How to plan for evidence generation in a time of uncertainty

Carolyn Magill
CEO, Aetion

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Much of my time lately has been dedicated to contemplating the magnitude of COVID-19’s impact. Writing from Brooklyn, as the CEO of a rapidly growing health care start-up, I’m also aware of the more acute disruptions to our daily lives.

Despite social distancing and self-quarantine, all in the health care industry remain united by a common goal—ensuring patients receive safe and effective treatments with minimal delay. We also recognize now more than ever that biopharma manufacturers, physicians, and payers are likely to turn to real-world evidence (RWE) as they ask critical questions regarding treatments and coverage. Our decisions have such high stakes that we need the level of scientific rigor and transparency RWE brings.

Top of mind are heightened concern on patient safety and provider capacity, and the associated delay or discontinuance of randomized controlled trials (RCTs). While not appropriate in all cases, RWE can help biopharma streamline treatment development to qualify new and repurposed treatments quickly and efficiently.

Whether evaluating treatments for COVID-19, or in adapting strategies for other assets, all health care decision makers can use RWE to speed time to insight on safety, effectiveness, and coverage questions.

Support development and deployment of COVID-19 treatments
There is a formidable push by global biopharma to develop treatments and vaccines to fight COVID-19. As more data about the virus become available, researchers will be able to measure COVID-related topics in real-world data (RWD), such as medication use and treatment outcomes. When facing a virus that impacts as broad of a population as COVID-19, RWD is an important tool for researchers. Running RWD analyses allows them to survey populations and identify the clinical questions they need to ask, and how quickly they must answer them. 

Supplement ongoing RCTs 
While the traditional RCT system is disrupted as, for example, hospital visits to gather clinical trial data are paused, manufacturers with products in development may consider alternative ways to demonstrate product safety and effectiveness to regulators. Here, they can use RWE to supplement regulatory submissions—for example, for meeting post-marketing requirements—and to otherwise address novel or complex questions. 

Forward progress in the face of uncertainty 
As we adapt to the new normal, clinicians and health insurance companies are particularly keen to rely on science and technology to deliver insights and solutions that can help slow, and eventually halt, the spread of this virus. In the meantime, we are investing in additional availability for thought partnership on best practices in RWE generation. Our experts are here to help with any questions you may have as you forge ahead in this critical work.

Please continue to tune into the Evidence Hub, as we share our scientists’ recommended readings on COVID-19, and our continued programming on all things RWE. 

Today and every day, we thank our biopharma partners for advancing the science that helps the world understand, manage, and treat disease. 

eBook: 2021 update

The Role of Real-World Evidence in FDA Approvals

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