{"title":"Not getting lost in translational science: A tool for navigating the pre-implementation phase of multi-site pharmacological clinical trials.","authors":"Theresa Winhusen","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Limitations: </strong>An important limitation of the present paper is the reliance on a sample of convenience for the Calculator and Non-Calculator trials.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":89655,"journal":{"name":"Applied clinical trials","volume":"23 8-9","pages":"36-39"},"PeriodicalIF":0.0000,"publicationDate":"2014-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278662/pdf/nihms-637015.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Applied clinical trials","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.
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