CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Rationale and Design of the Cancer Immunotherapy Evidence Living (CIEL) Library: A Continuously Updated Clinical Trial Database of Cancer Immunotherapies.
Rationale and Design of the Cancer Immunotherapy Evidence Living (CIEL) Library: A Continuously Updated Clinical Trial Database of Cancer Immunotherapies.
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CIEL-Library 通过提供一组带有精选试验特征和结果的临床试验集合,为动态证据综合基础设施提供了蓝图。该蓝图可应用于不同领域、专业和主题。构建临床试验数据库的主要挑战在于填充和维护精选及更新数据所需的时间和资源。CIEL-Library 项目突显了设计用于常规护理中的试验数据库的潜力及主要局限性。
癌症免疫疗法正在大量临床试验中进行测试。临床医生和研究人员难以跟上证据更新的步伐,而传统的系统评价和临床指南并不适合确保持续概览所有试验及其结果。为解决这一问题,我们设计了癌症免疫治疗证据动态(CIEL)图书馆。
我们纳入了针对癌症免疫疗法的计划中、进行中及已完成的干预性试验,不论试验设计如何(如随机化、盲法和对照类型)。我们系统检索了PubMed(用于已发表报告)和ClinicalTrials.gov(用于注册临床试验)。通过AI辅助软件ASReview筛选PubMed检索到的记录,并进行手动提取和整理。我们利用临床试验转化倡议数据库从ClinicalTrials.gov导入数据,该数据随后需要进一步整理。CIEL-Library以网络应用程序形式实现,并包含“匹配我的患者”功能,这是一个以患者为中心的临床决策支持系统,旨在根据四项患者特征(疾病分期、既往治疗、体能状态和地理位置)筛选计划中、进行中或已完成的试验。我们以一类癌症免疫疗法——TIL(肿瘤浸润淋巴细胞)转移——作为试点测试了我们的数据库。CIEL-Library为原型版本,目前无进一步开发计划。
We included planned, ongoing, and completed interventional trials of immunotherapies for cancer, regardless of trial design (e.g., randomization, blinding, and type of comparator). We systematically searched PubMed (for published reports) and ClinicalTrials.gov (for registered clinical trials). PubMed-retrieved records were screened using the AI-assisted software ASReview and manually extracted and curated. We imported data from ClinicalTrials.gov using the Clinical Trials Transformation Initiative database, which then requires further curation. The CIEL-Library was implemented as a web application. It also contained the "Match My Patient" feature, a patient-centered clinical decision support system, aiming to filter planned, ongoing, or completed trials based on four patient characteristics (disease staging, previous treatments, performance status, and location). We piloted our database with one type of cancer immunotherapy, the tumor-infiltrating lymphocytes (TIL) transfer. The CIEL-Library was a prototype and no further developments are planned.
The CIEL-Library offers a blueprint for a dynamic evidence synthesis infrastructure by providing a collection of clinical trials with curated trial characteristics and results. This blueprint may be applied across fields, specialties, and topics. The main challenges to making a database of clinical trials are the time and resources needed to populate it with curated and updated data. The CIEL-Library project highlights the potential and the main limitations of designing trial databases intended to be used in routine care.
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