Bright Kristin, Mills Anneliese, Bradford John-Peter, Stewart David J
Department of Anthropology, Middlebury College, Middlebury, VT, United States.
Department of Anthropology, University of Toronto, Toronto, ON, Canada.
Front Health Serv. 2023 Feb 27;3:1015621. doi: 10.3389/frhs.2023.1015621. eCollection 2023.
Predictive oncology, germline technologies, and adaptive seamless trials are promising advances in the treatment of lethal cancers. Yet, access to these therapies is stymied by costly research, regulatory barriers, and structural inequalities worsened by the COVID-19 pandemic.
To address the need for a comprehensive strategy for rapid and more equitable access to breakthrough therapies for lethal cancers, we conducted a modified multi-round Delphi study with 70 experts in oncology, clinical trials, legal and regulatory processes, patient advocacy, ethics, drug development, and health policy in Canada, Europe, and the US. Semi-structured ethnographic interviews ( = 33) were used to identify issues and solutions that participants subsequently evaluated in a survey ( = 47). Survey and interview data were co-analyzed to refine topics for an in-person roundtable where recommendations for system change were deliberated and drafted by 26 participants.
Participants emphasized major issues in patient access to novel therapeutics including burdens of time, cost, and transportation required to complete eligibility requirements or to participate in trials. Only 12% of respondents reported satisfaction with current research systems, with "patient access to trials" and "delays in study approval" the topmost concerns.
Experts agree that an equity-centered precision oncology communication model should be developed to improve access to adaptive seamless trials, eligibility reforms, and just-in-time trial activation. International advocacy groups are a key mobilizer of patient trust and should be involved at every stage of research and therapy approval. Our results also show that governments can promote better and faster access to life-saving therapeutics by engaging researchers and payors in an ecosystem approach that responds to the unique clinical, structural, temporal, and risk-benefit situations that patients with life-threatening cancers confront.
预测性肿瘤学、生殖系技术和适应性无缝试验是治疗致命癌症的有前景的进展。然而，这些疗法的可及性受到成本高昂的研究、监管障碍以及因新冠疫情而加剧的结构性不平等的阻碍。
为满足制定一项全面战略以实现快速且更公平地获取致命癌症突破性疗法的需求，我们对加拿大、欧洲和美国的70位肿瘤学、临床试验、法律和监管程序、患者权益倡导、伦理学、药物研发及卫生政策方面的专家开展了一项经过改进的多轮德尔菲研究。采用半结构化人种志访谈（n = 33）来确定问题及解决方案，参与者随后在一项调查（n = 47）中对这些问题及解决方案进行评估。对调查和访谈数据进行共同分析，以完善面对面圆桌会议的主题，26名参与者在该会议上审议并起草了系统变革建议。
参与者强调了患者获取新型疗法方面的主要问题，包括完成资格要求或参与试验所需的时间、成本和交通负担。只有12%的受访者对当前的研究系统表示满意，“患者参与试验的机会”和“研究批准延迟”是最主要的担忧。
专家们一致认为，应建立一种以公平为中心的精准肿瘤学沟通模式，以改善适应性无缝试验入选资格改革以及及时启动试验的可及性。国际倡导团体是患者信任的关键推动者，应参与研究和治疗批准的每个阶段。我们的结果还表明，政府可以通过采用生态系统方法让研究人员和支付方参与进来，以应对危及生命的癌症患者所面临的独特临床、结构、时间以及风险效益情况，从而促进更快更好地获取挽救生命的疗法。
