Considering the already high costs involved in conducting clinical trials, the complex regulatory environment, expectations of investors and other stakeholders, the lack of early warning systems of potential clinical trail failures is surprising. In this article we discuss possible reasons for failure and how to better manage these trials.
The concepts around decentralized or virtual clinical trials have been extensively developed over the last years. Especially with the start of the COVID-19 pandemic, companies have been faced with new challenges: to keep the patients in their ongoing clinical trials or even to recruit new patients for the studies. Regulatory authorities adjusted quickly to support new approaches to clinical trials and the concepts of decentralized clinical trials experienced a large upswing.