Impact of COVID‒19 Pandemic on Clinical Pharmacology Trials in Japanese Subjects Conducted at Phase 1 Units in Japan or Overseas

The World Health Organization (WHO) declared COVID‒19 a pandemic in March 2020. The spread of COVID‒19 impacted the medical environment, and the clinical trial sites were likely to be affected. The International Consortium for Innovation and Quality in Pharmaceutical Development Clinical Pharmacology Leadership Group (IQ CPLG) Japan Sub-team conducted a survey to collect data from 13 IQ member companies on sponsor's experiences regarding the impact on timelines, study design and development strategy due to the COVID‒19 pandemic. This survey focused on clinical pharmacology trials in Japanese healthy subjects or patients conducted at phase 1 units planned or conducted during March to July 2020. The survey questions were designed to respond for each trial level and composed of 10 quantitative questions about the number of studies; characteristics of the study; the impact on the trial timeline; site selection; study design and one descriptive question for case studies. The survey results showed 1)most of the trials that enrolled Japanese subjects were conducted in Japan, 2)changes in study design were required,(e.g., prolonged admission period, COVID‒19 PCR test), 3)remote Source Data Verifications (SDVs) were introduced more widely and 4)limited sites were selected,(e.g., reduced capacity and available regions). Mild to moderate impacts on the study timeline prior to and during the trials indicated that it was necessary for companies to design the protocol and plan the operation to avoid anticipated risks which might have significantly impacted the study results. The impacts on program timeline and site selection were limited. Proactive planning is important in future pandemic situations. The present survey results and analyses provide useful insights, learnings and considerations that can be applied in future pandemics. The results of this survey were shared with the Japan Pharmaceuticals and Medical Devices Agency (PMDA).