Malfettone Andrea, Di Cosimo Serena, Pérez-García José Manuel, García Alicia, Sampayo-Cordero Miguel, Mina Leonardo, Herrero Carolina, Llombart-Cussac Antonio, Cortés Javier
Medica Scientia Innovation Research (MEDSIR), Ridgewood, NJ, USA.
Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain.
NPJ Breast Cancer. 2021 Apr 8;7(1):39. doi: 10.1038/s41523-021-00249-1.
In the global health emergency caused by the COVID-19, clinical trial management has proven to be critical for the pharmaceutical industry, sponsors, and healthcare professionals. Our experience as a sponsor managing interventional oncology clinical studies has provided us with some data and insights. Though limited by sample size, our data emphasize the importance of quickly adopting measures that first prioritize patient safety and data validity, then consider contingency measures such as telemedicine, virtual medical review, and remote monitoring. Successful adaptations of healthcare and patient management in response to COVID-19 have been fundamental to ensuring continuing clinical cancer research.
在由新冠疫情引发的全球卫生紧急状况下，临床试验管理已被证明对制药行业、申办方和医疗保健专业人员至关重要。我们作为申办方管理介入肿瘤学临床研究的经验为我们提供了一些数据和见解。尽管受样本量限制，但我们的数据强调了迅速采取措施的重要性，这些措施首先要优先考虑患者安全和数据有效性，然后再考虑诸如远程医疗、虚拟医学审查和远程监测等应急措施。成功调整医疗保健和患者管理以应对新冠疫情，对于确保癌症临床研究的持续开展至关重要。
