Applied clinical trials最新文献

{"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":"","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":0.0,"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":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32945506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Clinical Trial Enrollment Methods Through \"Goal Programming\"","authors":"J M Davis,&nbsp;A J Sandgren,&nbsp;A R Manley,&nbsp;M A Daleo,&nbsp;S S Smith","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical trials often fail to reach desired goals due to poor recruitment outcomes, including low participant turnout, high recruitment cost, or poor representation of minorities. At present, there is limited literature available to guide recruitment methodology. This study, conducted by researchers at the University of Wisconsin Center for Tobacco Research and Intervention (UW-CTRI), provides an example of how iterative analysis of recruitment data may be used to optimize recruitment outcomes during ongoing recruitment.</p><p><strong>Study methodology: </strong>UW-CTRI's research team provided a description of methods used to recruit smokers in two randomized trials (<i>n</i> = 196 and <i>n</i> = 175). The trials targeted low socioeconomic status (SES) smokers and involved time-intensive smoking cessation interventions. Primary recruitment goals were to meet required sample size and provide representative diversity while working with limited funds and limited time. Recruitment data was analyzed repeatedly throughout each study to optimize recruitment outcomes.</p><p><strong>Results: </strong>Estimates of recruitment outcomes based on prior studies on smoking cessation suggested that researchers would be able to recruit 240 low SES smokers within 30 months at a cost of $72,000. With employment of methods described herein, researchers were able to recruit 374 low SES smokers over 30 months at a cost of $36,260.</p><p><strong>Discussion: </strong>Each human subjects study presents unique recruitment challenges with time and cost of recruitment dependent on the sample population and study methodology. Nonetheless, researchers may be able to improve recruitment outcomes though iterative analysis of recruitment data and optimization of recruitment methods throughout the recruitment period.</p>","PeriodicalId":89655,"journal":{"name":"Applied clinical trials","volume":"23 6-7","pages":"46-50"},"PeriodicalIF":0.0,"publicationDate":"2014-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4310466/pdf/nihms587276.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33020760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Examining the challenges and solutions to the implementation of trials in resource-limited settings: Limited Resource Trials.","authors":"Christina Blanchard-Horan, Vicki Stocker, Laura Moran, Elaine Okubo Ferguson, Karin L Klingman, Deborah McMahon, Jane Hitti","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":89655,"journal":{"name":"Applied clinical trials","volume":"21 1","pages":"34-42"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3392753/pdf/nihms-352582.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30764482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Collaborative Staffing Model for Multiple Sites: Reducing the challenges of study coordination in complex, multi-site clinical trials.","authors":"Mary E Larkin, Paul McGuigan, Denise Richards, Karen Blumenthal, Kerry Milaszewski, Laurie Higgins, Jill Schanuel, Christen Long","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The implementation of complex, multi-site clinical trials presents challenges that make recruitment efforts, participant follow-up, and organization of staff critical to the success of the overall outcome. This article describes a unique staffing model utilized by the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) study, an NIH (National Institutes of Health) sponsored trial designed to explore treatment options for type 2 diabetes in youth. At each study center, the program coordinator (PC) and diabetes educator (DE) work together to implement the study protocol. A staffing model that provides this type of mutual support for two key members of the study team may decrease the burden customarily encountered solely by the PC in complex trials, and furthermore allows for cross-coverage and flexibility. To determine the degree of overlap and task sharing between the PC and DE across study sites, a self-administered survey was distributed to all PCs and DEs. Survey results as well as specific examples demonstrating an effective collaborative approach by front-line study personnel in managing various challenges encountered in study implementation are included.</p>","PeriodicalId":89655,"journal":{"name":"Applied clinical trials","volume":"20 1","pages":"30-35"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4062294/pdf/nihms268477.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32445555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}