2021 年 52 巻 3 号 p. 63-66
The impact of COVID‒19 on our society is significant. To continue to offer new treatment options to society during and after the pandemic, experiences and ideas gained during this period should be utilized to transform drug development. Collaboration within the industry and with health authorities across the world is required, and now is the time to start the dialogue. To promote transformation, deploying methodologies based on high ethical standards and scientific rigor, prioritizing the safety of study participants, and securing transparency and the quality of deliverables are essential. In addition, broad acceptance of patient and public involvement is needed to promote understanding of drug development and to enable proactive participation of patients and family members. Utilization of digital tools and improving their reliability, the application of model informed drug development and real world data, improvement of regulatory procedures, continuous regulatory harmonization, and collaboration among companies and health authorities are required to continue to deliver breakthroughs that have a positive impact on society.
