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In this episode of the Real World Talk podcast, our host Drew Belli introduces Donna Rivera, the Associate Director for Pharmacoepidemiology, RWD & RWE at FDA Oncology Center of Excellence.
Donna is a pharmacist and pharmacoepidemiologist with over ten years of clinical pharmacy, data science, and research expertise across government, academia, and industry enterprise. She’s passionate about cultivating collaborations that facilitate real-world data (RWD) transformation into real-world evidence (RWE) in Oncology to meaningfully improve drug development and outcomes for patients.
Donna and Drew talk about the role that high-quality data plays in healthcare, especially amid the COVID outbreak. Donna explains, “Data is arguably one of the most valuable assets in combating the pandemic from textbook epidemiology which is cases and testing to understanding affected populations and evaluating the use of new therapies to now vaccine distribution.”
Real-world data drives smarter, evidence-based decisions. It goes beyond the data gathered during randomized controlled trials and has the power to unlock practical healthcare insights. Donna talks about how FDA leverages the real-world data, how COVID has impacted the cancer treatment landscape, and why it’s important to achieve diversity in clinical trials.
[00:39] Introduction— The host Drew Belli introduces Donna Rivera, the Associate Director for Pharmacoepidemiology at FDA Oncology Center of Excellence. Donna shares some of her key job responsibilities and goals.
[04:59] Putting the patient first— The mission of OCE is to achieve patient-centered regulatory decision-making through innovation and collaboration. Donna explains how they keep the patient at the center of everything they do. “We are patient-centered. We serve the people. And so the goal of approving safe and effective drugs, of conducting and supporting high quality, high impact research is to help others. It’s for the greater good.”
[07:45] The importance of high-quality data to make evidence-based decisions — Drew and Donna reflect on the key role that data plays in healthcare, especially facing the pandemic. “Data is arguably one of the most assets in combating the pandemic from textbook epidemiology which is cases and testing to understanding affected populations and evaluating the use of new therapies to now vaccine distribution.”
[08:36] Leveraging real-world data in COVID research — Due to the need for rapid knowledge facing the pandemic, real-world data played a major part in guiding healthcare policy decision-making. Donna adds that randomized controlled trials are still the gold standard, but real-world data can play a complementary role in therapeutic development.
[11:57] The ongoing progress of establishing methodologies and definitions for the real-world data — Donna talks about the progress the scientific community is yet to make, relying on collective collaboration and best data practices. “I think a critical unmet need is a more broad consensus on ways to assess real-world data. Quality and fitness for purpose across various regulatory objectives from use data to safety, to efficacy.”
[19:19] How to use real-world data most effectively? — Donna says the continuum of potential uses for real-world data is vast. From complimenting our understanding of drug safety and effectiveness to a more methodological context, real-world data is an emerging area of interest in the healthcare industry.
[27:08] The role of real-world evidence in precision oncology and innovative trial design — Donna talks about the evolving role that real-world data plays in precision oncology. She adds, “I think even where real-world data is not necessary as a comparator, real-world data can assist in precision medicine with contextualizing data from randomized controlled trials.”
[31:58] Real-world data is a small piece of a much broader effort in achieving diversity in clinical trial populations — Donna believes that the topic of diversity and representativeness in trials is extremely important. According to her, it is possible for data to advance this conversation and improve the issue, but it’s still only a part of the conversation.
[35:53] The impact of COVID on healthcare — COVID has been a great accelerator of cancer research. Donna says that the focus is on learning important lessons in real-world data for patients with COVID and cancer regulators. “COVID has really galvanized the scientific and clinical care communities, revealing incredible dedication and extraordinary efforts within both the scientific and therapeutic development community.”
[39:27] Project COVIDity and the future of clinical trials after COVID — Donna shares the objectives behind project COVIDity. “The objective of this project is really developing a longitudinal understanding of the impact of COVID-19. On patients with cancer, post-infection, including the impact of infection on treatment initiation or delays, regimen, selection, and therapeutic utilization patterns as well as potential adverse sequelae and outcomes.”