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Not Getting Lost in Translational Science: A Tool for Navigating the Pre-Implementation Phase of Multi-Site Pharmacological Clinical Trials.

Applied Clinical Trials 2014;23:36-39.

Therea M. Winhusen, PhD (University of Cincinnati/CinARC, OV Node).

The goal of streamlining translational science, of which streamlining multi-site clinical trials is a component, is of critical importance. Achieving this goal will entail the dedication of many investigators and will entail scientific breakthroughs, as well as attention to factors that, while mundane, can have a significant impact on the speed with which promising pharmacological treatments reach patient care. This paper addresses one challenge to the efficient completion of multi-site clinical trials: the relatively long period of time that it can take to complete the pre-implementation phase, the phase between sponsor approval of a protocol and initiation of recruitment. 

A long pre-implementation phase is problematic in that it can significantly increase the costs of conducting the trial and reduce the speed with which findings are available, and hence, their potential relevance.   The Pre-Implementation Timeline Calculator, a tool developed in working with the National Drug Abuse Treatment Clinical Trials Network (CTN), is designed to help investigators plan for and complete the pre-implementation phase in a more timely manner.

Preliminary data suggest that using this tool may significantly reduce the time and financial resources required for pre-implementation. An important limitation of the present data is the reliance on a sample of convenience for the Calculator and Non-Calculator trials. However, investigators who have completed multi-site pharmacological trials have access to the length of the pre-implmentation phase for their trials and, thus, can determine whether the use of a tool like the Pre-Implementation Timeline Calculator may lead to time and cost savings. In general, given that the Calculator has no discernible disadvantages, its more widespread use in multi-site pharmacological clinical trials seems warranted. (Article (Peer-Reviewed), PDF, English, 2014)

Keywords: Adoption of interventions | Research design | Applied Clinical Trials (journal)

Document No: 1054, PMID: 25554724, PMCID: PMC4278662,

Submitted by CTN Dissemination Librarians, 3/31/2014.

Winhusen, Theresa M. mail

Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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Updated 8/2015 --