Site engagement for multi-site clinical trials

被引:12
|
作者
Goodlett, Dana [1 ]
Hung, Anna [2 ]
Feriozzi, Ashley [1 ]
Lu, Hien [1 ]
Bekelman, Justin E. [1 ]
Mullins, C. Daniel [3 ]
机构
[1] Univ Penn, Perelman Sch Med, Dept Radiat Oncol, 3400 Civ Ctr Blvd, Philadelphia, PA 19104 USA
[2] Duke Univ, Ctr Informing Hlth Decis, Duke Clin Res Inst, 200 Morris St, Durham, NC 27701 USA
[3] Univ Maryland, Dept Pharmaceut Hlth Serv Res, Sch Pharm, 220 Arch St, Baltimore, MD 21201 USA
关键词
Research engagement; Site engagement; Multi-site clinical trials; Comparative effectiveness research; Clinical trial design; DESIGN;
D O I
10.1016/j.conctc.2020.100608
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Multi-site clinical trials are essential within medical practice to help drive reliable and generalizable knowledge on advancing medical treatments. Although the success of multi-site trials is significantly dependent on local clinician and site research teams, best practices for engagement of site teams, or "site engagement," has not been extensively discussed. Site engagement centers on including sites in the planning and implementation of clinical trials to promote trial enrollment, compliance, and applicability to local contexts. Using a case example from the RadComp Trial, a longitudinal, multi-site clinical trial, novel site engagement practices are provided across three major research phases. In the Planning Phase, site engagement builds partnerships and commitment by active elicitation of information on site specific processes and feedback on trial design. In the Conducting Phase, sustained engagement encourages bi-directional communication and facilitates learning networks for enhanced site performance. In the Dissemination Phase, site and community partnerships are leveraged to create locally designed dissemination plans for broader scientific reach and impact. Site engagement practices discussed in this paper can be replicated or molded for application in other multi-site clinical trials.
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页数:6
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