Near the end of April, the FDA reported 72 active clinical trials for potential coronavirus treatments and an additional 211 programs in the planning stages. While these essential controlled interventional studies will yield gold standard evidence, the severity of the pandemic demands more than ever before that we turn to Real World Data (RWD) for rapid generation of insights into the safety and efficacy of the many licensed therapies being repurposed for treatment of the disease.
Manufacturers and regulators are turning to RWD to gain insight on COVID-19 natural history, expose correlations between treatments and outcomes, and obtain urgently needed data on the safety of these repurposed treatments. FDA Principal Deputy Commissioner Amy Abernathy recently commented on this concept by saying, “Within the context of COVID-19, we’ve got this urgency to learn what we can as soon as we can, and that means that we need to be learning from the patients that are receiving care right now and trying to understand how do we apply that as quickly as possible”.
There are three crucial ingredients needed to produce these vital insights:
- Epidemiological and data science expertise for designing and executing regulatory grade research
- A technology platform to support rapid and dynamic outputs including validated analyses
- Access to vast and representative sources of RWD
UBC is engaged in an intense initiative to harness the power of RWD to support health care providers, regulators, and manufacturers as they seek to optimize the management of patients being treated for COVID-19. We have partnered with industry leaders across the healthcare data landscape to assemble a compelling array of pharmacy and medical claims, laboratory and EMR data to deliver fit for purpose evidence to the life science community through a robust platform of automated analytics and custom study-specific validated outputs.
To learn more about UBC’s capabilities and expertise in accelerating COVID-19 evidence generation, get in touch with us today.
To read about the essential role real world evidence will continue to play into the future.