Bruneau Beau, Surdam Kristin, Bland Amy, Krueger Amy, Wise Andrew, Cotarlan Ani, Leviton Asher, Jouravleva Elena, Fitzgerald Grace, Frost Heather N, Cutler Honora F, Buddle Joshua, Diaz Luis G, Cohen Michele, Sacco Nancy A, Washington Ryan, Mauermann Susan, Chen Victor, Bastek Andrea
Florence Healthcare, USA.
KOL & Strategy, Florence Healthcare, USA.
Contemp Clin Trials Commun. 2024 May 31;40:101291. doi: 10.1016/j.conctc.2024.101291. eCollection 2024 Aug.
This Site Feasibility Task Force convened to assess the complex and burdensome process of site feasibility in clinical trials. The objective was to create mutual understanding of challenges and provide suggestions for improving collaboration among sponsors, contract research organizations (CROs), and sites.
The task force was composed of representatives from sponsors, CROs and sites (43 % Sites, 20 % Site Networks, 10 % Small/mid-size sponsors, 10 % Small/mid-size CROs, 10 % Large sponsors, 7 % Large CROs). The group collaborated to define the scope of the problem, identify challenges in the current process, and provide suggestions for improving the process.
The group found there is a need for better differentiation between the three main stages of feasibility, and the four sub-phases of Site Feasibility. The discussion brought to light emerging trends like early initiation of Site Feasibility and premature engagement of sites by CROs. To fully explain these challenges, the group analyzed the current practices and documented their downstream impact on clinical trial execution for all stakeholders. A list of best practices emerged naturally from this analysis. These findings are aggregated into short and actionable best practice guides.
The task force suggests practical changes for the feasibility process and raises awareness of emerging trends and their associated risks. This awareness can begin to drive change in the site feasibility process, although industry-wide transformation will require new levels of collaboration, data standardization and automation tools. The potential benefits of evolving this process are significant and meaningful for more efficient and successful clinical trials.
本现场可行性特别工作组召开会议，以评估临床试验中复杂且繁琐的现场可行性流程。目的是促进各方对挑战达成共识，并为改善申办方、合同研究组织（CRO）和研究现场之间的合作提供建议。
特别工作组由申办方、CRO和研究现场的代表组成（43%为研究现场、20%为现场网络、10%为中小型申办方、10%为中小型CRO、10%为大型申办方、7%为大型CRO）。该小组共同协作，界定问题范围，确定当前流程中的挑战，并为改进流程提供建议。
该小组发现，需要更好地区分可行性的三个主要阶段以及现场可行性的四个子阶段。讨论揭示了一些新出现的趋势，如现场可行性的早期启动以及CRO过早让研究现场参与。为充分解释这些挑战，该小组分析了当前的做法，并记录了其对所有利益相关者临床试验执行的下游影响。从这一分析中自然产生了一份最佳实践清单。这些发现被汇总成简短且可操作的最佳实践指南。
特别工作组针对可行性流程提出了切实可行的改进建议，并提高了对新出现趋势及其相关风险的认识。这种认识可推动现场可行性流程的变革，尽管全行业的转型将需要新的合作水平、数据标准化和自动化工具。改进这一流程的潜在益处对于更高效、成功的临床试验而言意义重大。
