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.
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.
Authors: Lee D Kaiser; Allen S Melemed; Alaknanda J Preston; Hilary A Chaudri Ross; Donna Niedzwiecki; Gwendolyn A Fyfe; Jacqueline M Gough; William D Bushnell; Cynthia L Stephens; M Kelsey Mace; Jeffrey S Abrams; Richard L Schilsky Journal: J Clin Oncol Date: 2010-10-04 Impact factor: 44.544
Authors: Tamara P Miller; Brian T Fisher; Kelly D Getz; Leah Sack; Hanieh Razzaghi; Alix E Seif; Rochelle Bagatell; Peter C Adamson; Richard Aplenc Journal: Pediatr Blood Cancer Date: 2019-04-09 Impact factor: 3.167
Authors: Tamara P Miller; Yimei Li; Kelly D Getz; Jesse Dudley; Evanette Burrows; Jeffrey Pennington; Azada Ibrahimova; Brian T Fisher; Rochelle Bagatell; Alix E Seif; Robert Grundmeier; Richard Aplenc Journal: Br J Haematol Date: 2017-02-01 Impact factor: 6.998
Authors: Shauna L Hillman; Sumithra J Mandrekar; Brian Bot; Ronald P DeMatteo; Edith A Perez; Karla V Ballman; Heidi Nelson; Jan C Buckner; Daniel J Sargent Journal: J Clin Oncol Date: 2010-05-17 Impact factor: 44.544
Authors: Marko Kavcic; Brian T Fisher; Yimei Li; Alix E Seif; Kari Torp; Dana M Walker; Yuan-Shung Huang; Grace E Lee; Sarah K Tasian; Marijana Vujkovic; Rochelle Bagatell; Richard Aplenc Journal: Cancer Date: 2013-02-21 Impact factor: 6.860
Authors: Tamara P Miller; Yimei Li; Marko Kavcic; Kelly D Getz; Yuan-Shun V Huang; Lillian Sung; Todd A Alonzo; Robert Gerbing; Marla H Daves; Terzah M Horton; Michael A Pulsipher; Jessica Pollard; Rochelle Bagatell; Alix E Seif; Brian T Fisher; Selina Luger; Alan S Gamis; Peter C Adamson; Richard Aplenc Journal: Haematologica Date: 2017-06-22 Impact factor: 9.941