Protocol Review Process:
All cancer-related protocols campus-wide will undergo review.
Clinical Protocols and Data Management (weekly) meeting (CPDM)
LOI review – An LOI must be submitted for all studies (therapeutic, correlative, observational, outcome, prevention, supportive, screening, detection, diagnostic, epidemiologic, ancillary, psychosocial, etc.). The LOI will be reviewed to determine if the budget is adequate to support the study and staff required, feasibility for conduct at UAB, brief review of the science and current trials to see if there are competing trials. Based on the review of the LOI, a determination will be made whether or not the protocol will require full review by CTRC (80%) or administrative review only for laboratory/pathology studies. Retrospective chart review studies will not require full review by the CTRC.
The LOI process also allows the capturing of all studies into the database and categorized according to the NCI criteria for reporting.
Disease Working Group (DWG) reviews
The LOI is submitted to the appropriate DWG at the same time it is submitted to the CPDM group for review. The DWGs review the LOI for interest in conducting the trial at UAB, competing trials, prioritization of trials, safety issues, etc.
Once the LOI is approved by both the CPDM and the DWG, it is forwarded to the Clinical Trials Review Committee (CTRC) for internal scientific review.
Clinical Trials Review Committee (CTRC)
The Clinical Trials Review Committee is made up of 38 members with representation from Hematology Oncology, Radiation Oncology, Pathology, Bone Marrow Transplantation, Gynecology Oncology, GU Oncology, Neuro-Oncology, Cancer Control and Population Sciences, Pediatric Oncology, Surgery nurses, basic scientists, statisticians and the recent addition of 2 radiologists.
The CTRC meets twice per month (every 1st and 3rd Friday). All protocols, consent forms and Investigator Brochures (if applicable) are forwarded electronically. Review assignments are forwarded to 2 independent clinical reviewers, 2 independent statisticians, a radiologist and a nurse. If the protocol involves gene therapy, 3 gene therapy reviewers are also assigned. The agenda and all meeting material pertinent to the meeting are posted on a “CTRC” secured website for all remaining members to access for the upcoming meeting.
The LOI is available to each reviewer for the protocol to refer to for information that may affect their review, i.e., anticipated accrual, funding, etc. At the meeting the 2 clinical reviewers, statisticians, nurse, and radiologist present their reviews. There is general discussion from the committee mediated by the chairman.
A recommendation for approval, administrative review (minor concerns), resubmission (major concerns requiring revisions) or disapproval is made along with the assignment of a priority score. The priority score aids in prioritizing trials for the Clinical Studies Unit Shared Facility.
The P.I. receives a written review within 2-5 working days.
If the protocol requires administrative review, it can be turned back to the P.I. within 3 days upon receipt of their response.
If the protocol requires resubmission, the protocol will be scheduled for re-review at the next Clinical Trials Review Committee meeting (meets every 2 weeks).
Tracking of protocols
Protocols reviewed by the CTRC are tracked on a protocols pending table. These protocols are tracked for progress of process. If a protocol is approved as written, it moves to regulatory tracking.
If requires administrative review or resubmission, the P.I. is reminded at the 1 month mark post CTRC review if no response has been received. (The average response time from a P.I. is 2 weeks). If the P.I. has not responded to a review by the 2nd month mark, the protocol will have to begin the review process again.
Cancer Center’s clinical trials management database (OnCore)
All protocols are given a UAB number, categorized according to the NCI, and entered into the Cancer Center’s centralized database.
Review of amendments
Often amendments are received from the sponsor post CTRC review and approval. All amendments are administratively reviewed and if the amendments are minor, the administrative review will suffice. These are usually administrative-type changes to the protocol. However, if the amendments involve major changes to the protocol (treatment plan, eligibility criteria or study design), it will have to undergo full scientific review at the next CTRC meeting.
Annual Accrual review
Protocols are reviewed for accrual according to their IRB renewal date. An accrual review takes place quarterly to look at the protocols due within this time frame. The past 12 months of accrual are compared with the annual target along with the total accrual. Information provided is the activation date, the annual accrual target, the total number of patients and the patients accrued in the past 12 months. A decision is made at the CTRC meeting to either approve for continuation (accruing to or close to target), allow a 3 or 6 month extension where the P.I. forwards a plan for increasing accrual and then accrual is reviewed at either 3 or 6 months. A study may also be subject to closure if there has been very low or no accrual and the enthusiasm for the trial is low (no plan for increasing accrual submitted as requested) after 3 or 6 months.
Internal Audit
Cancer-related investigator-initiated trials will be subject to internal audit for compliance by the Cancer Center’s Quality Assurance Program.
Protocol Review and Monitoring (PRMS)