Intermountain Health, Murray, UT.
American Society of Clinical Oncology, Alexandria VA.
J Clin Oncol. 2024 Nov 20;42(33):3986-3995. doi: 10.1200/JCO.24.00961. Epub 2024 Jul 30.
Strategies to bring clinical trials closer to patients gained momentum during the COVID-19 pandemic, enabling more participants to receive treatment and/or testing in their local communities. Incorporation of decentralized trial elements presents both opportunities and challenges, spanning regulatory, technical, and operational aspects. This ASCO research statement includes timely consensus-driven recommendations and a call for engagement of all research stakeholders. ASCO held multistakeholder meetings with leaders in oncology research and concluded that research-related regulatory and administrative requirements and burdens present critical barriers to decentralizing trials. One example is sponsor and contract research organization (CRO) use of US Food and Drug Administration (FDA)'s Statement of Investigator (Form 1572), which was found to exceed FDA's stated intent and used in conservative ways disproportionate to potential risks to participants and scientific integrity. As a result, research sites experience an avalanche of downstream administrative and regulatory activities that consume considerable resources. This statement recommends four key solutions to address such barriers and recalibrate regulatory and administrative expectations for decentralizing trials: (1) FDA should engage the research community in a public-private partnership to modernize standards and enable local access to trials; (2) sponsors and CROs should develop standards and protocols that accommodate flexible approaches, enable local participation, provide clarity around roles and requirements, and promote consistency; (3) research centers, networks, and sites should update policies and procedures to implement decentralized trial elements; and (4) research community should develop a streamlined, uniform mechanism to simplify regulatory data collection and documentation and use it consistently across trials. We can and must prioritize a concerted commitment to simplify and streamline regulatory requirements and practices to broaden access to and participation in cancer clinical trials.
在 COVID-19 大流行期间，将临床试验更贴近患者的策略得到了推进，使更多的参与者能够在当地社区接受治疗和/或测试。分散试验元素的纳入既带来了机遇，也带来了挑战，涵盖了监管、技术和运营方面。这份 ASCO 研究声明包括及时的共识驱动建议，并呼吁所有研究利益相关者参与。ASCO 与肿瘤学研究的领导者举行了多方利益相关者会议，并得出结论，与研究相关的监管和行政要求和负担是分散试验的关键障碍。一个例子是赞助商和合同研究组织（CRO）使用美国食品和药物管理局（FDA）的研究者声明（Form 1572），这被发现超出了 FDA 的既定意图，并以与参与者和科学完整性的潜在风险不成比例的保守方式使用。因此，研究机构经历了大量的后续行政和监管活动，消耗了相当多的资源。该声明建议了四个关键的解决方案来解决这些障碍，并重新调整分散试验的监管和行政期望：（1）FDA 应与研究界合作，建立公私合作伙伴关系，使标准现代化，并使当地能够参与试验；（2）赞助商和 CRO 应制定标准和协议，以适应灵活的方法，使当地能够参与，明确角色和要求，并促进一致性；（3）研究中心、网络和机构应更新政策和程序，以实施分散试验元素；（4）研究界应制定一个简化的、统一的机制，以简化监管数据的收集和记录，并在试验中一致使用。我们可以而且必须优先考虑做出一致的承诺，简化和精简监管要求和做法，以扩大癌症临床试验的参与和参与。
