Abstrakt

Navigating post-COVID-19: How can clinical trials optimize efficiency and effectiveness during pandemics?

Patrick Mutunga Mwanza*

Worldwide, clinical research teams are confronting issues of scale as they seek to develop novel therapies. Emerging complexities such as COVID-19 pandemic, limited resources, technology systems, multiple stakeholders and vendors are some of the recent examples that have challenged clinical trial management. To stay ahead of potential issues in a real-time, sponsors and CROs have opted to remain vigilant on high-value activities, embrace adaptive systems and workflows, as well as embracing the revised ICH E8 (R1) addendum. Attempts to optimize and streamline clinical operations workflows currently remains elusive. Leveraging strategic designs into clinical trial execution has been suggested as a missing link especially during the current pandemic. Strategic design is a procedure used to unpack game-changing insights into clear, concise, and complete actions for execution. It demystifies and illuminates on: the what, where, who, when, why, and how of operations. Due to the Coronavirus disease 2019 (COVID-19) pandemic, clinical trial landscape has evolved rapidly in response to challenges such as quarantines, site closures, travel limitations, study supply chain interruptions, and front line site personnel exposure risk. These challenges may lead to deficiencies in meeting protocolspecified procedures such as investigational product (IP) administration, compliance to protocolmandated visits, and adherence to laboratory or diagnostic testing. These add a background noise to an environment of growing complexity hence the need for a range of innovative approaches such as streamlining trial designs, virtual visits, patient-centric enrollment, patient’s insights, patients-facing techs, analytics-driven feasibility, digitalization of clinical trials, among others. These approaches are designed to quickly evaluate promising therapeutics without rebuilding research infrastructure. However, in an environment with imprecise predictability, managing clinical trials of any size and complexity requires strategic planning and robust execution. The need for strategic design is more pressing now than ever to ensure extensive savings in time and cost.