Reengineering Cancer Clinical Trials
Each year, NCI provides leadership, resources, and expertise for a clinical trials program that spans the entire spectrum of activity – from the discovery of novel molecules to the evaluation and application of new agents and interventions. NCI is seeking to develop a more robust infrastructure for cancer clinical trials that will strengthen scientific prioritization and coordination and improve the timeliness with which clinical trials are completed. By embracing this restructuring, NCI will ensure that life saving advances, generated by 40 years of research, make a substantive difference in reaching the NCI Challenge Goal.
To this end, NCI recently established the Clinical Trials Working Group to advise the National Cancer Advisory Board on the optimal coordination and future progress of the entire range of intramural and extramural clinical research trials. As we look to the future, we recognize the need to anticipate scientific and technological advancements and enhance partnerships that include an interdisciplinary and translational focus. The need to move the growing backlog of potential prevention and therapeutic agents through clinical testing places the integration and streamlining of clinical trials on a critical path toward improving the quality of care and quality of life for cancer patients.
Clinical oncology is entering a new age, driven by technology and advances in molecular medicine. NCI and the cancer research community must determine the best way to adapt clinical trials to meet these new opportunities. The enormous potential for more specific cancer treatment, coupled with the complexity of evaluating new, highly specific agents, requires nimble clinical trial designs. Imaging can play a role not only in monitoring treatment but also in identifying patients who are most likely to respond to a particular drug or combination therapy. In addition, imaging will be critical to the pre-clinical screening and validation of new targeted compounds. A revamped clinical trials structure will necessitate comprehensive information sharing and close collaboration among clinical, basic, and translational scientists as well as researchers who are developing modern molecular diagnostic and imaging techniques.
Proposed New Investments
NCI will build a highly interactive and optimally coordinated cancer clinical trials system that prioritizes and accelerates the development of new interventions and ensures that they are incorporated into medical practice. The report of the Clinical Trials Working Group (CTWG), Restructuring the National Cancer Clinical Trials Enterprise (PDF), included 22 recommendations, which emerged from a series of deliberations that included public comment from stakeholders, academic investigators, oncologists, and representatives from government, industry, and professional groups. New investments in Fiscal Year 2007 will be used to implement the recommendations by improving clinical trials coordination, prioritization, standardization, and operational efficiency.
- Coordination
NCI initiatives will facilitate cooperation among the functionally diverse components of the current system, including industry and Federal regulatory agencies. Activities will include expanding the NCI clinical trials database review capacity, adjusting grant data reporting requirements, and modifying NCI award guidelines to reward collaboration. NCI will institute new forms of recognition, interact with medical school deans on academic incentives, and build an awareness campaign for an expedited review process with the Food and Drug Administration (FDA). We will also establish a process for aligning NCI with the Centers for Medicare and Medicaid Services to select those studies that are appropriate for reimbursement. - Prioritization
NCI will improve scientific quality by developing an open and transparent process for the design and prioritization of clinical trials that are both science driven and patient centered. We will establish additional Scientific Steering Committees and convene State-of-the-Science meetings and focus groups that include community oncologists and patient advocates. A budget for correlative science/quality of life studies will be established. The measurement, analysis, and reporting of biomarker data in association with clinical trials will be funded. - Standardization
To minimize duplication of effort and integrate a national cancer clinical trials network, NCI will support the development of a shared infrastructure of tools and procedures for trial design, data capture, data sharing, and administrative functions. Through the cancer Biomedical Informatics Grid (caBIGTM), we will create a Web-based tool for clinical trial initiation and concur with industry/FDA on the development of standard Case Report Forms. NCI will hold a conference among investigators from industry and clinical trial sites to standardize clinical trial contract clauses. - Operational Efficiency
NCI will increase the rate of patient accrual and reduce operational barriers so that trials can be initiated and executed in a timely, cost-effective manner. We will restructure the Phase III trial funding model, begin to increase funding for sites with high accrual rates, complete analysis of institutional barriers to timely trial initiation, and develop approaches to enhance adoption of the NCI Central Institutional Review Board facilitated process.
The Clinical Trials Working Group report includes an implementation plan with a timeline and budget for each initiative and recommends that a formal evaluation system be developed to assess the success of the structuring effort over time. We anticipate the need for an annual increase of $171 million over current base NCI levels for five years to deploy a modern integrated cancer clinical trials infrastructure.
