After many years with the FDA, Laura Fernandes, PhD joined COTA to lead statistical and analytical operations. She has seen first-hand the need for real-world data and now speaks about the imperative work COTA has brought to the industry to advance patient care.
How RWD can fill in the gaps
Oftentimes, when I meet new people, I am asked what it’s like to work at the FDA. I tell them that it’s very demanding, high-stakes work having tangible impacts on public health, but simultaneously satisfying to know that I am contributing to better outcomes for cancer patients.
Cancer is a monster with many heads, and we must work together to fight this disease on all fronts. Working at the FDA gave me an unparalleled understanding of what it takes to bring to fruition one of the most important weapons in our arsenal: safe and effective therapies that target cancers from novel pathways. I consider myself very fortunate to have had the unique experience of seeing behind the curtain and directly participating in the approval process of multiple cancer therapies.
In recent years, it became very clear that we need better solutions for developing and executing clinical trials especially in rare patient populations. We often lack access to enough patients for well-designed comparative effectiveness trials, and those patients aren’t always diverse enough to inform how therapeutic agents will work in the general population.
These challenges create a lot of roadblocks for researchers and regulators but at the same time present opportunities for use of complementary data sources like real world data (RWD) in clinical trials. I know firsthand what the FDA looks for when reviewing a submission. I know how closely they scrutinize the data and how important it is to have clean, complete documentation about data and its provenance. In my current role at COTA, I have the opportunity to use RWD to efficiently demonstrate the safety and effectiveness of newer therapies over existing standard of care in a regulatory submission.
Spreading the word
In many ways, RWD is still in the nascent stages of showing what it can achieve. To advance, we will have to work together across the life science industry and create an ongoing dialogue about what RWD has to offer and how to unleash its full potential. This will include collaborating with life science companies, researchers, clinicians, patients, and the regulatory agencies to establish the rules of the road and design more effective and efficient clinical trials.
It’s in everybody’s interest to participate in this conversation, and I’m very excited to be a part of it. COTA has such a strong presence in the industry and a driven, energizing corporate culture full of people who are incredibly committed to finding better treatments for cancer patients. I’m looking forward to working with the wonderful folks at COTA, as well as our partners across the industry, to capitalize on the possibilities of RWD and make a real difference in the way we approach drug development and patient care.