[CCOP Cancer Prevention and Control Concept Development and Approval
Process]{.underline}

1.  Overview

Concept submission is the first step in the process of receiving
approval from the Division of Cancer Prevention (DCP) for opening a
cancer prevention or control study in the CCOP network. After receiving
approval for a concept, the Research Base develops a full protocol and
submits the protocol to DCP for review by the Cancer Prevention and
Control Protocol Review Committee. The DCP assigns CCOP credit when it
approves the protocol.

In some circumstances investigators at Research Bases want to utilize
the CCOP network for accrual to a study that has received approval
through a peer review process and funding from a Government source other
than the CCOP grant (e.g. NIH R01 grant). These studies need not be
submitted as concepts but should be submitted directly as protocols (see
Protocol Process).

The Research Base should have a detailed, specific study in mind before
submitting a concept, and the concept should have been approved by all
necessary components at the Research Base before submission to DCP.
Although not a full protocol, the concept should provide sufficient
information to establish the scientific rationale for the proposed
study, describe the study methodology, and support the feasibility of
conducting a successful study. Concepts do not need to include consent
forms or case report forms, although reviewers appreciate receiving
copies of questionnaires to be used. There are no page limits, but most
concepts can provide the necessary information in 5-10 pages. The DCP
does not have a set format for concepts, but it needs to include the
information listed below.

2.  Submission Process

Although DCP encourages investigators to communicate with program
officials (e.g. program directors, statisticians) when developing
concepts, the final concept document must be submitted to the Protocol
Information Office (PIO) of DCP.

> 2.1. How to submit a concept
>
> 2.1.1. Research Bases submit concepts electronically to
> <NCI_DCP_PIO@mail.nih.gov>
>
> 2.1.2. Attachments that are difficult to send electronically may be
> sent by mail:

US Mail Address:

Protocol Information Office

Division of Cancer Prevention

National Cancer Institute

Executive Plaza North, Room 2053

6130 Executive Blvd MSC 7323,

Bethesda MD 20892‑7323

Commercial Delivery Address:

Protocol Information Office

Division of Cancer Prevention

National Cancer Institute

Executive Plaza North, Room 2053

6130 Executive Blvd.

Rockville, MD 20852

3.  Content of a Concept

> 3.1. Cancer Control Checklist and Protocol Submission Worksheet

All new concepts must be accompanied by the Cancer Control Checklist and
Protocol Submission Worksheet v4.0. All relevant sections of the PSW
must be completed. These forms can be downloaded from
<http://www.cancer.gov/prevention/pio/instructions.html> All subsequent
submissions for the same concept only require the Cancer Control
Checklist.

> 3.2. Title Page

The title page of the concept is the primary source of identifying
information for the Protocol Information Office (PIO) of DCP. Each
submitted concept must have a title page that contains the following
items:

-   Date of document

-   Local concept number (i.e., institution or group number)

-   Title of study

-   A single study chair who will be responsible for the study,
    including his or her name, institution, address, phone and fax
    numbers, and e-mail address

-   Full name of Research Base submitting the study

-   If agents are being requested from DCP, a listing of each agent by
    name and NSC number.

> 3.3. Background

The Background is the most important section of the concept. It provides
the reviewers the relevant arguments for conducting the proposed study.

> 3.3.1. Detailed rationale for study
>
> -What is the current state of knowledge or clinical practice?
>
> -What will this study contribute to cancer prevention or control?
>
> -Why is the study design the best way to make this contribution?
> (include information about the proposed study population and
> intervention)
>
> -How will this research affect subsequent research?
>
> -Why were the endpoints chosen? Justify choice of effect size.
>
> -Do data exist from a pilot study supporting conduct the proposed
> study?
>
> 3.3.2. Literature Review
>
> -A focused review of relevant literature with citations, covering
> current knowledge, other studies that have contributed information
> applicable to the proposed study, information on intervention and
> procedures to be used, and information on epidemiology and related
> fields justifying the proposed research and its methodology.
>
> 3.3.3. Feasibility
>
> -Provide data to support the anticipated accrual rate; specify
> procedures for recruitment and retention.
>
> -Level of participation and anticipated accrual from the CCOPs. State
> if CCOP members have been involved in developing or reviewing the
> concept. What is level of interest expressed by CCOPs?
>
> -If the study will involve costs in addition to data management,
> describe them and include a source of funding.
>
> 3.4 Study Objective(s)
>
> -One or more objectives should describe the specific information the
> investigators hope to obtain from the study. Other parts of the
> concept (especially background, study design, and statistics) should
> relate clearly to each objective.

