Building a case for accelerated clinical development of drugs and vaccines - what are the driving forces?

Abstract

Background: The COVID-19 pandemic, among others, has shown the world that rapid drug and vaccine development and expedited clinical trials can be effective and safe. The overall benefit of accelerating clinical development would be faster public access to medicines. In this study, we explore key stakeholders' experiences and perceptions of drivers for the acceleration of clinical development.

Methods: We conducted semi-structured interviews with policy advisors and experts from key stakeholder groups involved in clinical development, identified via a power-interest stakeholder analysis. Thematic analysis was used to identify analytic themes.

Results: Twenty-five participants were interviewed representing pharmaceutical companies, the European Medicines Agency, national competent authorities in the EU, different research and clinical development organizations, including non-governmental organizations, and the World Health Organization. Drivers facilitating acceleration of clinical development could be grouped into three themes: alignment of stakeholders, innovative research design and processes, and financing. Some barriers of systematic acceleration were raised within these themes: European disharmony in trials practice, regulations and guidance; fragmentation of efforts; bureaucracy and the complexity of the Clinical Trials Information System (CTIS) submission process; and financial neglect for poverty-related diseases.

Conclusion: To sustainably accelerate clinical development, future policies should facilitate collaboration and communication between stakeholders and work to minimize technical and bureaucratic barriers.