Bikou Alexia Georgia, Deligianni Elena, Dermiki-Gkana Foteini, Liappas Nikolaos, Teriús-Padrón José Gabriel, Beltrán Jaunsarás Maria Eugenia, Cabrera-Umpiérrez Maria Fernanda, Kontogiorgis Christos
Department of Medicine, Democritus University of Thrace, Alexandroupolis, Greece.
Life Supporting Technologies (LifeSTech), Superior Technical School of Telecommunication Engineers, Universidad Politécnica de Madrid (UPM), Madrid, Spain.
J Med Internet Res. 2024 Dec 18;26:e60504. doi: 10.2196/60504.
Pharmaceutical product development relies on thorough and costly clinical trials. Participant recruitment and monitoring can be challenging. The incorporation of cutting-edge technologies such as blockchain and artificial intelligence has revolutionized clinical research (particularly in the recruitment stage), enhanced secure data storage and analysis, and facilitated participant monitoring while protecting their personal information.
This study aims to investigate the use of novel digital platforms and their features, such as e-recruitment, e-consent, and matching, aiming to optimize and expedite clinical research.
A review with a systematic approach was conducted encompassing literature from January 2000 to October 2024. The MEDLINE, ScienceDirect, Scopus, and Google Scholar databases were examined thoroughly using a customized search string. Inclusion criteria focused on digital platforms involving clinical trial recruitment phases that were in English and had international presence, scientific validation, regulatory approval, and no geographic limitations. Literature reviews and unvalidated digital platforms were excluded. The selected studies underwent meticulous screening by the research team, ensuring a thorough analysis of novel digital platforms and their use and features for clinical trials.
A total of 24 digital platforms were identified that supported clinical trial recruitment phases. In general, most of them (n=22, 80%) are headquartered and operating in the United States, providing a range of functionalities including electronic consent (n=14, 60% of the platforms), participant matching, and monitoring of patients' health status. These supplementary features enhance the overall effectiveness of the platforms in facilitating the recruitment process for clinical trials. The analysis and digital platform findings refer to a specific time frame when the investigation took place, and a notable surge was observed in the adoption of these novel digital tools, particularly following the COVID-19 outbreak.
This study underscores the vital role of the identified digital platforms in clinical trials, aiding in recruitment, enhancing patient engagement, accelerating procedures, and personalizing vital sign monitoring. Despite their impact, challenges in accessibility, compatibility, and transparency require careful consideration. Addressing these challenges is crucial for optimizing digital tool integration into clinical research, allowing researchers to harness the benefits while managing the associated risks effectively.
药品研发依赖于全面且成本高昂的临床试验。参与者招募和监测可能具有挑战性。区块链和人工智能等前沿技术的融入彻底改变了临床研究（尤其是在招募阶段），增强了数据的安全存储和分析，并在保护参与者个人信息的同时便于对参与者进行监测。
本研究旨在调查新型数字平台及其功能的使用情况，如电子招募、电子知情同意和匹配，以优化和加快临床研究。
采用系统方法进行综述，涵盖2000年1月至2024年10月的文献。使用定制的搜索字符串对MEDLINE、ScienceDirect、Scopus和谷歌学术数据库进行了全面检索。纳入标准侧重于涉及临床试验招募阶段的数字平台，这些平台需为英文且具有国际影响力、经过科学验证、获得监管批准且无地域限制。排除文献综述和未经验证的数字平台。研究团队对所选研究进行了细致筛选，确保对新型数字平台及其在临床试验中的使用和功能进行全面分析。
共识别出24个支持临床试验招募阶段的数字平台。总体而言，其中大多数（n = 22，80%）的总部设在美国并在美国运营，提供一系列功能，包括电子知情同意（n = 14，占平台的60%）、参与者匹配以及对患者健康状况的监测。这些补充功能提高了平台在促进临床试验招募过程中的整体有效性。分析和数字平台的研究结果涉及调查进行时的特定时间段，并且观察到这些新型数字工具的采用显著增加，尤其是在新冠疫情爆发之后。
本研究强调了所识别的数字平台在临床试验中的重要作用，有助于招募、增强患者参与度、加快流程并实现生命体征监测的个性化。尽管它们具有影响力，但在可及性、兼容性和透明度方面的挑战仍需仔细考虑。应对这些挑战对于优化数字工具融入临床研究至关重要，使研究人员能够在有效管理相关风险的同时利用其优势。