3.5. Intervention Plan and Study Design

> 3.5.1. Schema
>
> -This one page diagram provides an overview of the study design. A
> clear and detailed schema facilitates concept review, and the schema=s
> eventual incorporation into the protocol will facilitate conduct of
> the study. To be most useful, it should include sample size;
> eligibility criteria; major stratification factors; timing of
> randomization, intervention, and data collection; and measurement(s)
> of outcome. If a Research Base prefers not to provide this level of
> detail in the schema to be used by accrual sites, it can submit a
> detailed schema as an attachment to a cover letter accompanying the
> concept for use during concept review.
>
> 3.5.2. Methodology
>
> 3.5.2.1. Characteristics of study population
>
> -Eligibility and ineligibility criteria (The concept only needs to
> include criteria that are necessary to understand the study and those
> that affect feasibility)
>
> 3.5.2.2. Definitions for primary and secondary endpoints
>
> 3.5.2.3. Stratification factors and justification for including them
>
> 3.5.2.4. Plans for intervention
>
> -Dose and schedule for intervention together with justification
>
> 3.5.2.5. Plans for data collection
>
> -Submit copies of data collection instruments that are not widely used
> in symptom management trials
>
> -Timing and content of data collection, particularly with regard to
> collection of data required for measuring the primary endpoint.
>
> 3.6. Drug Distribution
>
> -Provider of drug. Specify if drug is currently available to the
> research base for the trial.
>
> -If complementary and alternative medicine agent, specify probable
> manufacturer of the product to be used, if known.
>
> 3.7 Behavioral Intervention
>
> -Describe the intervention. Include a discussion of the availability
> of resources in the CCOP setting (e.g. staff, facilities, equipment)
> to implement the intervention.
>
> -Justification for the proposed control group (if applicable).
>
> 3.8. Statistics
>
> -The concept should include a hypothesis, a sample size calculation,
> and plans for analyzing the primary endpoint with enough detail to
> calculate the sample size. Although often described in sections other
> than the Statistics Section, the sample size determination requires a
> clear definition of the primary endpoint and the timing of data
> collection.

4.  Concept Review Process

> 4.1. Receipt in DCP PIO
>
> -DCP conducts reviews within 4-6 weeks after receipt of concept. This
> allows time to schedule reviewers and also gives reviewers adequate
> time to review the concept.
>
> -If the concept does not contain the required information, PIO will
> return concept with an explanation.
>
> 4.2. Review Group
>
> -The standing Cancer Prevention and Control Concept Review Committee
> will be augmented as needed to provide scientific expertise by invited
> reviewers inside and/or outside the NCI.
>
> -The chair of the Cancer Prevention and Control Concept Review
> Committee conducts the reviews and is the principal contact with
> investigators regarding concepts under review. In addition, Research
> Bases are always encouraged to contact their Program Director.
>
> 4.3. Purpose of the Review
>
> -The concept review will assess the merits of the concept as a cancer
> control study and the feasibility of implementing a successful study
> in the community oncology practices that make up the CCOP network.
>
> 4.4. Outcome of the Review
>
> -DCP will send all correspondence by mail and/or email regarding
> concept reviews to 1) Principal Investigator of the Research Base, 2)
> Study Chair, and 3) one other person designated by each Research Base
> to receive copies of correspondence related to all concepts and
> protocols under review at DCP. DCP sends results of concept reviews
> within four weeks of the review meeting.
>
> Concept review letters can take one of three forms:
>
> 4.4.1. Concept Approved
>
> -The Committee has determined that the proposed research is feasible
> and that the methodology will provide information potentially useful
> for prevention of cancer, prevention or treatment of side effects, or
> for improving a patient=s quality of life.
>
> -Investigator should use the approved concept together with comments
> from the Concept Review Committee to develop a full protocol, which
> will go through the protocol review process.
>
> -Because the utility of research and scientific basis for conducting a
> study will change over time, concept approval expires 12 months after
> receipt of the approval letter. If the Research Base intends to submit
> a protocol that will be received later than 12 months after concept
> approval, they should contact their program director for guidance.
>
> 4.4.2. Revise and Resubmit
>
> -The Committee has determined that identifiable and potentially
> remediable problems preclude the development of a protocol based on
> the submitted concept.
>
> -Investigator should respond to all the Committee=s comments, change
> the concept where necessary, and resubmit to the DCP Protocol
> Information Office as a revised concept for further review.
>
> 4.4.3. Concept Rejected
>
> -The Committee has determined that the concept does not justify
> conduct of the proposed study, that the study is not feasible or is
> already being conducted, or is otherwise not relevant to cancer
> prevention or control as defined by the CCOP Program. The Committee
> will detail its findings in a letter. The investigator can use this
> information to design a new concept, but this concept will be
> submitted and reviewed as a new submission.