Factors Affecting Workload of Cancer Clinical Trials: Results of a Multicenter Study of the National Cancer Institute of Canada Clinical Trials Group

2002 ◽  
Vol 20 (2) ◽  
pp. 545-556 ◽  
Author(s):  
K. Roche
Keyword(s):  
Clinical Trials ◽  
Multicenter Study ◽  
National Cancer Institute ◽  
Cancer Clinical Trials ◽  
Factors Affecting

Factors Affecting Workload of Cancer Clinical Trials: Results of a Multicenter Study of the National Cancer Institute of Canada Clinical Trials Group

2002 ◽  
Vol 20 (2) ◽  
pp. 545-556 ◽  
Author(s):  
Kathyrn Roche ◽  
Nancy Paul ◽  
Bobbi Smuck ◽  
Marlo Whitehead ◽  
Benny Zee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Collection ◽  
Cancer Treatment ◽  
Multicenter Study ◽  
National Cancer Institute ◽  
Phase Iii ◽  
Study Phase ◽  
Factors Affecting ◽  
Clinical Research Associates

PURPOSE: Increasingly, cancer treatment centers need to be able to estimate specific costs and resources associated with clinical trials. Because the time requirements of trial coordination and data collection are not well known, the Clinical Research Associates (CRA) Committee of the National Cancer Institute of Canada Clinical Trials Group carried out a multicenter study to measure trials’ task times and evaluate the effects of certain factors. METHODS: A data collection instrument was designed and validated before its implementation in the study. Eighty-three CRAs from 24 cancer treatment institutions across Canada collected timing observations of 41 tasks (156 subtasks). Information from all stages of trials activity (protocol management, eligibility and entry, treatment, and follow-up and final stage) was obtained, from initial negotiations to follow-up after study closure. RESULTS: After controlling for stage, phase and sponsor were found to be significant independent factors. Analysis within the stages showed similar patterns. New drug inclusion as a factor was confounded with phase. Industry-sponsored studies had significantly higher overall mean times than did local and cooperative group studies. Early-phase studies required more time than did phase III trials. External sponsorship of any kind increased CRA time more than that necessary for locally coordinated studies, except during the protocol management stage. The burden of a phase I study increased to greater than average once underway and accruing patients. CONCLUSION: Our data demonstrated that sponsor and study phase are important factors to be taken into consideration when estimating clinical trial costs and resource use.

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

2005 ◽  
Vol 23 (22) ◽  
pp. 5247-5254 ◽  
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.

Evaluation of Factors Affecting Awareness of and Willingness to Participate in Cancer Clinical Trials

2005 ◽  
Vol 23 (36) ◽  
pp. 9282-9289 ◽  
Author(s):  
Primo N. Lara ◽  
Debora A. Paterniti ◽  
Christine Chiechi ◽  
Corinne Turrell ◽  
Claudia Morain ◽  
...  
Keyword(s):  
Clinical Trials ◽  
African American ◽  
Family Members ◽  
Information Service ◽  
Third Party ◽  
Cancer Information ◽  
Cancer Clinical Trials ◽  
Willingness To Participate ◽  
Factors Affecting ◽  
Positive Correlations

Purpose Annually, only 3% of patients participate in cancer clinical trials (CCTs). Barriers to accrual include lack of CCT awareness and uncertain third-party payer coverage. In January 2002, a California law (Senate Bill 37 [SB37]) required all third-party payers to reimburse patient care costs related to CCTs. We evaluated the level of awareness of patients and/or their family members/friends regarding CCTs and SB37. Methods We used both a written survey for patients and/or their family members and friends seen in oncology clinics, and a verbal telephone version for Cancer Information Service callers. We tested for correlations between CCT awareness and SB37 knowledge, and willingness to participate in CCTs. Results Of 1,188 respondents, 59% were aware of CCTs, 19% knew of SB37, and 36% were very likely to consider a CCT. There were significant positive correlations between CCT awareness and willingness to participate (P < .001, Spearman), and between SB37 knowledge and willingness to participate (P = .001, Pearson χ2). Reduced awareness was seen in respondents who were either black or African American (odds ratio [OR], 0.44; P = .004), Hispanic (OR, 0.56; P = .03), had an annual income less than $25,000 (OR, 0.38; P < .001), or had less than a college degree (OR, 0.12 to 0.53; P < .001 to .013). Reduced willingness to participate in CCTs was seen in black or African American participants (OR, 0.38; P < .001), Asians (OR, 0.44; P < .006), or respondents aged 18 to 24 years (OR, 0.35; P = .002). Conclusion These results support the hypothesis that improving CCT awareness and SB37 knowledge especially among lower income, less educated, and minority patients, may potentially overcome barriers to participation and subsequently increase accrual in California.

Report from a National Cancer Institute (USA) workshop on quality of life assessment in cancer clinical trials

1992 ◽  
Vol 1 (3) ◽  
pp. 203-210 ◽  
Author(s):  
S. G. Nayfield ◽  
P. A. Ganz ◽  
C. M. Moinpour ◽  
D. F. Cella ◽  
B. J. Hailey
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
National Cancer Institute ◽  
Life Assessment ◽  
Cancer Clinical Trials ◽  
Quality Of Life Assessment
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