Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College Cork, Cork, Ireland.
HRB Trials Methodology Research Network (HRB TMRN), Cork, Ireland.
Trials. 2023 Jul 18;24(1):458. doi: 10.1186/s13063-023-07504-9.
Clinical research nurses are a key part of the clinical trial team but typically get involved later in the trial, usually during recruitment. The purpose of our study was to establish if CRNs who read the trial protocol can predict the performance of the trial.
We randomly selected 18 trial protocols with three statuses, terminated, withdrawn, and completed, from ClinicalTrials.gov, between 2014 and 2018 inclusive. We gave the protocols to five CRNs, asked them to make a judgement and provide a reason for that judgement (via a 12-item questionnaire) on the status of the trial (terminated, withdrawn or completed), if the trial met its recruitment target, if it recruited on time, and if it retained its participants. We also asked if it was likely a CRN was involved in the design of the trial. The CRNs were blinded to the study outcomes, did not receive any training on how to read a protocol and were prohibited from using/abstained from using the internet while completing the task.
Twenty-three questionnaires on 23 trial protocols (18 different trials) were completed by 5 CRNs. The CRNs correctly predicted the trial status 48%, 95% CI: 29-67% (11/23) of the time; successful/unsuccessful recruitment 74%, 95% CI: 54-87% (17/23) of the time; on-time recruitment 70%, 95% CI: 49-84% (16/23) of the time; and participant retention 52%, 95% CI: 33-71% (12/23). CRNs identified 100% (sensitivity) of sites that hit their target and 63%, 95% CI: 36-84% (specificity) of sites that missed their target.
CRNs are very good judges of trial recruitment and site performance issues and are a vital part of the clinical trial team. Taken with the ESP (Estimating Site Performance) study, we have made a strong case for broadening the trial team at the trial design stage. Early engagement of a broad skillset can potentially offset problems of recruitment, retention and trial failure.
临床研究护士是临床试验团队的关键组成部分，但通常在试验后期才参与，通常是在招募阶段。我们的研究目的是确定阅读试验方案的 CRN 是否可以预测试验的表现。
我们随机选择了 18 项 2014 年至 2018 年期间在 ClinicalTrials.gov 上终止、撤回和完成的试验方案，共三个状态。我们将方案交给五名 CRN，要求他们对试验的状态（终止、撤回或完成）、是否达到招募目标、是否按时招募以及是否保留参与者做出判断，并提供判断的理由（通过 12 项问卷）。我们还询问了是否有可能 CRN 参与了试验的设计。CRN 对研究结果不知情，在阅读方案方面没有接受任何培训，在完成任务时被禁止使用/避免使用互联网。
五名 CRN 完成了 23 项试验方案（18 个不同的试验）的 23 份问卷。CRN 正确预测试验状态的概率为 48%，95%CI：29-67%（11/23）；成功/不成功招募的概率为 74%，95%CI：54-87%（17/23）；按时招募的概率为 70%，95%CI：49-84%（16/23）；参与者保留率为 52%，95%CI：33-71%（12/23）。CRN 识别出了 100%（敏感性）达到目标的站点，以及 63%，95%CI：36-84%（特异性）未达到目标的站点。
CRN 是试验招募和站点表现问题的优秀评判者，是临床试验团队的重要组成部分。结合 ESP（估计站点表现）研究，我们已经为在试验设计阶段扩大试验团队提出了强有力的理由。在招募、保留和试验失败方面，尽早引入广泛的技能组合可能会潜在地解决问题。
