筛查日志：妇科肿瘤临床试验社区患者招募面临的挑战

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-09-29 DOI:10.1016/j.conctc.2024.101379

Rubina Ratnaparkhi , Gary C. Doolittle , Hope Krebill , Michelle Springer , Elizabeth Calhoun , Andrea Jewell , Dinesh Pal Mudaranthakam

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引用次数: 0

摘要

背景参与临床试验可以提高低容量社区中心妇科癌症患者的总生存率，并减少医疗保健方面的差异。本研究旨在评估一个集中管理但行政分散的电子筛查日志系统的有效性，该系统可在一个大的覆盖区内识别符合美国国家癌症研究所（NCI）指定的癌症中心开放临床试验条件的患者。方法回顾性审查了2014年至2021年期间从一个NCI指定的癌症中心覆盖区内的10个社区合作站点收集的电子筛查日志数据。评估的临床因素包括癌症部位、原发性与复发性疾病状态以及组织学。计算了识别效率（筛查出的患者中获得可用试验的比例）。结果在研究期间，10 个社区合作机构共为 492 名妇科癌症患者筛查了 7 项公开临床试验。其中包括 170 名（34.5%）卵巢癌患者、156 名（31.7%）子宫内膜癌患者和 119 名（24.2%）宫颈癌患者。超过 40% 的患者处于晚期，10.6% 的患者病情复发。只有 3 名患者被认定接受过相关的公开试验，但由于不符合试验资格标准，最终无一人入选。另外有 2-52 名患者被回顾性地发现有相关试验，尽管在电子筛选记录系统中并未被识别为相关试验。多达 14.4% 的患者缺少一个或多个最低数据元素，这阻碍了对临床试验可用性的全面评估。结论电子筛查日志系统可以提高NCI指定癌症中心的社区合作机构对妇科肿瘤临床试验的认识。然而，仅靠该系统不足以提高临床试验的注册率。提供足够的支持人员、持续记录临床因素、在相关时间间隔重新筛查患者，以及与中央研究人员协调，都可以提高该系统的效用。

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Screening log: Challenges in community patient recruitment for gynecologic oncology clinical trials

Background

Clinical trial participation can improve overall survival and mitigate healthcare disparities for gynecologic cancer patients in low-volume community centers. This study aimed to assess the effectiveness of a centrally regulated but administratively decentralized electronic screening log system to identify eligible patients across a large catchment area for a National Cancer Institute (NCI)-designated cancer center's open clinical trials.

Methods

Electronic screening log data collected between 2014 and 2021 from ten community partner sites in a single NCI-designated cancer center's catchment area were reviewed retrospectively. Clinical factors assessed included cancer site, primary versus recurrent disease status, and histology. Identification efficiency (the ratio of patients screened identified with an available trial) was calculated. Identification inefficiencies (failures to identify patients with a potentially relevant trial) were assessed, and etiologies were characterized.

Results

Across ten community partner sites, 492 gynecologic cancer patients were screened for seven open clinical trials during the study period. This included 170 (34.5 %) ovarian cancer patients, 156 (31.7 %) endometrial cancer patients, and 119 (24.2 %) cervical cancer patients. Over 40 % had advanced stage disease, and 10.6 % had recurrent disease. Only three patients were identified as having a relevant open trial; none ultimately enrolled due to not meeting trial eligibility criteria. An additional 2–52 patients were retrospectively found to have a relevant trial available despite not being identified as such within the electronic screening log system. Up to 14.4 % of patients had one or more missing minimum data elements that hindered full evaluation of clinical trial availability. Re-screening patients when new trials open may identify 12-15 additional patients per recurrent disease trial.

Conclusions

An electronic screening log system can increase awareness of gynecologic oncology clinical trials at a NCI-designated cancer center's community partner sites. However, it is inadequate as a single intervention to increase clinical trial enrollment. Providing adequate support staff, documenting clinical factors consistently, re-screening patients at relevant intervals, and coordinating with central study personnel may increase its utility.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.