The scientific leadership for each study remains within the organization that developed the trial, but patient enrollment can come from any network physician across the country, and all patient enrollment is handled through CTSU’s central registration system, the Oncology Patient Enrollment Network. By providing more physicians and their patients with the opportunity to choose from a broader menu of trials, the CTSU promotes faster accrual to individual trials, allows increased access and additional treatment options to more patients nationwide, and renders trials involving uncommon cancers more feasible. Although the clinical trials menu and centralized patient enrollment are the most visible aspects of the CTSU, another major function of the CTSU is its centralized regulatory database. For all physicians in the network, the CTSU maintains important demographic information about their sites or practices, including clinical trial group affiliation and academic/practice affiliation(s), Office for Human Research Protection assurance numbers for their sites, IRB approvals for specific protocols, and conflict of interest forms for investigators. This process enables physicians, nurses, and clinical research associates to register once annually instead of having to register for each clinical trial group or trial in which they participate. Centralizing regulatory data has reduced the workload for investigators in the field, consolidated duplicative work, and allowed clinical trial group staff to partially offload this activity to the CTSU and focus instead on protocol development and analysis.