Request for Proposals (RFPs): RFPs ask for short (6-8) page proposals for studies related to the Grantor drug. RFPs clearly state that NCCN Member Institutions conducting funded trials are responsible for holding the IND for studies that are not deemed IND exempt. In addition, institutions are responsible for data management, statistical analysis, safety reporting, and the quality assurance processes associated with the research. The RFPs require a detailed description of how these responsibilities will be managed for single center and multicenter trials. RFPs also require that the proposals include a scientific rationale, a proposed study design that includes a description of the study, the population to be studied, treatment plans, endpoints, a preliminary statistical evaluation plan, a feasibility plan detailing the availability of patients and/or plans for collaboration with other NCCN Member Institutions, and a proposed budget.
The NCCN ORP sends notification of RFPs to designated senior investigators at each NCCN Member Institution who are responsible for its distribution. Distribution of the RFP is also achieved through a variety of other venues including a posting on the NCCN website, e-mails to investigators in the NCCN ORP Investigator Database, and announcements to public relations, grants and contracting representatives at NCCN Member Institutions. Proposals must be submitted within an eight (8) week response cycle from the time of notification to the due date for the submission of proposals.
Proposals are required to be submitted by the institution’s Office of Sponsored Research and include a letter of support from the governing groups of the institution verifying 1) the proposal has Department Chair/Division approval, 2) institutional budgetary review and approval, 3) the priority status of the research should funding be approved, and 4) the study includes a statistical co-investigator.
Basic Science Research Project or Clinical Protocol Development:
All investigators awarded grants develop a research plan or protocol based upon the approved study proposals. The research project(s) or protocol(s) are evaluated by NCCN ORP medical staff and the Grantor to ensure conformity to the study plan delineated in the approved proposal. Grantors are informed of any proposed changes to research projects or protocols prior to their implementation that may affect the administration and/or use of the Grantor’s product (e.g., dosage, duration of treatment), the study objectives, or subject safety.
Study Initiation: The NCCN ORP negotiates contracts with each institution, including sites involved in multi-institutional studies, and ensures that all necessary regulatory requirements and appropriate regulatory documentation is fully in place before any funds and study drug are released. All studies that are approved for funding must commence within six (6) to nine (9) months after notice of approval. If an approved study is not commenced within the applicable time period, it is no longer considered an approved study and the grant is rescinded.
Adverse Events: Institutions and investigators are required to promptly report serious and other adverse events associated with the use of the study drug to the IRB, FDA, NCCN, and the Grantor according to all applicable regulations and requirements.
NCCN ORP Monitoring: Reports on the status and progress of all funded studies are performed at least once every three months. Monitoring includes an assessment of total enrollment, eligibility and evaluability. The NCCN ORP facilitates discussions with key people at non- or under-performing study sites to implement remedial steps (which may include termination of the involved study).
NCCN ORP Reporting: NCCN ORP provides Grantors detailed and written status reports on a quarterly basis. These status reports are designed according to Grantor specifications and may include the a) number of RFPs solicited and considered during the current reporting period as well as an aggregate count of same for the life of the project up to that point in time, b) number of studies/projects that were approved during the current reporting period and to whom they were awarded as well as an aggregate count of same for the life of the project up to that point in time, c) current status of each approved study or project at the time of the close of the current reporting period, d) amount of grant payments made during the current reporting period for each approved study or project as well as an aggregate amount for the life of the project up to that point in time, and e) NCCN/NCCN ORP administration costs.
Investigator Meetings: On an annual basis, funded investigators meet to present their findings. The purpose of these meetings is to share results and generate hypotheses for future studies. The agenda for each meeting is determined by the NCCN ORP in collaboration with the Grantor’s scientific staff in order to maximize the interchange of information and the utility of such meetings. NCCN plans, schedules, and facilitates these meetings.
Publication of Study Results: Principal Investigators and Project Chairs are encouraged to publish the results relating to each approved study. NCCN ORP provides the Grantor with copies of proposed manuscripts and abstracts prior to submission for publication. Grantors may request that submission of a manuscript or abstract for publication be delayed for an agreed upon additional period of time so that the Grantor can seek patent protection of existing or potential intellectual property rights.
Grant Disbursements: NCCN ORP makes study funding disbursements according to achievement of important benchmarks.
Research Projects (Basic Research):
Phase I trials:
Phase II trials and correlative studies:
Phase I/II trials: