NCCN Research & Business Resources
Research Grant Process
Pre-approval Process
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.
Post Approval Process
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):
- 50% upon approval of funding
- 35% upon completion of research and receipt of final report by NCCN
- 15% upon submission of article for publication
Phase I trials:
- 25% after IRB approval and implementation
- Based on the per subject costs (after the initial 25% of funding has been accounted
for) and based on subject accrual, funds are provided on a quarterly basis for eligible
subjects enrolled on a study, based on the per subject rate up to a maximum of 85%
of the funding
- 15% of funds provided after submission of a manuscript for publication
Phase II trials and correlative studies:
- 25% after IRB approval and implementation
- 30% after 50% subject accrual
- 30% after 100% subject accrual
- 15% of funds provided after submission of a manuscript for publication
Phase I/II trials:
- 25% of total award after IRB approval and implementation of the Phase I Study
- 30% of total award after 50% accrual of study subjects are enrolled in the Phase
II study
- 30% of total award after 100% accrual of study subjects to the Phase II study
- 15% of total award after submission of manuscript for publication