@MSDintheUK
OVID-19 pushed regulatory science and practices to new heights and brought stakeholders together in unprecedented ways to deliver safe and effective vaccines and medicines to patients in record time. While we cannot expect work to continue at this breakneck pace forever, some agilities proved themselves to be of significant value. To ensure that these regulatory lessons from the pandemic are not lost, it is critical to understand the impacts to and perspectives of stakeholders beyond regulators and industry. This article presents a brief summary of the discussions and conclusions of a multistakeholder workshop that allowed the understanding of diverse views on select agilities, which can inform if and how pandemic agilities are incorporated into routine agency practice.
The agilities implemented across the globe have been numerous and may be grouped into different categories. We will focus on five types of agilities that are closely associated with outstanding questions and discussion needs in the pharmaceutical field:
- Reliance and mutual recognition
- Convergence and harmonization
- Decentralized trials
- Data expectations for market entry
- Use of pre-market real-world evidence
Furthering Reliance and Mutual Recognition
Value of Convergence and Harmonization
Case for Decentralized Trials
Reassessing Data Expectations for Market Entry
- the overall features of uncertainty (e.g., the fact that it is found at some level in every decision) and how the state of science is constantly evolving;
- the level of evidence required, and how the benefit-risk calculus differs among patient populations and therefore demands different levels of evidence to enable speedy access; and
- the roles of regulators and public health agencies.
Engagement of the patient community is critical and currently missing. Using the patient only to improve communication approaches (versus ongoing meaningful engagement) will only increase the level of noise without improving trust in the process and product.
Advances in Use of Pre-Market Real-World Evidence (RWE)
Conclusion
While there is considerable consistency in stakeholder views, it is clear that nuances exist and context matters for every agility. Their use is rarely, if ever, “one size fits all,” and we must consider the trade-offs for each. These agilities can create both beneficial and costly consequences on different stakeholders. In addition, while the urgency of COVID-19 necessitated an all-encompassing single purpose, the use of agilities in routine practice will be situationally dependent. Agilities will need to be tailored to what is needed (and feasible), which is not necessarily what was needed in the pandemic. Further, making sure all stakeholder voices are included can elucidate the nuanced trade-offs and balance of benefit and burden (and to whom) inherent in all agilities.