United States Department of Health and Human Services (HHS)

Limit: 1 // Available: 0

R. Shroff (Medicine)

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.

The NCI National Clinical Trials Network (NCTN) was established for the conduct of large-scale, national, oncology treatment and advanced imaging clinical trials in an era of precision medicine.

Recent advances in deciphering the cancer genome, along with the emergence of successful targeted agents, immunotherapies, and cellular therapies, have fundamentally changed our approach to cancer treatment and have introduced new challenges to performing clinical trials. Due to the low incidence of certain molecular abnormalities, the development of targeted therapies often requires an infrastructure for the conduct of clinical trials that can screen large numbers of patients with the same or different cancer type to identify those patients whose tumors contain the distinct molecular targets of the therapies being tested. Immunotherapeutic approaches also present a similar challenge in that not all tumor types respond to this approach, and selecting the cancer types most likely to respond is critical for success.

The NCTN's integrated and collaborative network infrastructure has allowed the Program to meet the challenges of evaluating emerging therapies within its broad investigator base drawn from NCI-designated Cancer Centers, the NCI Community Oncology Research Program (NCORP), Minority/Underserved NCORPs, and other academic and community hospitals and private practitioners across the U.S. and internationally. The primary focus of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and investigation of new advanced imaging techniques; however, appropriate preliminary studies needed for development of potential definitive trials, especially umbrella/basket trials and rare tumor trials oriented to discovery, are also conducted when an extensive, national patient catchment area is required. With its state-of-the-art clinical trials infrastructure, the NCTN can implement and completes trials rapidly. The NCTN has streamlined trial registration, data management, and tumor banking processes. It has a Cancer Trials Support Unit (CTSU) to provide online access to all necessary study materials and a Central Institutional Review Board (CIRB) to make ethics review easier and less redundant across the country. The NCTN also has appeal for industry partners such as biotechnology and pharmaceutical companies that collaborate on NCTN trials, including precision medicine trials harnessing next generation DNA and RNA sequencing methods to inform treatment choices. NCTN's resources are ideal for screening large numbers of patients to identify patients whose tumors exhibit the molecular features that may be responsive to new, targeted treatments and/or immunotherapy approaches. In addition, biospecimens collected from patients on NCTN trials are available to help determine the underlying biological reasons for response and resistance to therapy.

The NCTN also promotes the evaluation of multi-modality treatments, including surgery and radiotherapy in combination with novel agents, and has a commitment to the conduct of trials in special populations (e.g., children, adolescents, young adults, and underserved populations) as well as in rare tumor types. This focus allows the NCTN Program to complement, rather than duplicate, research conducted by the private sector. Annual accrual to NCTN trials has remained in the 17,500 to 22,000 patient range in mostly large phase 2 and phase 3 trials, but with a larger number of patients screened on study to determine whether they might benefit from the therapy under evaluation.

Each of the key components of the NCTN Program is described briefly below.

