University of Pittsburgh Cancer Institute (UPCI)

Protocol Review Committee

Protocol Review Criteria

Scientific merit

  • adequate background / rationale
  • clearly defined research questions
  • methodology
  • design feasibility
  • statistical power

Financial and budgetary issues

  • contracts in place for pharmaceutical company-sponsored studies
  • assurances of grant funding if indicated in the protocol
  • resources needed to perform the trial are available and covered by the study budget
  • likelihood of third party payment if no designated funding source
  • Clinical and Translational Research Centers (CTRC) submission required if no reimbursement for research procedures is needed

Clinical care and patient management issues

  • availability of resources as necessary to fulfill requirements of all timepoints of the protocol
  • availability of patients:

    • competition between proposed study vs. other studies for similar patient populations
    • prioritization plan in place for such competitive protocols
    • investigators' accrual goals achievable vs. relevant patient population at UPCI (non-competitive protocol)