Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Centre of Evidence-Based Orthopaedics, McMaster University, Hamilton, Ontario, Canada.
Trials. 2021 Mar 20;22(1):219. doi: 10.1186/s13063-021-05149-0.
The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) randomized controlled trial (RCT) was the first study to prospectively enroll and randomize orthopedic oncology patients in multiple centers internationally. The objective of this study was to describe recruitment patterns, to examine the differences in enrollment across different PARITY sites, and to identify variables associated with differing levels of recruitment.
Data from this study was obtained from the PARITY trial Methods Center and records of correspondence between the Methods Center and recruiting sites. We performed descriptive statistics to report the recruitment patterns over time. We compared recruitment, time to set up, and time to enroll the first patient between North American and international sites, private and public healthcare models, and the presence or absence of research personnel. Two-tailed non-paired t tests were performed to test average monthly recruitment rates between groups.
A total of 602 patients from 36 North American and 12 international sites were recruited from 2013 to 2019. North American sites were able to become fully enrollment-ready at an average of 19.5 months and international sites at an average of 27 months. Once enrolling, international sites were able to enroll 0.59 patients per/month whereas North American sites averaged a monthly recruitment rate of 0.2 patients/month once enrolling. Sites with research personnel reached enrollment-ready status at an average of 19.3 months and sites without research support at an average of 30.3 months. Once enrolling, the recruitment rate was 0.28 patients/month and 0.2 patients per month for sites with and without research support, respectively. Publicly funded sites had a monthly enrollment of 0.4 patients/month whereas privately funded sites had a monthly enrollment rate of 0.17 patients/month.
As a collaborative group, the PARITY investigators increased the pace of recruitment throughout the trial, likely by increasing the number of active sites. The longer time to start-up at international sites may be due to the complex governing regulations of pharmaceutical trials. Nevertheless, international sites should be considered essential as they recruited significantly more patients per month once active. The absence of research support personnel may lead to delays in the time to start-up. The results of the current study will provide guidance for choosing which sites to recruit for participation in future collaborative clinical trials in orthopedic oncology and other surgical specialties.
ClinicalTrials.gov NCT01479283 . Prospectively registered on November 24, 2011.
肿瘤外科预防性抗生素方案（PARITY）随机对照试验（RCT）是第一项前瞻性招募和随机分组的多中心国际骨科肿瘤学患者的研究。本研究的目的是描述招募模式，检查不同 PARITY 站点之间的入组差异，并确定与不同招募水平相关的变量。
本研究的数据来自 PARITY 试验方法中心和方法中心与招募站点之间的通信记录。我们进行了描述性统计，以报告随时间推移的招募模式。我们比较了北美和国际站点、私人和公共医疗保健模式以及是否有研究人员之间的招募、建立时间和招募第一个患者的时间。采用双尾非配对 t 检验比较组间平均每月招募率。
2013 年至 2019 年期间，从 36 个北美和 12 个国际站点共招募了 602 名患者。北美站点平均 19.5 个月达到完全入组准备状态，国际站点平均 27 个月达到入组准备状态。一旦入组，国际站点每月可入组 0.59 名患者，而北美站点每月平均入组 0.2 名患者。有研究人员的站点平均 19.3 个月达到入组准备状态，无研究支持的站点平均 30.3 个月达到入组准备状态。一旦入组，有研究支持的站点招募率为 0.28 名患者/月，无研究支持的站点为 0.2 名患者/月。有公共资金支持的站点每月入组 0.4 名患者，而私人资金支持的站点每月入组率为 0.17 名患者。
作为一个协作组，PARITY 研究人员在整个试验过程中加快了招募速度，可能是通过增加活跃站点的数量。国际站点启动时间较长可能是由于药物试验的复杂监管法规所致。然而，国际站点应该被认为是必不可少的，因为它们一旦开始活动，每月招募的患者数量明显更多。缺乏研究支持人员可能导致启动时间延迟。本研究的结果将为选择哪些站点招募参加未来骨科肿瘤学和其他外科专业的合作临床试验提供指导。
ClinicalTrials.gov NCT01479283。于 2011 年 11 月 24 日前瞻性注册。
