Cooperative Group Cancer Clinical Trials: An NCIC Clinical Trials Group

6557 Background: Observations at the authors’ institutions and by Dilts et al (JCO 2008, abstr 6534) indicate a high percentage of industry (IND)- and cooperative group (CG)-sponsored therapeutic clinical trials (TCTs) with minimal enrollment. We observed most of the enrollment from a small proportion of the TCTs. To determine if this data was representative of other cancer centers (CCs) we examined accrual to IND- and CG-sponsored adult TCTs from 14 CCs. Methods: Accrual data to IND- and CG-sponsored TCTs was obtained from 14 U.S. CCs. Data for the 3-year period from 2005 through 2007 was analyzed. Pediatric TCTs were excluded. Results: Of 2,685 TCTs, 1455 (54.2%) did not accrue any patients (pts). Only 713 (26.6%) TCTs enrolled > 2 pts and these TCTs provided 88.8% of the total enrollment. Resource utilization: We estimate > 230,000 hours (median: 3,773 hours per CC per year) were devoted to study start up and regulatory maintenance for the 1,455 TCTs that did not accrue any pts (Guidance Document for Implementing Effective Cancer Clinical Trials, www.c-changetogether.org/pubs/default.asp). Conclusions: Approximately 90% of the accrual to IND and CG TCTs is from 26% of these TCTs. Significant resources are used on TCTs that do not contribute significantly to overall accrual. Effective rules governing selection of IND and CG TCTs for activation are needed. Effective rules will enable centers to re-direct valuable resources to useful activities without adverse effect on overall enrollment. [Table: see text] No significant financial relationships to disclose.

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Value of information analyses for real-time prioritization decisions within a cancer clinical trials cooperative group.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.15_suppl.6506 ◽

2015 ◽

Vol 33 (15_suppl) ◽

pp. 6506-6506

Author(s):

Caroline Savage Bennette ◽

Scott David Ramsey ◽

David Leroy Veenstra ◽

Anirban Basu ◽

Josh John Carlson

Keyword(s):

Clinical Trials ◽

Real Time ◽

Value Of Information ◽

Cancer Clinical Trials ◽

Cooperative Group

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Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

Journal of Clinical Oncology ◽

10.1200/jco.2007.11.3324 ◽

2007 ◽

Vol 25 (32) ◽

pp. 5051-5057 ◽

Cited By ~ 51

Author(s):

Deborah Watkins Bruner ◽

Charlene J. Bryan ◽

Neil Aaronson ◽

C. Craig Blackmore ◽

Michael Brundage ◽

...

Keyword(s):

Clinical Trials ◽

Patient Reported Outcomes ◽

Online Survey ◽

Cancer Control ◽

The United States ◽

Cancer Clinical Trials ◽

Cooperative Group ◽

Cooperative Groups ◽

End Points ◽

Patient Reported

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

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Increasing Minority Participation in Cancer Clinical Trials: The Minority-Based Community Clinical Oncology Program Experience

Journal of Clinical Oncology ◽

10.1200/jco.2005.22.236 ◽

2005 ◽

Vol 23 (22) ◽

pp. 5247-5254 ◽

Cited By ~ 56

Author(s):

Worta McCaskill-Stevens ◽

Martha M. McKinney ◽

Cynthia G. Whitman ◽

Lori M. Minasian

Keyword(s):

Clinical Trials ◽

Temporal Trends ◽

Cancer Clinical Trials ◽

Cooperative Group ◽

Factors Affecting ◽

Treatment Trials ◽

Minority Participation ◽

Minority Enrollment ◽

Community Clinical Oncology Program ◽

Major Factors

Purpose The National Cancer Institute's (NCI) Minority-Based Community Clinical Oncology Program (MBCCOP) seeks to enhance minority participation in cancer clinical trials by building clinical trials outreach and management capacity in healthcare institutions serving large numbers of minority cancer patients. This article examines temporal trends in MBCCOP accruals to cancer prevention and control (CP/C) and cancer treatment trials and the racial distribution of study participants, along with the major factors affecting minority enrollment. Methods We used NCI databases to analyze temporal trends in overall accruals and accruals by race. We analyzed transcripts from an NCI-sponsored meeting with MBCCOP principal investigators and data from a follow-up survey to identify factors affecting minority enrollment. Results Between 1992 and 2003, annual patient accruals to treatment trials increased 39% despite little change in the number of MBCCOP grantees. During this same period, annual participant accruals to CP/C trials more than doubled. Between 1995 and 2003, minorities comprised 51% to 67% of the MBCCOP patients accrued to cooperative group treatment trials compared with ≤ 23% of the patients accrued by other cooperative group members and affiliates. Major factors affecting minority enrollment include the availability of “clinically relevant” protocols, regulatory requirements, characteristics of the patient population, and the level of support from sponsoring institutions and community physicians. Conclusion MBCCOPs have demonstrated their ability to facilitate the participation of racial/ethnic minorities in clinical trials. However, the contributions that they could make to the design and conduct of minority-focused research studies merit further exploration.

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