Vanaken Hilde, Masand Shirley N
Janssen Clinical Innovation, Janssen Research & Development, Beerse, Belgium.
Accenture Life Sciences, Berwyn, PA, USA.
Ther Innov Regul Sci. 2019 Nov;53(6):724-735. doi: 10.1177/2168479019861924. Epub 2019 Jul 18.
While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials remains largely paper-based. Given the inefficiencies in the traditional process and the increasing complexity of clinical studies, the current approach at times may raise challenges with respect to quality, compliance, participant understanding, and trial retention. Electronic informed consent (eConsent) is an enabling clinical technology to potentially address these issues by using multimedia components to create an interactive participant experience and improve data quality.
The TransCelerate eConsent Initiative conducted a multifaceted engagement approach to better understand the perceptions, experiences, and concerns of impacted stakeholders, including participants, sites, ethics committees, and health authorities.
While all stakeholders were supportive of the use of multimedia components to deliver study information, several stakeholder-specific concerns were noted. Participant feedback, as collected through surveys (n = 3045) and an advisory board (n = 10), suggests that some participants may have data privacy concerns and a diversity of preferences for multimedia presentation. Site interviews (n = 9) suggest concerns related to additional operational activities and potential for technology failure. Health authorities' feedback, through nonbinding meetings, was geographically varied; ethics committee feedback, through interviews, suggests concern over impact on operational process changes.
While the appetite for eConsent is increasing, involved stakeholders and industry must continue to raise awareness, communicate, and collaborate to develop appropriate technological capabilities, regulatory pathways, and operational processes to clear the path for mainstream use of eConsent.
虽然向数字技术的转变在多个行业中普遍存在，但临床试验的知情同意过程在很大程度上仍基于纸质。鉴于传统过程的低效以及临床研究日益复杂，当前方法有时可能在质量、合规性、参与者理解和试验保留方面带来挑战。电子知情同意（eConsent）是一种临床技术，通过使用多媒体组件来创造交互式参与者体验并提高数据质量，有可能解决这些问题。
跨加速电子知情同意倡议采取了多方面的参与方式，以更好地了解受影响的利益相关者（包括参与者、研究点、伦理委员会和卫生当局）的看法、经验和担忧。
虽然所有利益相关者都支持使用多媒体组件来提供研究信息，但也注意到了一些特定于利益相关者的担忧。通过调查（n = 3045）和咨询委员会（n = 10）收集的参与者反馈表明，一些参与者可能存在数据隐私担忧以及对多媒体呈现的多种偏好。研究点访谈（n = 9）表明存在与额外操作活动和技术故障可能性相关的担忧。通过非约束性会议获得的卫生当局反馈在地域上存在差异；通过访谈获得的伦理委员会反馈表明担心对操作流程变化的影响。
虽然对电子知情同意的兴趣在增加，但相关利益相关者和行业必须继续提高认识、进行沟通和开展合作，以开发适当的技术能力、监管途径和操作流程，为电子知情同意的主流应用扫清道路。
