Theresa Winhusen1. 1. Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.
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. PURPOSE: 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. LIMITATIONS: 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.
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. PURPOSE: 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. LIMITATIONS: 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: Harry Shamoon; David Center; Pamela Davis; Mendel Tuchman; Henry Ginsberg; Robert Califf; David Stephens; Thomas Mellman; Joseph Verbalis; Lee Nadler; Anantha Shekhar; Daniel Ford; Robert Rizza; Reza Shaker; Kathleen Brady; Barbara Murphy; Bruce Cronstein; Judith Hochman; Philip Greenland; Eric Orwoll; Lawrence Sinoway; Harry Greenberg; Rebecca Jackson; Barry Coller; Eric Topol; Lisa Guay-Woodford; Marschall Runge; Robert Clark; Don McClain; Harry Selker; Curtis Lowery; Steven Dubinett; Lars Berglund; Dan Cooper; Gary Firestein; S Clay Johnston; Julian Solway; James Heubi; Ronald Sokol; David Nelson; Larry Tobacman; Gary Rosenthal; Lauren Aaronson; Richard Barohn; Philip Kern; John Sullivan; Thomas Shanley; Bruce Blazar; Richard Larson; Garret FitzGerald; Steven Reis; Thomas Pearson; Thomas Buchanan; David McPherson; Allan Brasier; Robert Toto; Mary Disis; Marc Drezner; Gordon Bernard; John Clore; Bradley Evanoff; Julianne Imperato-McGinley; Robert Sherwin; Jill Pulley Journal: Clin Transl Sci Date: 2012-03-27 Impact factor: 4.689
Authors: M R Trusheim; A A Shrier; Z Antonijevic; R A Beckman; R K Campbell; C Chen; K T Flaherty; J Loewy; D Lacombe; S Madhavan; H P Selker; L J Esserman Journal: Clin Pharmacol Ther Date: 2016-10-19 Impact factor: 6.875