Cycle Time Metrics for Multisite Clinical Trials in the United States

Conducting randomized controlled trials entails a prolonged, costly study start-up (SSU) process that may create significant delays. Optimizing the operational aspects of multisite trials requires identifying benchmarks in the SSU process and the potential delays associated with them. We engaged in...

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Bibliographic Details
Published in:Therapeutic Innovation & Regulatory Science 2013-03, Vol.47 (2), p.152-160
Main Authors: Abbott, Diana, Califf, Robert, Morrison, Briggs W, Pierre, Christine, Bolte, Jean, Chakraborty, Swati
Format: Article
Language:English
Subjects:
Clinical trials
Medical equipment
Pharmaceutical industry
Studies
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Summary:Conducting randomized controlled trials entails a prolonged, costly study start-up (SSU) process that may create significant delays. Optimizing the operational aspects of multisite trials requires identifying benchmarks in the SSU process and the potential delays associated with them. We engaged in a collaborative effort to identify and describe key SSU intervals that correspond with necessary procedures and processes for activating multisite clinical trials in the US. After developing definitions for SSU benchmarks and obtaining data from research coordinating entities, we identified factors that were significantly associated with reduced cycle times, including the use of central institutional review boards for study approval and status as a private practice or independent research site. However, small sample sizes and large proportions of missing data hamper the interpretability of our results. Future development of standard measures of SSU efficiency will be critical to analyzing and improving study initiation processes at US research sites.
ISSN:2168-4790
2168-4804
DOI:10.1177/0092861512464371