Info

external to trial)

Additional attendees

Physicians

Trial statistician

Statisticians

Trial coordinator

Patient advocate

Trial chaira

Medical ethicist

Sponsor representativesa

Review Scope:

— Patient accrual, reporting delinquency and patient withdrawals, treatment compliance, data quality

— Adverse events

— Treatment efficacy endpoints

— Other relevant materials, including confidential reports provided by other investigators

Review Scope:

— Patient accrual, reporting delinquency and patient withdrawals, treatment compliance, data quality

— Adverse events

— Treatment efficacy endpoints

— Other relevant materials, including confidential reports provided by other investigators

Decision to stop/alter trial conduct and/or release findings may be based on:

— Evidence of benefit or harm according to monitoring guidelines or adverse events (expected or otherwise) observed in the trial

— Evidence of little likelihood that treatment difference will be realized

— External information that raises concerns regarding the scientific, clinical, or ethical assumptions on which the current trial was based

— Poor likelihood of trial yielding meaningful findings due to problems with accrual, compliance, or patient retention aNote that these individuals are typically excluded from discussions of interim efficacy data, although there is currently some debate regarding this issue.

deliberations. The policies and procedures for U.S. National Cancer Institute-sponsored Cooperative Group trials provide a good overview of DSMC structure and function for Phase III trials.61

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