Q: What have you learned so far from your rapid work to develop COVID-19 interventions?
A: We’re learning a lot of digital lessons in our ongoing non-COVID trials. We had to completely reimagine many studies due to COVID-19, so we shifted to telemedicine, shipped drugs to people's homes or pharmacies, and created new models for safety monitoring and information gathering. Looking back, we’ve learned that much of clinical trials can be done remotely.
This is beneficial for a large segment of the population, and is one of the positive changes driven by COVID-19. For example, people who experience economic hardship may find it burdensome to participate in clinical studies. But if they’re able to do it from home, on their own schedules, we’ll likely see improved diversity and inclusion in clinical research. Across our research programs—and as we consider expanding remdesivir’s indication into the outpatient setting—we’re thinking creatively about how we can make trials informative while offering study options that encourage participation.
Q: How can cross-industry partnerships help more effectively harness the power of RWE to address COVID-19?
A: In addition to leveraging existing partnerships with hospitals and other groups, we’ve also entered new collaborations to increase our understanding of COVID-19. One partnership that has been particularly helpful in this effort is the Reagan-Udall Foundation for the FDA and Friends of Cancer Research’s COVID-19 Evidence Accelerator.
This partnership has moved the needle for us in terms of understanding how to identify COVID-19 patients within RWD, use those data as effectively as possible, and sync with regulators and industry leaders in real time. In the past, we’ve had to do this work in a stepwise fashion—a time consuming process, which, in turn, impacted development decisions. We had to choose whether we would take the extra time to forge ahead with RWE—something considered untraditional in the virology space—or continue with the traditional, accepted methods. Through our work with the COVID-19 Evidence Accelerator, we’ve been able to do both, because all of the key stakeholders are at the table together.
In addition, if we’re able to work as an industry to validate real-world endpoints, we can help make the data useful from a regulatory standpoint. This will also align well with the mandate for value demonstration post-approval. If we can match approvable endpoints with meaningful RWD—for example, the complex constellation of endpoints required for rheumatologic diseases, which are collected through X-rays and other tests—we can more seamlessly connect which drugs get approved with what happens in the real world. This will be a win for biopharma, regulators, and patients.
This piece was originally published on Aetion's blog, the Evidence Hub.