Strategic Investments in

An Integrated Clinical Trials System

Our Goal Build a highly interactive and optimally coordinated cancer clinical trials system that will prioritize and accelerate the development of new interventions and ensure that those interventions found to be effective are efficiently and seamlessly incorporated into medical practice.

The 2004 Annual Report to the Nation on the Status of Cancer reports that observed overall cancer incidence rates dropped 0.5 percent annually while overall death rates from cancer dropped 1.1 percent each year from 1993 to 2001. Contributing to these encouraging trends are new clinical approaches to cancer prevention, early detection, diagnosis, treatment, and quality of life after treatment. The vast majority of these interventions have one feature in common: they were rigorously tested in clinical trials. Similarly, the majority of interventions arising from research proposed in this document will be tested in 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. We support trials at the NIH Clinical Center and at close to 3,000 other sites across the United States. Over 1,500 NCI-supported cancer trials are conducted annually, involving more than 12,000 investigators. With expansion over the past five years, our clinical research base has grown and become increasingly productive, providing hope for untold numbers of current and future cancer patients.

As we look to the future, we recognize the need to make our clinical trials system even more robust, to anticipate scientific and technological advancements and enhance partnerships and collaborations with an interdisciplinary and translational focus. Imaging will 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 play a critical part in the pre-clinical screening and validation of new targeted compounds. The clinical trials system of the future will facilitate the effective conduct of Phase I clinical trials, better prioritize and coordinate large Phase II and III trials, and directly address regulatory and other issues that affect the timeliness with which clinical trials can be completed and their findings translated into practice.

To make clinical trials more efficient and to accelerate the approval of new interventions through the regulatory process, NCI will enhance its working relationship with the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) to develop more streamlined policies and procedures for the conduct of clinical trials. We will build partnerships among disparate NCI clinical trial entities and with industry and promote communication among regulatory agencies and clinical trials groups. We must promote ongoing and forge new communication networks among clinical researchers and the broad community of oncologists. Finally, we need to ensure that the diagnostic and therapeutic interventions emerging from clinical trials are used to benefit all populations and contribute to reducing health disparities.

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Strengthening Scientific Prioritization and Coordination

One of our objectives is to develop a more effective infrastructure for cancer clinical trials that will strengthen scientific prioritization and coordination, thereby improving the timeliness with which clinical trials are completed and making the process more integrated, open, and inclusive of cross-disciplinary and patient advocate input. With increased resources in Fiscal Year 2006, we will:

• Strengthen flexible collaborations with industry, FDA, the Centers for Medicare and Medicaid Services (CMS), OHRP, and other public, private, academic, and patient advocacy organizations to oversee the conduct of cancer clinical trials.
• Expand state-of-the-science meetings in disease and multimodality settings not currently covered and extend the frequency of meetings of established clinical and scientific thought leaders, to identify critical research questions to be addressed by clinical trials and develop strategic plans for prioritizing and implementing those studies.
• Develop new infrastructure and procedures to standardize, coordinate, and track clinical trials development and accrual across all NCI-supported clinical trials venues.
• Expand access to centralized Institutional Review Board (IRB) resources and clinical research administrative support for all NCI-coordinated multi-institutional clinical trials.
• Increase funding for imaging in clinical trials in order to utilize the appropriate imaging tools in screening and therapy trials, evaluate new imaging probes and methodologies, enable access to the imaging data from trials in an electronic format, and facilitate evaluation of image-guided interventions.
• Increase funding for data managers, research nurses, biostatisticians, and clinicians, as well as other functions associated with NCI clinical trials, to both expand access and improve the timeliness for completion of the highest priority clinical studies.
• Increase funding for training pathways for clinical investigators, oncology research nurses, and basic, clinical, and public health teams to foster the development of a cadre of established clinical investigators who can work between bench and bedside.
• Pilot new approaches and develop prototypes for clinical trials networks that will improve the efficiency, coordination, and integration of our national efforts.

Importantly, NCI will integrate clinical trials based on a common clinical trials informatics platform that will be overseen by, and made available to, the full range of investigators working within the cancer clinical trials system. This includes NCI clinical faculty, staff, academicians, community physicians, representatives of regulatory agencies and the pharmaceutical industry, research nurses, and patient advocates. In addition, electronic repositories of currently obtained imaging data in clinical trials will serve as databases for development of future software tools and computer aided design methodologies. (For additional information, see "Early detection can eliminate a large proportion of deaths due to cancer," and "Cancer Imaging".)

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Speeding Agent Development and Biomarker Validation through Clinical Trials

With adequate resources in Fiscal Year 2006, we will also take critical steps to speed the early development of novel preventive and therapeutic agents and to validate biological markers for early detection and diagnosis and for determining the effectiveness of treatment. We will use these new resources to increase the number of promising agents evaluated in NCI-supported clinical trials and to develop new molecular diagnostic and imaging techniques capable of predicting therapeutic outcome during those studies. We will:

• Establish a program of pilot clinical trials employing novel pharmacologic, imaging, and molecular target validation principles that will facilitate new intramural-extramural partnerships and speed the early development of cancer therapeutics.
• Create broadly based working groups to identify clinically relevant surrogate molecular endpoints for clinical trials, develop core facilities to standardize and perform high throughput molecular pathologic evaluations of potential biomarkers for prediction from tumor and normal tissues collected during NCI-supported randomized clinical trials, and develop resources and clinical trial designs to validate these endpoints.
• Expand translational research capacity to use a broad range of laboratory-based correlative studies more extensively in NCI-supported clinical trials.

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Expanding the Goals of Clinical Trials

With adequate resources in Fiscal Year 2006, we will also expand the goals of our clinical trials. We will:

• Provide incentives to include innovative programs in more clinical trials structures, such as patient navigation to increase access to cancer clinical trials for minority and underserved populations.
• Support efforts to improve recruitment and retention of women and minorities in NCI-supported clinical trials programs.
• Increase minority participation in clinical trials through the NCI fellowship training program for healthcare providers and through other forums.
• Provide incentives for the enhancement of symptom management studies within the NCI-supported clinical trials system.
• Support the use of informatics systems to track and record participant information needed by healthcare providers for long-term follow-up and care after the completion of clinical trials.
• Stimulate investigations of the long-term effects of cancer treatment and related survivorship issues.
• Stimulate the use of health related quality-of-life and economic endpoints in NCI-supported Phase III trials.

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