Cancer Related Trials
Introduction
The Fredoncology &Clinical PamelaTrials BuffettOffice Cancer Center(CTO) provides central management and oversight functions for all cancer cancer-related trials involvingthat involve human subjects conducted on campus. ThisThe systematicCTO managementis staffed by project coordinators, research nurse coordinators, clinical research assistants, data coordinators, and quality assurance personnel. The CTO staff work alongside the Oncology/Hematology factulty to implement and oversee a diverse range of cancer relatedclinical trials isincuding coordinatedinvestigator-initiated, byindustry-sponsored, thenational Centralizedcooperative Protocol Reviewgroup, and Dataconsortium Management Unit.trials.
Special Review Requirements
The SRC is responsible for:
- evaluating all new and amended clinical research protocols for scientific merit and to ensure that there are adequate resources available to successfully complete the proposed research
- monitoring accrual to active protocols to ensure that studies meet their accrual goals and to require a reassessment of recruitment strategies and accrual goals when necessary
- ensuring that there are no competing studies with overlapping eligibility criteria for a specific disease indication
- establishing priority of each protocol based on National Cancer Institute guidelines and institutional priorities
- performing ongoing annual scientific review of cancer center protocols
The function of the SRC is complementary to the Institutional Review Board (IRB) and does not duplicate IRBthe IRB's responsibilities, which focusfocuses on the protection of human subjects.
SRC approval is required before the IRB gives final releaseapproval or continuation.continuation of a protocol submission. If the investigator fails to obtain SRC approval prior to expiration of the IRB approval period, the protocol will be classified as “approval expired” until all requirements are met. Forms for protocol submission are available on the Fred & Pamela Buffett Cancer Center PRMS website.
Data and Safety Monitoring Support
Data and Safety Monitoring
The standing Cancer Center Data and Safety Monitoring Committee (DSMC) monitors allthe internalsafety toxicitiesof andresearch adverseparticipants eventsenrolled that occur onin therapeutic interventioninterventional clinical research trials not monitoredsponsored by anUNMC independentfaculty boardas specificallyoutlined designed forin the individualUNMC study.Data Safety Monitoring Plan (DSMP).
Forms for data and safety monitoring are available on the Fred & Pamela Buffett Cancer Center PRMS website.
Audit Reviews
The PRMS Audit Committee (AC) performs audits and provides oversight on all Fred & Pamela Buffett Cancer Center investigator-initiated, multi-center, and other externally peer-reviewedinitiated therapeutic interventioninterventional trials with UNMC as the study source (i.e. sponsor). The role of the Audit Committee is to ensure:
- compliance with institutional regulatory guidelines
- confirmation of patient eligibility
- adherence to treatments
- appropriateness of adverse event monitoring and reporting; and 5) adequacy of patient follow-up as stipulated in the protocol.
Staff from the two clinical units; the Early Phase Therapeutic Clinical Trial Unit and Adult Hematology/Oncology Section, are available to assist researchers in all aspects of cancer related clinical trials.
For a list of all active cancer related clinical trials conducted at theUNMC, Fred & Pamela Buffett Cancer Center, seevisit the FPBCCcancer-related clinical trials page.
The site links each active trial to information on the ClinicalTrials.gov website.
The PRMS Office also maintains an intranet website is a useful resource which provides Investigatorsinvestigators with the most current versions of the SRC, AC,DSMC, and DSMCAC Policies and Procedures; Conflict of Interest Policy; submission forms; and meeting dates and submission deadlines.