Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Switzerland.
Georgia Cancer Center, Augusta, USA.
ESMO Open. 2022 Feb;7(1):100339. doi: 10.1016/j.esmoop.2021.100339. Epub 2021 Nov 23.
The coronavirus disease-19 (COVID-19) pandemic promises to have lasting impacts on cancer clinical trials that could lead to faster patient access to new treatments. In this article, an international panel of oncology experts discusses the lasting impacts of the pandemic on oncology clinical trials and proposes solutions for clinical trial stakeholders, with the support of recent data on worldwide clinical trials collected by IQVIA. These lasting impacts and proposed solutions encompass three topic areas. Firstly, acceleration and implementation of new operational approaches to oncology trials with patient-centric, fully decentralized virtual approaches that include remote assessments via telemedicine and remote devices. Geographical differences in the uptake of remote technology, including telemedicine, are discussed in the article, focusing on the impact of the local adoption of new operational approaches. Secondly, innovative clinical trials. The pandemic has highlighted the need for new trial designs that accelerate research and limit risks and burden for patients while driving optimization of clinical trial objectives and endpoints, while testing is being minimized. Areas of considerations for clinical trial stakeholders are discussed in detail. In addition, the COVID-19 pandemic has exposed the underrepresentation of minority groups in clinical trials; the approach for oncology clinical trials to improve generalizability of efficacy and outcomes data is discussed. Thirdly, a new problem-focused collaborative framework between oncology trial stakeholders, including decision makers, to leverage and further accelerate the innovative approaches in clinical research developed during the COVID-19 pandemic. This could shorten timelines for patient access to new treatments by addressing the cultural and technological barriers to adopting new operational approaches and innovative clinical trials. The role of the different stakeholders is described, with the aim of making COVID-19 a catalyst for positive change in oncology clinical research and eventually in cancer care.
新型冠状病毒病-19（COVID-19）大流行有望对癌症临床试验产生持久影响，从而使患者更快地获得新的治疗方法。在本文中，一组国际肿瘤学专家讨论了大流行对肿瘤临床试验的持久影响，并在 IQVIA 收集的全球临床试验最近数据的支持下，为临床试验利益相关者提出了解决方案。这些持久影响和拟议的解决方案涵盖了三个主题领域。首先，通过以患者为中心的完全去中心化的虚拟方法加速并实施新的肿瘤试验运营方法，其中包括通过远程医疗和远程设备进行远程评估。文章讨论了远程技术（包括远程医疗）在地理上的采用差异，重点讨论了新运营方法在当地采用的影响。其次，创新临床试验。大流行凸显了需要新的试验设计，这些设计可以加快研究速度，降低患者的风险和负担，同时优化临床试验目标和终点，同时尽量减少测试。详细讨论了临床试验利益相关者的考虑领域。此外，COVID-19 大流行暴露了临床试验中少数群体代表性不足的问题；讨论了改善肿瘤临床试验普遍性和结果数据的方法。第三，在肿瘤试验利益相关者（包括决策者）之间建立一个以问题为导向的新合作框架，利用和进一步加速在 COVID-19 大流行期间开发的临床研究中的创新方法。通过解决采用新运营方法和创新临床试验的文化和技术障碍，可以缩短患者获得新治疗方法的时间线。描述了不同利益相关者的作用，旨在使 COVID-19 成为肿瘤临床研究乃至癌症护理积极变革的催化剂。
