J Natl Cancer Inst. 2019 Sep 1;111(9):882-886. doi: 10.1093/jnci/djz076.
The problem of insufficient recruitment to clinical oncology trials is well known. Some stakeholders view mobile apps as a solution with the potential to make recruitment more efficient, lower trial costs, support patient-centeredness, and accelerate treatment advances. Recruitment and trial-finding apps seek to disrupt the traditional approach to recruitment in several ways, including aggregating information about ongoing trials and presenting it in a user-friendly format, curating information to tailor search results to prospective participants' interests, facilitating direct contact between prospective participants and trial sites, and, in at least one case, analyzing individuals' tumor samples and medical records to provide tailored recommendations both for approved treatments and clinical trials. Although recruitment and trial-finding apps respond to a real need, they raise ethical concerns. Here, we outline six domains of ethical concern: review of recruitment materials, privacy and confidentiality, constrained choice and conflicts of interest, therapeutic misbranding, payment for accessing research-related information, and disruptions to care and research. We offer several suggestions and encourage additional dialogue to improve the ethical acceptability of these apps because, as third parties increasingly promise to revolutionize clinical trial recruitment by connecting patients and investigators via recruitment and trial-finding apps, we need some rules of the road.
临床肿瘤学试验招募不足的问题众所周知。一些利益相关者认为移动应用程序是一种解决方案,具有提高招募效率、降低试验成本、支持以患者为中心以及加速治疗进展的潜力。招募和试验查找应用程序试图以多种方式打破传统的招募方法,包括汇总有关正在进行的试验的信息,并以用户友好的格式呈现,精心策划信息,根据潜在参与者的兴趣调整搜索结果,促进潜在参与者与试验地点之间的直接联系,并且至少在一种情况下,分析个人的肿瘤样本和医疗记录,为已批准的治疗方法和临床试验提供个性化建议。尽管招募和试验查找应用程序满足了实际需求,但它们也引发了伦理问题。在这里,我们概述了六个伦理关注领域:招募材料的审查、隐私和保密性、有限的选择和利益冲突、治疗错误宣传、获取与研究相关信息的报酬以及对护理和研究的干扰。我们提出了一些建议,并鼓励开展更多对话,以提高这些应用程序的伦理可接受性,因为随着第三方越来越承诺通过招募和试验查找应用程序将患者和研究人员联系起来,彻底改变临床试验招募,我们需要一些规则。