Karen Lane , Shannon Hillery , Ryan Majkowski , Bradley J. Barney , Daniel Amirault , Sarah J. Nelson , Mary Bailey , Eun Hea Unsicker , Mary Stroud , Lindsay M. Eyzaguirre , Amy Gawad , Angeline Nanni , Gwendolyn Mirzoyan , Theodora Cohen , Salina P. Waddy , Ken Wiley , Paul A. Harris , Daniel E. Ford , Daniel Hanley , For the Trial Innovation Network
{"title":"使用标准化、自动化的现场评估调查工具(SASI)选择试验中心。","authors":"Karen Lane , Shannon Hillery , Ryan Majkowski , Bradley J. Barney , Daniel Amirault , Sarah J. Nelson , Mary Bailey , Eun Hea Unsicker , Mary Stroud , Lindsay M. Eyzaguirre , Amy Gawad , Angeline Nanni , Gwendolyn Mirzoyan , Theodora Cohen , Salina P. Waddy , Ken Wiley , Paul A. Harris , Daniel E. Ford , Daniel Hanley , For the Trial Innovation Network","doi":"10.1016/j.cct.2024.107583","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>To improve the site selection process for clinical trials, we expanded a site survey to include standardized assessments of site commitment time, team experience, feasibility of tight timelines, and local medical community equipoise as factors that might better predict performance. We also collected contact information about institutional research services ahead of site onboarding.</p></div><div><h3>Aim</h3><p>As a first step, we wanted to confirm that an expanded survey could be feasible and generalizable—that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length.</p></div><div><h3>Methods</h3><p>A standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift.</p></div><div><h3>Results</h3><p>Respondents thought the SASI collected useful and relevant information about their sites (100%). Sites were “comfortable” (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours.</p></div><div><h3>Conclusions</h3><p>Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Selecting trial centers using a standardized, automated site assessment survey instrument (SASI)\",\"authors\":\"Karen Lane , Shannon Hillery , Ryan Majkowski , Bradley J. Barney , Daniel Amirault , Sarah J. Nelson , Mary Bailey , Eun Hea Unsicker , Mary Stroud , Lindsay M. 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We also collected contact information about institutional research services ahead of site onboarding.</p></div><div><h3>Aim</h3><p>As a first step, we wanted to confirm that an expanded survey could be feasible and generalizable—that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length.</p></div><div><h3>Methods</h3><p>A standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift.</p></div><div><h3>Results</h3><p>Respondents thought the SASI collected useful and relevant information about their sites (100%). Sites were “comfortable” (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours.</p></div><div><h3>Conclusions</h3><p>Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.</p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-05-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424001666\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424001666","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Selecting trial centers using a standardized, automated site assessment survey instrument (SASI)
Background
To improve the site selection process for clinical trials, we expanded a site survey to include standardized assessments of site commitment time, team experience, feasibility of tight timelines, and local medical community equipoise as factors that might better predict performance. We also collected contact information about institutional research services ahead of site onboarding.
Aim
As a first step, we wanted to confirm that an expanded survey could be feasible and generalizable—that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length.
Methods
A standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift.
Results
Respondents thought the SASI collected useful and relevant information about their sites (100%). Sites were “comfortable” (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours.
Conclusions
Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.