Breast cancer survivor, clinical trial participant, and partner at Hunton Andrews Kurth LLP, Richmond, VA.
Memorial Sloan Kettering Cancer Center, New York, NY.
Am Soc Clin Oncol Educ Book. 2022 Apr;42:1-7. doi: 10.1200/EDBK_349671.
The COVID-19 pandemic presented many challenges to health care systems, including oncology clinical research programs. There were substantial negative effects on oncology clinical trial screening, enrollment, and study activities that forced institutions and regulatory bodies to develop innovative solutions to maintain robust and equitable participation in these trials. Digital pathology innovations at Memorial Sloan Kettering Cancer Center have streamlined the diagnostic life cycle for patients with cancer, and the seamless integration of digital pathology services with next-generation sequencing and other molecular pathology services have accelerated the time to diagnosis and receipt of molecular results. Timely access to these results, coupled with Memorial Sloan Kettering Cancer Center's knowledge engine OncoKB, enhances patient clinical trial coordination precisely and efficiently. At the Sarah Cannon Research Institute, centralized remote clinical trial matching and screening, virtual molecular tumor boards, and centralized molecular interpretation support services have empowered clinic staff to identify more efficiently potential participants in clinical research, despite the COVID-19 pandemic. In addition, the U.S. Food and Drug Administration Oncology Center of Excellence has been involved in several efforts to address challenges for patients with cancer during the COVID-19 pandemic, including writing guidance documents and participating in efforts to modernize clinical trials. The enclosed personal experience of a patient with cancer currently participating in an oncology clinical trial emphasizes the need for continued decreasing of barriers to study participation. Clinical trial advances that were accelerated by the pandemic will ultimately help patients with cancer and the greater oncology health care community.
新冠疫情给医疗保健系统带来了许多挑战，包括肿瘤临床研究项目。这对肿瘤临床试验的筛选、入组和研究活动产生了重大的负面影响，迫使机构和监管机构开发创新的解决方案，以维持这些试验的稳健和公平参与。纪念斯隆凯特琳癌症中心的数字病理学创新简化了癌症患者的诊断生命周期，数字病理学服务与下一代测序和其他分子病理学服务的无缝集成，加快了诊断和获得分子结果的时间。及时获得这些结果，并结合纪念斯隆凯特琳癌症中心的知识引擎 OncoKB，精确高效地增强了患者临床试验的协调。在 Sarah Cannon 研究所以及临床研究所，集中的远程临床试验匹配和筛选、虚拟分子肿瘤委员会，以及集中的分子解读支持服务，使临床工作人员能够更有效地识别出临床研究中的潜在参与者，尽管存在新冠疫情。此外，美国食品和药物管理局肿瘤卓越中心参与了几项努力，以解决癌症患者在新冠疫情期间面临的挑战，包括撰写指导文件和参与使临床试验现代化的努力。一位正在参与肿瘤学临床试验的癌症患者的个人经验强调了继续减少研究参与障碍的必要性。疫情加速的临床试验进展最终将帮助癌症患者和更广泛的肿瘤医疗保健社区。
