University of Pittsburgh Cancer Institute (UPCI)

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
• General Clinical Research Center (GCRC) 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)