Iskander Renata, Magnan Robart Adele, Moyer Hannah, Nipp Ryan, Gupta Arjun, Kimmelman Jonathan
McGill University, Montreal, Quebec, Canada.
University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma City, OK.
JCO Oncol Pract. 2025 Mar;21(3):391-399. doi: 10.1200/OP.24.00334. Epub 2024 Oct 1.
Participating in phase I cancer clinical trials often entails extra visits and procedures. We describe the planned time and procedures associated with phase I trial participation.
We searched ClinicalTrials.gov for phase I cancer trials of new drugs with assessment schedules and results posted between 2020 and 2022. Trials were included if participants had advanced or metastatic disease. Our primary analysis measured the number of planned research days (PRDs; each day a clinic visit is required) per participant up to the first month of trial participation and for the entire trial duration. Secondarily, we estimated the number of research procedures.
Our sample included 71 phase I trials comprising 302 cohorts. These trials enrolled 3,904 participants; the median participation duration was 2.5 months. During screening and up to the first month of participation, the median PRDs per participant was 7 (IQR, 7-10). Across the entire trial, the median PRDs per participant was 4.5 days per month (IQR, 3.30-6.20). Participants spent 15% of trial days attending planned appointments. Per trial cohort, participants were given a median of 8 (IQR, 7-11) physical examinations, 6 (IQR, 3-10) infusions, 6 (IQR, 3-12) electrocardiograms, and 1 (IQR, 1-3) biopsy.
Participants commit a substantial amount of time to planned visits in phase I cancer trials, especially in the first month. Overall, they invest 15% of trial days attending planned research activities. These estimates provide a lower bound to the time participants in phase I trials donate to drug development, as our analysis excluded unplanned visits.
参与癌症I期临床试验通常需要额外的就诊和检查程序。我们描述了与参与I期试验相关的计划时间和程序。
我们在ClinicalTrials.gov上搜索了2020年至2022年间公布评估时间表和结果的新型药物癌症I期试验。如果参与者患有晚期或转移性疾病，则纳入试验。我们的主要分析衡量了每位参与者在试验参与的第一个月及整个试验期间的计划研究天数（PRD；即每天都需要进行门诊就诊）。其次，我们估计了研究程序的数量。
我们的样本包括71项I期试验，共302个队列。这些试验招募了3904名参与者；中位参与时长为2.5个月。在筛查期间及参与的第一个月，每位参与者的中位PRD为7天（四分位间距，7 - 10天）。在整个试验中，每位参与者的中位PRD为每月4.5天（四分位间距，3.30 - 6.20天）。参与者花费15%的试验天数参加计划内的预约。每个试验队列中，参与者接受的身体检查中位次数为8次（四分位间距，7 - 11次），输液6次（四分位间距，3 - 10次），心电图检查6次（四分位间距，3 - 12次），活检1次（四分位间距，1 - 3次）。
在癌症I期试验中，参与者要投入大量时间进行计划内就诊，尤其是在第一个月。总体而言，他们将15%的试验天数用于参加计划内的研究活动。由于我们的分析排除了非计划内的就诊，这些估计为I期试验参与者为药物研发贡献的时间提供了下限。
