Lesson Learned from Investigators of Clinical Trials to Identify Therapeutics for COVID-19: Qualitative Study

ABSTRACT

Background. Implementation of high-quality clinical trials especially early in the pandemic caused burden on clinical investigators given lack infrastructure, networks and systematic supports. To prepare for future pandemic, we investigated facilitator and obstacles that enable investigators to operate clinical trials for COIVD-19 in Japan. Methods. We conducted individual semistructured qualitative interviews to assess the process of how clinical trials for COVID-19 were planned and implemented at the early stage of pandemic. Clinical investigators were primarily selected through purposive sampling to ensure that participants involved in the clinical trials were well covered. Additional participants were identified using snowball sampling. Interviews were analyzed using qualitative descriptive method. Results. Through interviews, we identify factors that can impact on conduct clinical trials in infectious diseases field during health emergency in Japan (Figure). First, there are obstacles in rolling out clinical trials and this theme was further divided into two subthemes obstacles in system(such as lack of regulatory frameworks to support trials, lack of clinical trial networks/platform, and understanding and attitude of the public to clinical trial);and obstacles in clinical level (such as limited resource for nonacademic hospitals to implement clinical trials, and lack of trained experienced researchers and coordinators with regards to clinical trials). Secondary, a few factors that facilitate clinical trials exist. Not only governmental and organizational commitment but also presence of physicians and other healthcare professional interested in conducting trials are the key for facilitate clinical trials. Facilitators and obstacles to implement clinical trials for COVID-19 therapeutics Conclusion. In this qualitative study, clinical investigators in Japan who conducted clinical trials recognized both obstacles and facilitators. System level obstacles likely led to the obstacles in clinical level. Our finding emphasizes importance for health care policies to respond to such insight from front line clinical investigators to encourage systemwide efforts to facilitate and develop transparent clinical trials during future pandemic.