Green -- for items getting 'Full Review'

Yellow -- for item getting 'Safety Review'

Blue -- for item getting 'Developmental Strategy Review'

Red -- for item **[not reviewed]{.underline}** by CTEP

CTEP's Protocol Review Committee (which includes staff of other DCTD
programs, plus ad hoc reviewers) must review the following categories of
protocols\*

-   studies involving CTEP supplied investigational agents

-   all CTEP funded Cooperative Group and Consortium (NABTT, NABTC,
    PBTC, AMC, etc.) trials

-   CCOP research base treatment

-   ACRIN protocols that involve treatment interventions

The type of review is dependent on whether the study:

-   utilizes a CTEP IND agent;

-   is from a CTEP funded trial organization and which type (e.g.,
    Cooperative Groups vs. UO1 funded Consortia);

-   has already received NIH-type peer review for the specific protocol
    (e.g. R21)

-   focus is on treatment vs. correlative science;

-   involves collaboration in an ongoing international trial;

-   is expected to accrue [\>]{.underline} 100 patients;

-   is a phase 1, 2 or 3 trial.

> A summary of the review types follows:

-   **[Full Review]{.underline}** --

    -   [Types of studies:]{.underline} All studies that utilize a CTEP
        IND agent and are not specifically peer reviewed; OR CTEP funded
        treatment trials with an expected accrual [\>]{.underline} 100
        patients; OR all consortia trials funded by a cooperative
        agreement or contract.

    -   [Focus of NCI review]{.underline}: The protocol is reviewed for
        completeness and clarity; scientific merit risk: benefit ratio;
        optimal design; accrual rate; patient safety; pharmaceutical
        accuracy; adequacy of regulatory and human subject's protection
        aspects; and agent availability and duplication with existing
        studies.

    -   [NCI Reviewer comments]{.underline}: Reviewers may provide
        'comments requiring a response' and/or 'recommendations' to
        modify any aspect of the trial.

    -   [Typical assignment of NCI reviewers]{.underline}: IDB; BRB;
        PMB; CTMB; CIB (if disease specific, phase 2 or 3; or Group
        involvement); and other specialists as appropriate (e.g.
        imaging; bio-markers; quality-of-life; etc..).

-   **[Safety Review]{.underline}** --

    -   [Types of trials:]{.underline} Group phase 1 treatment trial
        [without]{.underline} a CTEP IND agent AND an expected accrual
        \< 100 patients; OR the study has received funding after
        specific NIH-type peer review.

    -   [Focus of NCI review]{.underline}: The protocol is reviewed for
        patient safety; pharmaceutical accuracy; and adequacy of
        regulatory and human subject's protection aspects.

    -   [NCI Reviewer comments]{.underline}: Reviewers may provide
        'recommendations' and/or 'comments requiring a response' to
        modify the study within the focus area of the review.
        Recommendation maybe made in other areas for CTEP IND agent
        studies.

    -   [Typical assignment of NCI reviewers]{.underline}: CIB; CTMB; &
        PMB (if a treatment trial). Other reviewers with specialized
        expertise may be assigned as appropriate.

-   **[International Collaboration]{.underline}** --

    -   [Types of Trials:]{.underline}: When CTEP-funded organizations,
        typically Cooperative Groups, wish to join a new trial or a
        study already under way under the sponsorship of another major
        international clinical trials organization (e.g. EORTC).

    -   [Focus of NCI review:]{.underline} It is assumed that as a
        result of the prior international review, that there would be
        limited ability to reconsider major design issues. In this case
        the protocol is reviewed first with regard to whether the
        scientific question merits commitment of funded CTEP resources,
        and if so it is reviewed for patient safety; pharmaceutical
        accuracy; and adequacy of regulatory and human subject's
        protection aspects.

    -   [NCI Reviewer comments:]{.underline} Will focus on whether to
        commit Group resources towards the trial. Other comments will be
        limited to recommendations within the focus area of the review.

    -   [Typical assignment of NCI reviewers:]{.underline} CIB; PMB; BRB
        & CTMB. Other reviewers with specialized expertise may be
        assigned as appropriate.

-   **[Developmental Strategy Review]{.underline}** --

    -   [Types of Trials]{.underline}: These are Cooperative Group phase
        2 treatment trials [without]{.underline} a CTEP IND agent AND an
        expected accrual \< 100 patients that are undertaken as
        preliminary to an eventual large randomized phase 3 trial (with
        its attendant commitment of substantial resources and funds); or
        a definitive correlative science (non-treatment) trial with
        expected accrual of [\>]{.underline} 100 patients..

    -   [Focus of NCI review]{.underline}: Review at this stage provides
        the Group with an early indication of the potential scientific
        value of an eventual phase 3 question. Particularly in the
        context of other potential trials.

    -   [NCI reviewer Comments]{.underline}: This category of protocol
        receives a limited review. In general NCI comments will be
        limited to "recommendations only" regarding the scientific merit
        of the protocol. These studies are [not]{.underline} reviewed by
        NCI for human subject protection or for pharmaceutical and
        regulatory accuracy/compliance. The submitting organization
        assumes full responsibility for assuring compliance with all
        federal or NCI-specific regulations regarding these regulatory
        and safety issues for this category of trials. In the event that
        a NCI scientific reviewer finds a regulatory or safety issue
        that is incorrect or non-compliant in the course of this limited
        review, this will be indicated to the Group as "comments
        requiring a response".

    -   [Typical assignment of NCI reviewers]{.underline}: CIB and BRB
        (and CDP for non-treatment trials)

-   **[File Only]{.underline}** --

    -   [Types of Trials]{.underline}: All non-treatment trials with
        expected accrual \< 100

    -   [Focus of NCI review]{.underline}: No review required.

    -   [NCI reviewer comments]{.underline}: None provided. The
        submitting organization assumes full responsibility for assuring
        compliance with all federal or NCI-specific regulations
        regarding these regulatory and safety issues for any file-only
        study.

    -   [Typical assignment of NCI reviewers]{.underline}: None
        required.

**Please note:** Trials without NIH funding, trials with commercial
agent or industry sponsored IND's, without CTEP IND agents, (e.g. SPORE
or cancer center trials using industry or locally supplied agents) do
not get [any]{.underline} CTEP review. The investigator & institution
are entirely responsible for compliance with federal and local
regulations.