Section 2: ROLES AND RESPONSIBILITIES FOR THE CONDUCT OF QUALITY ASSURANCE PROGRAMS
The Cancer Therapy Evaluation Program (CTEP) has direct oversight responsibilities for the quality assurance and monitoring programs used by the Cooperative Groups, CCOP Research Bases, and CTSU. CTEP staff work closely with the Cooperative Groups and CTSU to design, implement, and evaluate their quality assurance programs. This helps to ensure uniformity across the programs.
2.1 Clinical Trials Monitoring Branch
The CTMB is responsible for establishing guidance for the conduct of quality assurance audits. CTMB provides oversight and monitors compliance of the Cooperative Groups, CCOP Research Bases , and CTSU with the NCI's monitoring guidelines. Compliance with applicable Federal regulations is also monitored by CTMB.
In addition, CTMB staff serve as an educational resource to the cancer research community on issues related to monitoring and regulatory requirements for conducting clinical trials. CTMB staff are responsible for reviewing the scheduling of all audits, for reviewing audit reports and findings, and for assessing the adequacy and acceptability of any corrective actions. To assure consistency in the conduct of on-site audits, CTMB staff or its designee may attend certain on-site audits.
Any data irregularities identified through quality control procedures or through the audit program suggestive of intentional misrepresentation of data must be immediately reported to CTMB. The NCI, if appropriate, may notify other Federal agencies including the Office for Human Research Protections (OHRP), the Office of Research Integrity (ORI)* and the Food and Drug Administration (FDA).
* The proposed regulation as outlined in the Final PHS Policy on Responsible Conduct of Research (RCR) is defined as: "A finding of research misconduct requires that:
- There be a significant departure from accepted practices of the relevant research community; and
- The misconduct be committed intentionally, or knowingly, or recklessly; and
- The allegation be proven by a preponderance of evidence."
2.2 Cooperative Groups
The multicenter nature of Cooperative Group clinical trials presents a variety of challenging methodological problems regarding assurance of quality and consistency in study conduct. The need for formal mechanisms of medical review and quality assurance is obvious. The Cooperative Groups have developed a number of approaches to address these issues.
2.2.1 Quality Control
Quality control is a complex topic spanning the entire range of diagnostic and therapeutic modalities employed by each Cooperative Group. Generalization concerning optimal quality control is impossible. Cost and benefit are obviously important factors in this assessment. The Cooperative Groups have well established quality control procedures defined by their constitutions and by-laws. Some of the items included in these quality control procedures are:
- institutional performance evaluations;
- committees for central review of major elements that impact on the outcome of clinical trials, e.g., pathology, radiotherapy, surgery, and administration of investigational agents; and,
- educational functions which address data collection, data management, and overall data quality.
2.2.2 Study Monitoring
All clinical research carries with it the obligation to ensure optimal therapy for participating patients and optimal conduct of the research such that the patients' participation is meaningful. Accurate and timely knowledge of the progress of each study is a critical Cooperative Group responsibility that includes many of the following elements:
- precise tracking of patient accrual;
- ongoing assessment of patient eligibility and evaluability;
- adequate measures to ensure timely submission of study data;
- adequate measures to ensure timely medical review and assessment of individual patients' data;
- rapid reporting of treatment-related morbidity information; and,
- interim evaluation of outcome measures and patient safety information.
2.2.3 Data and Safety Monitoring
For Phase 3 clinical trials, Cooperative Groups are required to establish Data and Safety Monitoring Committees (DSMCs) that are independent of study leadership, are free of conflicts of interest, and have formal policies and procedures approved by the NCI. The main objectives of the DSMCs are to:
- ensure that patients in the clinical trial are protected;
- ensure that evaluation of interim results and decisions about continuing, modifying, or terminating a clinical trial and reporting results are made competently; and,
- ensure that the credibility of clinical trial reports and the ethics of clinical trial conduct are above reproach.
2.2.4 Monitoring Program
The specific purposes of the monitoring program are to document the accuracy of data submitted to the Cooperative Groups, to verify investigator compliance with protocol and regulatory requirements, and to provide information to institution staff on good clinical practices related to data collection and data management.
2.3 Community Clinical Oncology Program
The CCOPs utilize quality assurance programs similar to those used by the Cooperative Groups. The overall purpose is to ensure that clinical trials conducted by the CCOP components adhere to good clinical practices. A CCOP may have a Cooperative Group or a Cancer Center serve as its research base.
2.3.1 Cooperative Groups
Cooperative Groups follow the same monitoring procedures for CCOPs as they follow for their other members.
2.3.2 Cancer Centers
Cancer Centers that serve as CCOP Research Bases can develop their own quality assurance and monitoring programs as long as they meet the minimum requirements established by the NCI.
2.4 CTSU
The CTSU will facilitate coordination by incorporating audits of CTSU enrolled patient cases into the current Cooperative Group audit mechanisms. CTSU will determine if additional reviewers are needed to augment the team, coordinate the supply of audit materials, and will coordinate and complete the reporting requirements for CTSU enrolled patients. The CTSU will conduct single site audits at institutions that do not belong to Cooperative Groups but have enrolled CTSU protocol patients. The CTSU will operate in accordance with the Guidelines and the Standard Operating Procedures (SOPs) developed by the CTSU. (Appendix 1 PDF)
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