Cancer Related Trials

Introduction

The Fred & Pamela Buffett Cancer Center provides central management and oversight functions for all cancer related trials involving human subjects conducted on campus. This systematic management of cancer related trials is coordinated by the Centralized Protocol Review and Data Management Unit.

Special Review Requirements

All cancer related trials (adult and pediatric) must be reviewed by The Protocol Review and Monitoring System (PRMS) Scientific Review Committee (SRC). The SRC oversees the scientific aspects of cancer-related research involving human subjects conducted by members of the UNMC faculty and students and members of the Fred & Pamela Buffett Cancer Center.

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 IRB responsibilities, which focus on the protection of human subjects.

SRC approval is required before the IRB gives final release or continuation. 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 all internal toxicities and adverse events that occur on therapeutic intervention trials not monitored by an independent board specifically designed for the individual study.

Forms for data and safety monitoring are available on the Fred & Pamela Buffett Cancer Center PRMS website.

Audit Reviews

The PRMS Audit Committee audits all Fred & Pamela Buffett Cancer Center investigator-initiated, multi-center, and other externally peer-reviewed therapeutic intervention trials 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 the Fred & Pamela Buffett Cancer Center, see the FPBCC clinical trials page.

The site links each active trial to information on the ClinicalTrials.gov website.

The PRMS Office also maintains an intranet website which provides Investigators with the most current versions of the SRC, AC, and DSMC Policies and Procedures; Conflict of Interest Policy; submission forms; and meeting dates and submission deadlines.