Fordyce Christopher B, Malone Kaitlin, Forrest Annemarie, Hinkley Terri, Corneli Amy, Topping James, Roe Matthew T
Duke Clinical Research Institute, 2400 Pratt St, Durham, NC, 27705, USA.
Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
Contemp Clin Trials Commun. 2019 Oct 17;16:100462. doi: 10.1016/j.conctc.2019.100462. eCollection 2019 Dec.
The Clinical Trials Transformation Initiative (CTTI) Strengthening the Investigator Community Project was prompted by the need to understand the reasons for high rates of turnover among investigators who lead US Food and Administration-regulated clinical trials at research sites. Because investigator knowledge and experience directly affect the quality and ultimate success of clinical trials, investigator turnover has important implications for the research enterprise, as well as the patients and other stakeholders who depend on the outcomes of clinical research. The CTTI project team used findings from both quantitative and qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to delineate key concerns faced by investigators and recommend practical, action-based solutions. The recommendations focus on strengthening four key categories of site-based research activity: developing site-based research infrastructure and staff, optimizing trial execution and conduct, improving site budget development and contract negotiations, and discovering opportunities for conducting additional trials.
临床试验转化倡议（CTTI）加强研究者群体项目的发起，是因为需要了解在美国食品药品监督管理局监管的研究机构中领导临床试验的研究者更替率高的原因。由于研究者的知识和经验直接影响临床试验的质量和最终成功，研究者更替对研究事业以及依赖临床研究结果的患者和其他利益相关者具有重要影响。CTTI项目团队利用定量和定性研究活动的结果，以及与多个利益相关者的专家会议的意见，来确定研究者面临的关键问题，并推荐切实可行的、基于行动的解决方案。这些建议侧重于加强四类关键的基于机构的研究活动：发展基于机构的研究基础设施和人员、优化试验执行和实施、改善机构预算制定和合同谈判，以及发现开展更多试验的机会。