• Network Group Operations Centers: The Operations Centers provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of diseases and special populations with specific scientific strategy and goals. The Operations Centers' scientific goals may include strategic innovation in advanced technology for specific research areas (e.g., advanced imaging methods/agents, radiotherapy) and the testing of innovative concepts and tools in prospective, multi-institutional clinical trials. Operations Centers are responsible for trial operations including timely protocol development and management, compliance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) regulatory and patient protection requirements, audits, training, quality assurance, and site support. The Operations Centers are expected to be closely integrated with their corresponding Statistics and Data Management Center in all aspects of trial operations through jointly developed policies and procedures for clinical trial development and conduct. The Operations Centers are also responsible for Network Group administration, including financial management, monitoring of member institution/site performance, coordination of biospecimen collection from patients on clinical trials, and adherence to all applicable NIH/NCI policies and regulations. Network Group Operations Centers may also provide trial operations for NCI Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (NCI/DCTD, approved, multi-center phase 2 and phase 3 trials originating outside the Network Groups in special situations.
• Network Group Statistics and Data Management Centers: These Centers are responsible for providing the statistical expertise required to ensure effective scientific design and conduct of clinical trials as well as leadership in innovation in statistical methodology. These Centers are also responsible for data management, data analysis, and statistical analysis for NCTN trials led by their affiliated Network Group Operations Center as well as for translational and other ancillary studies associated with the trials.
• Network Group Integrated Translational Science Centers - These awards provide support for leadership and expertise to facilitate incorporating translational science into Network Group clinical trials.
• Network Lead Academic Participating Sites: These academic institutions/sites provide scientific leadership in development and conduct of clinical trials in association with one or more adult U.S. Network Groups as well as substantial accrual to clinical trials conducted across the entire NCTN.
• Network Radiotherapy and Imaging Core Services Center: This institution/organization provides scientific and technical expertise for incorporation of appropriate, integrated quality assurance/control and image data management for applicable clinical trials conducted by the NCTN that require specialized quality assurance/control or imaging data management and/or assessment for radiotherapy and imaging interventions. In addition, the Center may also provide similar services for other approved NCI-supported clinical trials network programs (e.g., NCI/DCTD/CTEP early phase clinical trial network program and the NCI Division of Cancer Prevention (NCI/DCP) NCI Community Oncology Research Program (NCORP).
• Canadian Collaborating Clinical Trials Network: This Canadian organization is a non-profit clinical trials organization capable of being a full partner with the U.S. Network in the conduct of large-scale, multi-site clinical trials that have relevance for U.S. cancer patient populations. Incorporation of a Canadian Clinical Trials Network as a collaborating partner brings an additional advantage as U.S. Network Groups are anticipated to have Canadian member sites. A Canadian network can help reduce duplicative regulatory staff at U.S. NCTN Group Operations Centers.

Interactions with Other NCI-supported Programs. In addition to the six key components of the NCTN that are described above that are directly funded by the NCTN Program, other NCI grant and contract-supported Programs and their awardees as well as NCI Advisory Committees have important supporting roles in carrying out the research objectives of the NCTN Program. Thus, the NCTN awardees are expected to interact as appropriate with such entities/programs as the NCI Clinical Trials Tumor Banks, the NCI Community Oncology Research Program (NCORP) and Minority/Underserved NCORPs, the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards, and NCI Advisory and Scientific Committees, including the NCI Scientific Steering Committees.

Main Research Objectives and Requirements of this NOFO

The Network Lead Academic Participating Site application must address the following 2 required functional components related to clinical treatment trials and advanced imaging trials for adult cancer patients only:

Clinical Trial Program - This functional component encompasses the LAPS scientific leadership in helping to develop and conduct clinical trials in association with one or more Network Groups, including the LAPS support of NCTN initiatives and mentorship of junior investigators.

Site Accrual Program This functional component provides robust accrual to NCTN trials across the Network, including accrual to rare cancers and accrual from special populations (e.g., minority and underserved communities, adolescents and young adults), as well as timely activation of trials and good clinical trial stewardship.

Limit: 1 //  T. Solomon (Family and Community Medicine)

PO has confirmed this is a limited submission, only the last application received from UArizona will be reviewed. 

The purpose of this program is to add to the number of Indian health professionals serving Indians by encouraging Indians to enter the health professions and removing barriers to serving Indians.

Allowable activities

• Provide outreach and recruitment of people to serve Indian communities in the health professions. Include recruitment and outreach at elementary and secondary schools as well as community colleges located on Indian reservations that your program will serve

• Incorporate a program advisory board of representatives from the Tribes and communities you will serve

• Provide summer preparatory programs for Indian students who need enrichment in the subjects of math and science needed to pursue training in the health professions

• Provide tutoring, counseling, and support to students who are enrolled in a health career program of study at your college or university

• Employ qualified Indians in the program, to the maximum extent feasible. Describe the college or university’s ability to meet this requirement

• Address the opioid crisis, which is an HHS priority, by educating and training students in opioid addiction prevention, treatment, and recovery