Protocol Review and Monitoring

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Linked publications, trials & patents

Abstract

The primary goal of the Protocol Review and Monitoring System (PRMS) is to ensure that all human subjects research is of the highest scientific quality. This resource is available to over 1300 faculty members. Over the past 5 years, on average annual 542 faculty members utilized the PRMS and participated in human subjects research each year. PRMS is supported by 29 staff members under the direction of Dr. Maurie Markman, Vice President for Clinical Research. The core function of the PRMS is to provide a mechanism to assure adequate internal oversight of the scientific and research aspects of all institutional clinical trials. The focus is to review the scientific merit, progress, and priorities of the clinical research protocols conducted by the faculty. This function is coordinated by PRMS as a single source of service, support and oversight. The PRMS is made of up several subcommittees that are designated to provide scientific review and approval for new research protocols, as well as monitor the progress of the protocols. During the last five years, new services provided include a function that allows Regulatory Specialists to review new submissions for format and completeness of information and either reject or accept the submissions electronically. This includes the use of a specialized electronic information sheet (a resubmission memo) that lists amendments made prior to resubmitting the revised protocol document. This is a valuable tool that is also used during the review process when a protocol is initially submitted. The electronic review document provided by each assigned reviewer during the scientific review process can be compared to this resubmission memo to ensure all items of concern have been addressed by the investigator. Additionally, the electronic protocol eligibility, abstract, and informed consent documents for all trials that have been submitted through the PDOL are made available on an intranet web page that is accessible by the patient care units. The navigational web page provides protocol status information as well, including when a protocol has been closed to new subject accrual. This allows caregivers to have ready access to current protocol information from time of activation, during new subject accrual and treatment though completion of the protocol. This information is provided in real time and no delays occur after regulatory approval of the protocol. During the last fiscal year, the funds used to support the PRMS function were $246,418 (15%) from the Cancer Center Support Grant (CCSG), $172,163 (10%) from user fees, and $1,259,771 (75%) from the institution. It is projected that in the next award cycle, the increase in support provided by the CCSG will alter the sources of funds such that the percentages provided by the CCSG ($258,228), the user fees ($286,937) and the institution ($1,526,868), will be 12%, 14% and 74%, respectively. The PRMS supported 2739 protocols from 599 cancer center members, of which 81% hold peer-reviewed funding. During the last several years, the number of new protocols managed by PRMS has remained constant. Protocols that do not meet the UTMDACC scientific standards are typically withdrawn from submission and review. While the volume of protocols has not increased, the activity involved in oversight has become increasingly more detailed due to the evolution of regulatory requirements.