Decentralized Trials In Japan: How COVID-19 Has Accelerated A Previously Underutilized Practice

Clinical drug development is a costly process that takes 10 years to complete, on average. The cost of developing a new drug is about 2.6 billion USD with over 65% of that being dedicated to the clinical testing phase.

Decentralized Trials, also referred to as Virtual Clinical Trials, is a method that leverages modern digital technology for the benefit of the patients and overall progression of drug development.

The influence of COVID-19 is felt in every industry. For the Pharmaceutical industry, clinical trials came to a standstill worldwide. The previously practiced approach of having patients travel to clinical sites for their trials have always been a burden for patients. Prior to the first wave of COVID-19, the implementation of virtual clinical trials was always the subject of vigorous discussion following the 2018 “Guidelines for Proper Implementation of Online Consultations”. In March 2020, the FDA announced new guidance encouraging clinical trials to be decentralized¹in order to prevent a research  bottleneck while getting drugs to market.