The Protocol Review and Monitoring System (PRMS) continues to have as its major goal the assurance of the quality of the clinicaL research at the M.D. Anderson Cancer Center. PRMS consists of three major elements. Fist, the Clinical Research Committee and Psychosocial, Behavioral and Health Services Research Committee review the scientific aspects of protocols. This review includes the determination of validity of the scientific question, the appropriateness of the design of the study, the applicability of the proposed biostatistical methods of analysis, and the feasibility of the study reaching its state objectives. Second, the Protocol Data Management System (PDMS) must be used to register all patients of clinical trials. An eligibility checklist must be successfully completed prior to patient registration and release of drug from the pharmacy. Thus, a single database now exists in which clinical trials patient information is deposited for review and audit. Third, the Office of Clinical Research Quality Assurance audits the performance of the trial with the approved protocol and the agreement of the PDMS database with the patient record (two random audits per month). Thus, critical elements of the Clinical Trials Support Resource Core constitute the various checkpoints for PRMS process. Protocol prioritization remains the responsibility of the clinical departments. This is because the major expertise for prioritization of disease-specific protocols resides in these departments. However, the committees reviewing the scientific of proposals can disapprove or make approval contingent upon appropriate prioritization of protocols at any time during the review process. Further, the Office of Clinical Research Quality Assurance has received investigators' requests to close over 100 protocols following a detailed review of accrual done by that office. This is a regular, on-going activity of this office (every 6 months). Using this three-part system, we have developed a PRMS that assures the highest standards of peer-reviewed clinical research, a system of random audits, and an institution-wide database that allows auditing and data monitoring functions to occur rapidly and with minimal disruption to on- going work.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
3P30CA016672-26S2
Application #
6506691
Study Section
Project Start
2001-09-28
Project End
2002-06-30
Budget Start
Budget End
Support Year
26
Fiscal Year
2001
Total Cost
Indirect Cost
Name
University of Texas MD Anderson Cancer Center
Department
Type
DUNS #
001910777
City
Houston
State
TX
Country
United States
Zip Code
77030
Ma, Grace X; Lee, Minsun M; Tan, Yin et al. (2018) Efficacy of a community-based participatory and multilevel intervention to enhance hepatitis B virus screening and vaccination in underserved Korean Americans. Cancer 124:973-982
Peng, Guang; Mills, Gordon B (2018) Surviving Ovarian Cancer: An Affair between Defective DNA Repair and RB1. Clin Cancer Res 24:508-510
Radovich, Milan; Pickering, Curtis R; Felau, Ina et al. (2018) The Integrated Genomic Landscape of Thymic Epithelial Tumors. Cancer Cell 33:244-258.e10
Tetzlaff, Michael T; Nelson, Kelly C; Diab, Adi et al. (2018) Granulomatous/sarcoid-like lesions associated with checkpoint inhibitors: a marker of therapy response in a subset of melanoma patients. J Immunother Cancer 6:14
Tayob, Nabihah; Richardson, Peter; White, Donna L et al. (2018) Evaluating screening approaches for hepatocellular carcinoma in a cohort of HCV related cirrhosis patients from the Veteran's Affairs Health Care System. BMC Med Res Methodol 18:1
Caruso, Joseph A; Duong, Mylinh T; Carey, Jason P W et al. (2018) Low-Molecular-Weight Cyclin E in Human Cancer: Cellular Consequences and Opportunities for Targeted Therapies. Cancer Res 78:5481-5491
Yu, Wangie; Chen, Yunyun; Dubrulle, Julien et al. (2018) Cisplatin generates oxidative stress which is accompanied by rapid shifts in central carbon metabolism. Sci Rep 8:4306
Tanco, Kimberson; Azhar, Ahsan; Rhondali, Wadih et al. (2018) The Effect of Message Content and Clinical Outcome on Patients' Perception of Physician Compassion: A Randomized Controlled Trial. Oncologist 23:375-382
Elimova, Elena; Wang, Xuemei; Qiao, Wei et al. (2018) Actionable Locoregional Relapses after Therapy of Localized Esophageal Cancer: Insights from a Large Cohort. Oncology 94:345-353
Hoadley, Katherine A; Yau, Christina; Hinoue, Toshinori et al. (2018) Cell-of-Origin Patterns Dominate the Molecular Classification of 10,000 Tumors from 33 Types of Cancer. Cell 173:291-304.e6

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