Xiang Jenny J, Roy Alicia, Summers Christine, Delvy Monica, O'Donovan Jessica, Christensen John, Dwy Christopher, Perry Lydia, Connery Donna, Rose Michal G, Sheehan Kelsey, Chao Herta H
Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
Department of Internal Medicine, VA Connecticut Healthcare System, West Haven, Connecticut.
JTO Clin Res Rep. 2022 Jun 8;3(7):100357. doi: 10.1016/j.jtocrr.2022.100357. eCollection 2022 Jul.
The oncology clinical trial recruitment process is time, labor, and resource intensive, and poor accrual rates are common. We describe the VA Connecticut Cancer Center experience of implementing a standardized, universal prescreening protocol and its impact on thoracic oncology research recruitment.
Research coordinators prescreened potentially eligible patients with confirmed or suspected cancer from multiple clinical sources and entered relevant patient and research study information into a centralized electronic database. The database provided real-time lists of potential studies for each patient. This enabled the research team to alert the patient's oncologist in advance of clinic visits and to prepare documents needed for enrollment. Clinicians could ensure sufficient time and attention in clinic to the informed consent process, therefore maximizing enrollment opportunities. Patients were also monitored on waitlists for future studies.
From March 2017 to December 2020, a total of 1518 patients with lung nodules and suspected or confirmed lung cancers were prescreened. Of these, 379 patients were enrolled to a study, 103 patients declined participation, and 639 were monitored for future studies. Our prescreening protocol identified all new patients with lung cancer who were ultimately added to the cancer registry. We found a substantial increase in study enrollment after prescreening implementation.
Universal prescreening was associated with improved patient enrollment to thoracic oncology studies. The protocol was integral in our VA becoming the top accruing VA site for National Cancer Institute's National Clinical Trials Network studies for 2019 to 2021.
肿瘤学临床试验的招募过程耗费时间、人力和资源,招募率低的情况很常见。我们描述了康涅狄格州退伍军人事务部癌症中心实施标准化通用预筛查方案的经验及其对胸部肿瘤学研究招募的影响。
研究协调员从多个临床来源对确诊或疑似癌症的潜在合格患者进行预筛查,并将相关患者和研究信息录入集中式电子数据库。该数据库为每位患者提供潜在研究的实时列表。这使研究团队能够在患者门诊就诊前提醒其肿瘤学家,并准备好入组所需的文件。临床医生可以确保在门诊有足够的时间和精力进行知情同意过程,从而最大限度地增加入组机会。还对列入候补名单等待未来研究的患者进行监测。
2017年3月至2020年12月,共对1518例有肺结节以及疑似或确诊肺癌的患者进行了预筛查。其中,379例患者入组研究,103例患者拒绝参与,639例患者被监测以待未来研究。我们的预筛查方案识别出了所有最终被纳入癌症登记的新发肺癌患者。我们发现实施预筛查后研究入组人数大幅增加。
通用预筛查与胸部肿瘤学研究中患者入组情况的改善相关。该方案对于我们退伍军人事务部在2019年至2021年成为美国国立癌症研究所国家临床试验网络研究中入组人数最多的退伍军人事务部站点起到了不可或缺的作用。