NCI National Clinical Trials Network (NCTN) Program Guidelines

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Part 4: Appendices – VII. NCTN Program Data & Safety Monitoring Policy for Phase 3 & Randomized Phase 2 Trials designated Network Group Chair, who may seek the advice, in a confidential manner, of the Study Chair, Disease Committee Chair, and/or designated Network Group Statistician. 1) In the event that the DSMB/DMC recommends a study change for patient safety reasons (including early stopping for inferior therapy), the designated Network Group Chair will act to implement the change as expeditiously as possible. For studies that are being closed based on a DSMB/DMC recommendation, although CTEP pre-approval is not required, the designated Network Group Chair (or his/her designee) must inform and discuss the closure of the study with the Chief, CIB or his/her designee before disclosing the study closure to anyone. If the DSMB/DMC recommends closure of a study, the NCI/DCTD physician member of the DSMB/DMC will provide the current 24/7 contact information for the Chief, CIB or his/her designee. In the unlikely situation that the designated Network Group Chair does not concur with the DSMB/DMC recommendation, the designated Network Group Chair must discuss his/her reasons for not accepting the DSMB/DMC recommendation with the Chief, CIB. The Chief, CIB will then inform the CTEP Associate Director of the recommendation of the DSMB/DMC and of the designated Network Group Chair's reasons for disagreeing with the recommendation. The CTEP Associate Director, Chief, CIB, and the designated Network Group Chair, in consultation with the DSMB/DMC Chair, will be responsible for reaching a mutually acceptable decision about the study. Confidentiality will be maintained during these discussions, but relevant data will be shared with the designated Network Group Chair, Chief, CIB, CTEP Associate Director, and other parties whom they wish to involve in reaching a decision. In the exceptional circumstance that a mutually acceptable decision cannot be reached, final responsibility for a decision will rest with the CTEP Associate Director in consultation with the Director of the Division of Cancer Treatment and Diagnosis. 2) In the event that the DSMB/DMC recommends a study be closed early due to slow accrual, then the recommendation of the DSMB/DMC would be processed as described in 1) above. Note: NCI/DCTD/CTEP may have additional closure policies that apply to studies with slow accrual that have not yet had formal interim efficacy analyses presented to the DSMB/DMC. 3) In the event that the DSMB/DMC recommends a change in a study for reasons other than either patient safety (e.g., to extend accrual because of an event rate lower than expected) or study closure due to slow accrual, the DSMB/DMC will provide to the designated Network Group Chair an adequate rationale. In the absence of disagreement, the designated Network Group Chair will be responsible for having an amendment prepared and submitted to CTEP’s Protocol and Information Office reflecting the recommendations of the DSMB/DMC and providing the rationale for the changes. (This is required even if NCI/DCTD/CTEP approval has been obtained prior to the amendment being presented to the DSMB/DMC.) NCI/DCTD/CTEP approval of the amendment will be required prior to implementation of the change, although it is anticipated that a decision to override the recommendation of the DSMB/DMC will be made only in the most exceptional circumstances. In the event that the Network Group Chair disagrees with the DSMB/DMC recommendation, the recommendation would be processed as described in 1) above. For DSMB/DMC recommendations specific to cancer prevention and control trials funded by a CCOP Research Base grant, the appropriate NCI staff to include and report to are the DCP/COPTRG Program Director (instead of the NCI/DCTD physician member of the DSMB/DMC), the Chief of COPRTRG (instead of the Chief, CIB) and the Associate Director for Clinical Research in DCP (instead of the CTEP Associate Director), and the Director of the Division of Cancer Prevention (instead of the Director of the Division of Cancer Treatment and Diagnosis). Page 230 of 241
Part 4: Appendices – VII. NCTN Program Data & Safety Monitoring Policy for Phase 3 & Randomized Phase 2 Trials Confidentiality Procedures No communication of the deliberations or recommendations of the committee, either written or oral, should be made outside of the committee except as provided for in these policies and procedures. Statements of confidentiality should be signed by all DSMB/DMC members. Outcome (efficacy) results from phase 3, phase 2/3, and blinded randomized phase 2 trials are strictly confidential and must not be divulged to any non-member of the DSMB/DMC (excepting the designated Network Group Chair, Chief, CIB, and CTEP Associate Director as described above) without the approval of the DSMB/DMC until the recommendation to report the results are accepted and implemented. Release of Results For phase 3, phase 2/3, and blinded randomized phase 2 trials, any release of outcome data [either internal to the Network Group, to NCI personnel not members of the DSMB/DMC, or external (e.g., a paper presented at professional society meetings, seminars, papers, etc.)] prior to the final approval of general dissemination of results must be reviewed and recommended for approval by the DSMB/DMC to the designated Network Group Chair. In general, outcome data from phase 3, phase 2/3, and blinded randomized phase 2 trials would not be routinely made available to individuals outside of the DSMB/DMC until accrual has ceased and all patients have concluded their randomized treatment. After this time point, the DSMB/DMC may recommend the release of outcome data on a confidential basis to the Study Chair for planning the preparation of manuscripts, and/or to a small group of individuals for purposes of planning future trials. The DSMB/DMC will consider special requests for information from the disease committee chair prior to that time point. The DSMB/DMC should be made aware of any communication of analysis results from phase 3, phase 2/3, and blinded randomized phase 2 trials outside of the statistical center at any time. The designated Network Group Chair may not be able to accept the recommendation of the DSMB/DMC to release data for a specific trial if the Network Group and/or NCI/DCTD/CTEP has a binding agreement with a company collaborator (or other entity) that specifies data exclusivity for the trial without discussing the release with CTEP (for Network Group trials with a CTEP binding agreement) and/or the company or other collaborator (for Network Group studies that are under other binding agreements). Conflict of Interest Individuals invited to serve on the DSMB/DMC (voting and non-voting) will disclose to the designated Network Group Chair any potential, real or perceived conflicts of interest. These will include professional interest, proprietary interest and miscellaneous interest considerations as described in the NCI/DCTD/CTEP Conflict of Interest Policy for NCTN Program Phase 3 Trials (formerly known as the NCI Conflict of Interest Policy for Cooperative Group Phase 3 Trials). The designated Network Group Chair, with the advice of an ad-hoc committee, will review possible conflicts and determine whether there is sufficient basis to exclude the individual from serving on the DSMB/DMC. Potential conflicts which develop during the conduct of a trial should also be disclosed to the designated Network Group Chair. NCI/DCTD Oversight In order to satisfy its objectives of protecting patients, ensuring study integrity and assuring public confidence in the conduct of clinical trials, it is essential that the DSMB/DMC function in a manner that demonstrates competence, experience and independence of the Network Group, career or financial interests. If NCI/DCTD determines that a DSMB/DMC for a Network Group is not functioning in this manner, it will discuss with the designated Network Group Chair what changes are needed to the composition or structure of the DSMB/DMC. Page 231 of 241
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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