Bruno Speder, VP of regulatory affairs & consultancy services, hVIVO, discusses how Human Challenge Trials (HCT) can be used in the framework of expedited review programs as part of drug and vaccine development.
Key insights:
- Human Challenge Trials can be used in a variety of ways, like dose-finding studies, in preparation for field trials, but the most common use is that HCTs are used as phase 2 proof-of-concept.
- HCTs are designed to provide early evidence about efficacy and determine if a drug is likely to be successful in later clinical trial phases.
- A number of RSV vaccines currently under development, including the J&J, Pfizer and Bavarian Nordic vaccines, received breakthrough and/or PRIME designation based on preliminary clinical evidence collected in a Human Challenge Trial.
- The efficacy data is collected in a well-defined model, without the 'noise' of a field trial. This allows the collection of 'crisp' data while being able to focus on the required clinical outcomes.
As evidenced by the Covid-19 pandemic, it is essential to bring new life-saving vaccines and antivirals to the market quickly. To support pharma and biotech companies in developing drugs and vaccines for serious diseases and unmet medical needs, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have set up different expedited review programs.