Resources for Research Bases
Protocol Development for Cancer Prevention and Control Trials
Overview
NCI reviews all protocols that will accrue subjects through the CCOPs. The purpose of the review is to assess:
- the scientific rationale for conducting the study,
- the study methodology,
- the feasibility of conducting the study in the CCOP network, and
- the appropriateness of the study for use in the community oncology practices that make up the CCOP network.
The process generally begins with the Research Base submitting a concept to the DCP Protocol Information Office (PIO). After review by an NCI internal committee, the concept is designated as either approve, disapprove, or revise and resubmit. A letter will be sent from the DCP Protocol Review Committee chair sent to the Research Base. For a new concept, the research base has a full year to resubmit (as either a revised concept or new protocol depending on approval status from NCI), however, since some fields of research change quickly, investigators are encouraged to resubmit in less than a year. If more than a year has elapsed, the process must start over again with a new concept submission, unless the investigator submits a letter of explanation regarding the delay.
The NCI reviews each revision from concept to full protocol, so it is important to keep this in mind when developing timelines. The process from concept to protocol development and review often takes more than a year. Once the concept is approved for protocol development, the research base expands upon the information included in the concept. Additional information that should be in a full protocol includes a consent form, details about adverse event (AE) reporting, and any questionnaires that will be use in the study.
Once the protocol is approved by NCI for activation, it must go through IRB review according to each institution's guidelines.
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Caveats
In some circumstances investigators at Research Bases want to utilize the CCOP network for accrual to a study that has received approval through peer-review and funding from a Government source other than the CCOP grant (e.g. R01). Since these studies have already undergone NCI review, they can be submitted directly as protocols, following the procedures below.
CCOP Treatment protocols are submitted to and reviewed by NCI CTEP, while cancer prevention and control / symptom management protocols are submitted to and reviewed by NCI DCP.
- Overview of Concept Process
- Submission Process
- Content of a Concept
- Concept Review Process at NCI
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- Overview of Protocol Process
- Submission Process
- Content of a Protocol
- Protocol Review Process at NCI
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Credit Assignment for Approved Protocols
Each Research Base protocol approved for CCOP and/or research base member/affiliate institution use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up.
A Research Base is required to accrue per year a minimum of 50 credits from CCOPs to cancer treatment clinical trials (unless the research base is a prevention and control only) and 50 credits from CCOPs and other research base member/affiliate institutions to cancer prevention and control clinical trials that have been approved by CTEP or DCP.
A new Research Base applicant is expected, during its initial competitive segment (project period), to develop a menu of cancer prevention and control protocols that will allow the Research Base to meet the credit minimums per year in its subsequent competing segments.
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Cancer Prevention and Control Protocols
Cancer prevention and control protocols approved for implementation by CCOP research bases are assigned cancer control credit. The CCOP program primarily supports protocols with an intervention to address cancer prevention and/or control issues. In rare instances the program will entertain the review of a pilot and/or descriptive study that will ultimately lead to an intervention addressing cancer prevention and/or control questions.
The cancer control credit assignment is determined by the NCI protocol review committee as part of the review process. The credit assignment is commensurate with the data management workload associated with a given protocol. Generally credits are assigned as follows:
| Cancer control protocol with an intervention: | 1.0 cancer control credit |
| Cancer chemo-prevention trials: | 1.0 cancer control credit + 0.3 follow-up credit |
| Pilot and/or descriptive protocol: | 0.3 - 0.5 Cancer control credit |
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The cancer control credit is a one time credit claimed by CCOP/MBCCOP grantees' against the grant year in which the patient/participant was enrolled on the protocol.
The follow-up credit can be claimed one time per year for each year that there is an intervention (i.e., chemo-preventive agent and/or placebo administered) starting the year after the patient/participant was enrolled.
Credit Reports:
- CCOP Research Base Protocol Credit Assignment Report:
a list of the treatment and cancer control credits assigned to protocols is available on the website by CCOP research base. The report is updated quarterly to coincide with the CCOP/MBCCOP quarterly accrual report to DCP.
- Approved and/or active cancer prevention and control protocols
a table is available on this website and is updated as protocols are approved. Protocols are removed from the table once closed to accrual unless the protocol receives follow-up credit.
Non-CCOP institutions receive per case reimbursements for accruals to cancer prevention and control trials from the research bases. In general per case reimbursements are as follows:
| Cancer control trial: | $2,000 per credit |
| Small-scale chemo-prevention trial: | $2,000 per credit + $300 per year for follow-up |
| Large-scale chemo-prevention trial: | $1,000 per credit + $300 per year for follow-up |
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Treatment protocols
Treatment protocols are assigned treatment credit by DCP once the protocol is approved by the Protocol Review Committee in CTEP, DCTD. In general credits are assigned as follows:
| Phase II and/or III protocol: | 1.0 Treatment credit. |
| Treatment protocol with QOL and/or cancer control endpoint(s): | 1.0 Treatment credit + 0.5 cancer control credit |
| Correlative study protocols: | No credit |
| Specimen repository protocols: | No credit |
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Quality of Life as a Part of Treatment Trials
Investigators may request cancer control credit when a quality of life secondary endpoint (or an intervention to enhance quality of life) is included in a cancer treatment trial sponsored by NCI-CTEP.
Measurement of the endpoint may be general quality of life or a specific symptom measure. In the protocol, the investigators need to make a compelling argument for including the endpoint and for selecting both the particular measure and the assessment time points. The protocol should include a discussion of the sample size needed for this particular endpoint. Often only a subset of the entire sample is needed for analyzing QOL endpoints.
NCI Program staff will review the protocol for these elements to determine if cancer control credit is warranted and how much credit should be assigned. In general, cancer control credit is not awarded for Phase I and II trials because of the small sample size and lack of comparison groups.
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This page was last updated March 1, 2006.
