The approval of a safe and effective vaccine for COVID-19, only less than a year after the SARS-CoV-2 outbreak, is a scientific marvel. Vaccine development is in fact usually a slow and resource-intensive process that can take over ten years.  

This could not have happened without an extraordinary degree of collaboration between industry, regional and national regulatory authorities (NRAs), leading to probably one of the most streamlined processes to managing speed in innovation, efficacy and safety. Swift action was imperative, resulting in the adoption of several agilities to the design, approval, and conduct of clinical trials.  

Between 2021 and 2022, IFPMA assessed regulatory agilities used during the pandemic and focussed on identifying learnings to improve both pandemic preparedness and standard regulatory processes. IFPMA reviewed 36 international publications and surveys and conducted interviews with four participants from member associations in Africa, Asia, Latin America and the USA. As a result, we published a manuscript , policy briefings and recommendations for three common areas where agilities were applied: regulatory processes, quality and supply, and clinical trials.

Virtualization of working practices  

To speed up processes, reduce the risk of disease transmission, and allow clinical trials to continue, working practices were increasingly virtualized with the use of telemedicine, remote informed consent, e-documents and e-signatures.   

The design of clinical trials changed towards increased levels of decentralization, enabled by digital tools. Decentralized clinical trials, allowing for remote monitoring of patients and facilitating recruitment, helped to ensure study continuity and reduce the need for patients to travel to trial sites. 

Agilities in the execution, approval and amendments of clinical trials 

Travel restrictions necessitated agilities in the design and execution of clinical trials. For example, the requirement to inform NRAs of justified protocol deviations was lifted, and alternative means of drug delivery were permitted. 

In order to speed up clinical research, NRAs also adopted risk-based approaches to decision-making, like prioritizing the review and authorization of certain studies.  

How can regulatory agilities in clinical trials enhance future development of medicinal products? 

The COVID-19 pandemic has represented a unique challenge for the biopharmaceutical industry and NRAs. There is much to learn from the agilities that optimized clinical research during this difficult time. These learnings will not only allow us to better prepare for the next pandemic but can also help us enhance day-to-day clinical research.  

When the next pandemic arises, greater harmonization and alignment of regulatory requirements at the global level would help to speed up the implementation of clinical trials. Burdensome regulatory requirements were in fact sometimes perceived as delaying research during the pandemic. 

Alternative design of clinical trials and methods should be leveraged as much as possible to advance clinical research and lower barriers to participation to studies. Solutions, such as direct to patient delivery and use of alternative trial/lab sites, could be considered.  

To enhance standard clinical research, digital tools can be leveraged and a move towards more decentralization of clinical trials should be encouraged. Hybrid clinical trials can be a flexible alternative to fully decentralized clinical trials.   

Finally, the pandemic had a disproportionate toll on certain populations and minorities, highlighting the need to keep improving diversity and inclusion of under-represented populations in clinical trials at all times. Participation in clinical trials should be made easier for all and real-world evidence (RWE) can be leveraged to enhance information on diverse populations. Diversity and inclusion in clinical trials can help ensure more safety for all, foster public confidence and medicines uptake. 

Author

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  Sarah Adam Associate Director, Regulatory Affairs s.adam@ifpma.org