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. 2017 Mar 15;23(6):1407-1413.
doi: 10.1158/1078-0432.CCR-16-1936. Epub 2016 Nov 16.

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual

Chad Tang  1 , Kenneth R Hess  2 , Dwana Sanders  3 , Suzanne E Davis  4 , Aman U Buzdar  5   6 , Razelle Kurzrock  7 , J Jack Lee  2 , Funda Meric-Bernstam  3 , David S Hong  8
Affiliations

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual

Chad Tang et al. Clin Cancer Res. .

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 matched P < 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 matched P < 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.

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Figures

Fig. 1
Fig. 1
Schematic of core processes necessary for trial activation at MD Anderson Cancer Center and the general flow within the Department of Investigational Cancer Therapeutics to achieve each step.
Fig. 2
Fig. 2
Schematic of team-based staffing models used at (A) the Department of Investigational Therapeutics and (B) a more traditional centralized staffing model.
Fig. 3
Fig. 3
Matched pair analysis comparing trials done within the Department of Investigational Cancer Therapeutics (ICT) and outside that department (non-ICT), analyzing times to complete trial approval hurdles stratified by institutional (A) and industry (B) sponsorship.
Fig. 4
Fig. 4
Matched pair analysis comparing trials done within the Department of Investigational Cancer Therapeutics and outside that department (non-ICT), analyzing participant accrual stratified by institutional (A) and industry (B) sponsorship.
See this image and copyright information in PMC

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