23 Mar Preparing for the future of clinical trials

By Brad Hirsch, The Association of Clinical Research Professionals (ACRP)

Clinical trials are increasingly using longitudinal evidence generation, where repeated measurements are taken over time from the same set of patients. This is leading to changes in expectations of how research sites carry out trials.

“During the COVID-19 pandemic, we’ve seen therapies reaching the market more quickly in areas such as rare diseases, cancer, and Alzheimer’s disease,” says Brad Hirsch, MD, Head of Product & Implementation at Verily. “Regulatory decisions are increasingly relying on post-marketing data to monitor the safety and efficacy of these new products, boosting demand for longitudinal studies that combine real-world and clinical trial data.”

Hirsch highlights an example where Verily is collaborating with the Duke Clinical Research Institute and Pfizer on the HERO-TOGETHER study to collect real-world data on COVID-19 vaccines for up to two years in 20,000 U.S. healthcare workers, family members, and members of their communities. This includes data about side effects and hospitalizations. The study follows a global Phase III trial involving 44,000 participants at 155 sites; based on the results, the U.S. Food and Drug Administration granted an Emergency Use Authorization to the Pfizer-BioNTech COVID-19 vaccine to prevent COVID-19 in individuals aged 16 and older. Read more …