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Estimation of Cancer Progression Based Clinical Trial Subgroups
Shankar Srinivasan1, Lihua Yue2 and Weiyuan Chung2
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DOI:10.17265/2159-5291/2019.05.002
1. Partner, Resource Tepee LLC and Director, Celgene Corporation, 2. Associate Director, Biostatistics, Celgene Corporation.
Cancer trials often start investigational therapy at diagnosis or after a selected number of relapses. These are the usual core inclusion criteria in clinical trials. Hence it is helpful when planning a trial to know the likely percentages of patients receiving standard therapy at clinics and hospitals who meet this key inclusion criteria of being newly diagnosed during a period or having just had their first, second or third relapse during an anticipated enrollment time frame. Often regulatory agencies will have approvals tied to the use of a therapy in a relapsed context or in a newly diagnosed context. We provide details on calculations to help those in clinical trial operations make realistic assessments on the number of sites and likely enrollment at clinical trial sites, and the enrollment time frames that might be needed to complete planned total patient enrollment. The estimates complement site feasibility questionnaires which are often sent to gauge patient availability and site interest.
Clinical trial enrollment, site feasibility, progression/relapse based subgroups.
Srinivasan S., Lihua Y., Weiyuan C. 2019. “Estimation of Cancer Progression Based Clinical Trial Subgroups” Journal of Mathematics and System Science 9: 124-9.
[1] Castellino, A., Chiappella, A., LaPlant, B. R., et al. 2018. “Lenalidomide plus R-CHOP21 in Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL): Long-Term Follow-Up Results from a Combined Analysis from Two Phase 2 Trials.” Blood Cancer J. 8 (11): 108. doi: 10.1038/s41408-018-0145-9D.
[2] O’Brien, S., Furman, R. R., Coutre, S., et al. 2018. “Single-Agent Ibrutinib in Treatment-Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia: A 5-Year Experience.” Blood 131: 1910-9.
[3] Burgess, L. J., Burgess, L. J., and Sulzer, N. U. 2011. “Examining the Clinical Trial Feasibility Process and Its Implications for a Trial Site.” Journal of Clinical Trials 3: 51-4. doi:10.2147/OAJCT.S23631.
[4] Jagannath, S., Rifkin, R. M., Gasparetto, C., et al. 2018. “Development of a Predictive Model of Multiple Myeloma (MM) Patient Outcomes Based on Treatment Sequencing Using Data from The Connect® MM Patient Registry.” Blood 132: 3232.
[5] Calculator at https://resourcetepee.com/free-statistical-calculators/trial-enrollment/estimating-clinical-trial-enrollment-eligible-subsets-in-oncology/.
[6] Srinivasan, S. S. “Details on the Estimation of Cancer Progression Based Enrollment Subgroups.” Technical Report on Research Gate, doi: 10.13140/RG.2.2.33118.48963.
[7] Collett, D. 2003. Modelling Survival Data in Medical Research, 2nd ed. Boca Raton, Florida: Chapman and Hall/CRC.
[8] Kline, M. 1976. CALCULUS: An Intuitive and Physical Approach. Mineola, New York: Dover Publications.