title: Not getting lost in translational science: A tool for navigating the pre-implementation phase of multi-site pharmacological clinical trials.
abstract: BACKGROUND
  The compelling need to improve the efficiency of multi-site pharmacological clinical trials has received increasing attention and a number of challenges needing to be addressed have been delineated.
  
  
  OBJECTIVE
  The present paper discusses one of the challenges, how to avoid a lengthy pre-implementation phase, and proposes the strategy of using a Pre-implementation Timeline "Calculator." The Calculator is a Microsoft Excel worksheet designed to assist investigators in planning for, and completing, the pre-implementation phase of multi-site pharmacological clinical trials in a timely manner.
  
  
  METHODS
  Preliminary data are presented comparing the pre-implementation phase length of pharmacological trials that did (n=3) and did not (n=4) use the Calculator.
  
  
  RESULTS
  The amount of time taken to complete the stage between having a sponsor-approved protocol and the initiation of recruitment at a study site averaged nine months for the Calculator trials compared to 15 months for the Non-Calculator trials. The period between the Investigators' meeting and the initiation of recruitment at a study site averaged two months for the Calculator trials compared to five months for the Non-Calculator trials. An estimate of the site staffing costs associated with the later time frame was calculated for a hypothetical trial conducted at 10 sites. The results revealed that the extra three months were associated with a cost of $388,000.
  
  
  CONCLUSIONS
  An important limitation of the present paper is the reliance on a sample of convenience for the Calculator and Non-Calculator trials.
  
  
  CONCLUSIONS
  The Calculator is a free, easily implemented, tool that may provide significant benefits in reducing the time and financial resources required to complete the pre-implementation phase of multi-site pharmacological clinical trials; thus, its more wide-spread use in multi-site pharmacological clinical trials seems warranted.
authors.affiliation: Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Winhusen
keywords: clinical trials; efficiency; pharmacological; pre-implementation; translational science