Sponsor-involved statistical analyses in Phase III cancer clinical trials

TY - JOUR

T1 - Sponsor-involved statistical analyses in Phase III cancer clinical trials

AU - Abi Jaoude, Joseph

AU - Kouzy, Ramez

AU - Minsky, Bruce D.

AU - Fuller, Clifton David

AU - Yuan, Ying

AU - Do, Kim Anh

AU - Taniguchi, Cullen M.

AU - Ludmir, Ethan B.

N1 - Funding Information: We would like to thank all the patients and families that were enrolled in the trials analyzed. Dr Fuller received/receives funding and salary support unrelated to this project during the period of study execution from the National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Research Education Programs for Residents and Clinical Fellows Grant (R25EB025787-01); the National Institute for Dental and Craniofacial Research Establishing Outcome Measures Award (1R01DE025248/R56DE025248) and Academic Industrial Partnership Grant (R01DE028290); NCI Early Phase Clinical Trials in Imaging and Image-Guided Interventions Program (1R01CA218148); an NIH/NCI Cancer Center Support Grant (CCSG) Pilot Research Program Award from the UT MD Anderson CCSG Radiation Oncology and Cancer Imaging Program (P30CA016672); an NIH/NCI Head and Neck Specialized Programs of Research Excellence (SPORE) Developmental Research Program Award (P50 CA097007); NIH Big Data to Knowledge (BD2K) Program of the National Cancer Institute (NCI) Early Stage Development of Technologies in Biomedical Computing, Informatics and Big Data Science Award (1R01CA2148250; National Science Foundation (NSF), Division of Mathematical Sciences, Joint NIH/NSF Initiative on Quantitative Approaches to Biomedical Big Data (QuBBD) Grant (NSF 1557679); NSF Division of Civil, Mechanical and Manufacturing Innovation (CMMI) grant (NSF 1933369); and the Sabin Family Foundation. Direct infrastructure support is provided to Dr. Fuller by the multidisciplinary Stiefel Oropharyngeal Research Fund of the University of Texas MD Anderson Cancer Center Charles and Daneen Stiefel Center for Head and Neck Cancer and the Cancer Center Support Grant (P30CA016672) and the MD Anderson Program in Image-guided Cancer Therapy. Dr Fuller has received direct industry grant support, honoraria, and travel funding from Elekta AB unrelated to this project. Dr Yuan served as a consultant to Abbvie, Amgen, Boehringer Ingelheim Pharmaceuticals, Bristol Myers Squibb, Midas Medical Technologies, Servier Pharmaceuticals, Starpax, Vertex Pharmaceuticals. Dr Taniguchi is supported by funding from NIH under award R01CA227517-01A1, Cancer Prevention & Research Institute of Texas (CPRIT) grant RR140012, V Foundation (V2015-22), the Kimmel Foundation, Sabin Family Foundation Fellowship and the McNair Foundation. Funding Information: We would like to thank all the patients and families that were enrolled in the trials analyzed. Dr Fuller received/receives funding and salary support unrelated to this project during the period of study execution from the National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Research Education Programs for Residents and Clinical Fellows Grant (R25EB025787‐01); the National Institute for Dental and Craniofacial Research Establishing Outcome Measures Award (1R01DE025248/R56DE025248) and Academic Industrial Partnership Grant (R01DE028290); NCI Early Phase Clinical Trials in Imaging and Image‐Guided Interventions Program (1R01CA218148); an NIH/NCI Cancer Center Support Grant (CCSG) Pilot Research Program Award from the UT MD Anderson CCSG Radiation Oncology and Cancer Imaging Program (P30CA016672); an NIH/NCI Head and Neck Specialized Programs of Research Excellence (SPORE) Developmental Research Program Award (P50 CA097007); NIH Big Data to Knowledge (BD2K) Program of the National Cancer Institute (NCI) Early Stage Development of Technologies in Biomedical Computing, Informatics and Big Data Science Award (1R01CA2148250; National Science Foundation (NSF), Division of Mathematical Sciences, Joint NIH/NSF Initiative on Quantitative Approaches to Biomedical Big Data (QuBBD) Grant (NSF 1557679); NSF Division of Civil, Mechanical and Manufacturing Innovation (CMMI) grant (NSF 1933369); and the Sabin Family Foundation. Direct infrastructure support is provided to Dr. Fuller by the multidisciplinary Stiefel Oropharyngeal Research Fund of the University of Texas MD Anderson Cancer Center Charles and Daneen Stiefel Center for Head and Neck Cancer and the Cancer Center Support Grant (P30CA016672) and the MD Anderson Program in Image‐guided Cancer Therapy. Dr Fuller has received direct industry grant support, honoraria, and travel funding from Elekta AB unrelated to this project. Dr Yuan served as a consultant to Abbvie, Amgen, Boehringer Ingelheim Pharmaceuticals, Bristol Myers Squibb, Midas Medical Technologies, Servier Pharmaceuticals, Starpax, Vertex Pharmaceuticals. Dr Taniguchi is supported by funding from NIH under award R01CA227517‐01A1, Cancer Prevention & Research Institute of Texas (CPRIT) grant RR140012, V Foundation (V2015‐22), the Kimmel Foundation, Sabin Family Foundation Fellowship and the McNair Foundation.

PY - 2020/12/15

Y1 - 2020/12/15

KW - FDA

KW - biostatistician

KW - clinical trials

KW - industry

KW - oncology

UR - http://www.scopus.com/inward/record.url?scp=85087690565&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85087690565&partnerID=8YFLogxK

U2 - 10.1002/ijc.33180

DO - 10.1002/ijc.33180

M3 - Letter

C2 - 32621758

AN - SCOPUS:85087690565

SN - 0020-7136

VL - 147

SP - 3579

EP - 3581

JO - International journal of cancer

JF - International journal of cancer

IS - 12

ER -