Regulatory agilities applied to clinical trials
Implementing agilities related to clinical trials was key to protect participant safety and ensure the continuity of clinical research, enabling safe and effective COVID-19 and non-COVID-19 related pharmaceutical products to be developed and approved.
Extraordinary measures have been applied by National Regulatory Authorities (NRAs) and the pharmaceutical industry to face the challenges brought by the COVID-19 pandemic emergency. A variety of agilities in clinical trials processes have been key to allow rapid research and development of safe and effective COVID-19 and non COVID-19 related medicines and vaccines.
This policy briefing summarizes trends in reported experiences (from primary and secondary research) in the use of regulatory agilities in clinical trials observed since the start of the pandemic, reported challenges to their implementation and forward looking recommendations, whether to prepare for the next pandemic or to modernize standard normative processes to accelerate patient access to safe and effective medicines.