Clinical Research Support

Scientific Review Committee

Mission and Objectives

All cancer-related treatment or preventive intervention research protocols being submitted to the Cancer Consortium IRBs (CC-IRB or WIRB) must receive scientific review as mandated by NCI. All trials are included -- industry-sponsored, cooperative groups, NIH, unfunded -- regardless of funding source. Clinical Research Support coordinates the scientific review for the Cancer Consortium. The scientific review process has been structured to support the full range of research embodied by the Cancer Consortium.

The Scientific Review Committee (SRC) is committed to reviewing research studies for scientific merit and integration of the research effort with regards to competing protocols and Cancer Consortium research priorities.
 

Scientific Review Committee

To accommodate the breadth of expertise required for scientific review, membership is comprised of two multi-disciplinary subcommittees. Expertise represented in each subcommittee includes laboratory science, clinical trial design and conduct, biostatistics, pharmacy, nursing and oncology specialties.

Elements of SRC review:

  • Scientific merit and interest
  • Potential clinical significance
  • Study design
  • Fit of eligibility criteria with the profile of Consortium patients
  • Value added by participation of Consortium investigators
  • Fit of the trial within the context of other open trials
  • Feasibility
  • Anticipated accrual
  • Potential for enrollment of underserved or special populations

Criteria for Scientific Review

General Criteria

  • Studies with subjects who either have cancer or are at risk for cancer (including healthy normals)
  • Studies with subjects who are individually consented, enrolled or assessed
     

Types of Studies Included

Treatment intervention trials:

  • Test whether a drug or procedure is safe or effective in treating cancer or its complications
  • May also be trials designed to reduce the likelihood of disease recurrence, improve coping, quality of life, diet, or behavioral strategy (exercise, counseling)

Preventive intervention trials:

  • Test the impact of drugs, diet, exercise and education on research subjects to reduce cancer risk

Types of Studies Excluded

Non-intervention trials:

  • Imaging, diagnostic, screening, and/or survey trials to gather information from subjects but do not assess the impact on the subject nor use the information to alter the course of treatment                                                                                 

Community intervention trials:

  • Enroll groups of subjects as the experimental unit                                                                                  


 

Steps in the SRC Review Process

  • PI submits appropriate protocol documentation to CRS.
  • Protocol reviewed at SRC meeting
  • PI responds to review (result letter), provides modifications as needed
    • After SRC approval, PI submits to the Institutional Review Board (IRB) / Human Subjects Committee (HSC)

Note: If the FDA or other agency requires major changes to a protocol that has been approved by the SRC, prior to IRB/HSC review, the protocol must be re-reviewed by the full SRC.

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