title: Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.
abstract: Purpose:Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment.Experimental Design:Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests.Results:We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matchedP< 0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional; all matchedP< 0.05).Conclusions:Use of a clinical research-focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual.Clin Cancer Res; 23(6); 1407-13. ©2016 AACR.
authors.affiliation: Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. CTang1@mdanderson.org dshong@mdanderson.org.
authors.forename: Chad
authors.initials: C
authors.lastname: Tang
authors.affiliation: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Hess
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Dwana
authors.initials: D
authors.lastname: Sanders
authors.affiliation: Department of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Davis
authors.affiliation: Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.|Office of Vice Provost for Clinical and Interdisciplinary Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Aman U
authors.initials: AU
authors.lastname: Buzdar
authors.affiliation: Division of Hematology and Oncology, Center for Personalized Therapy, University of San Diego, La Jolla, California.
authors.forename: Razelle
authors.initials: R
authors.lastname: Kurzrock
authors.affiliation: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Funda
authors.initials: F
authors.lastname: Meric-Bernstam
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. CTang1@mdanderson.org dshong@mdanderson.org.
authors.forename: David S
authors.initials: DS
authors.lastname: Hong
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D012042:Registries