Cycle Time Metrics for Multisite Clinical Trials in the United States

Journal Article

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. © The Author(s) 2013.

Full Text

Duke Authors

Cited Authors

  • Abbott, D; Califf, R; Morrison, BW; Pierre, C; Bolte, J; Chakraborty, S

Published Date

  • 2013

Published In

Volume / Issue

  • 47 / 2

Start / End Page

  • 152 - 160

International Standard Serial Number (ISSN)

  • 0092-8615

Digital Object Identifier (DOI)

  • 10.1177/2168479012464371