With Robert F. Kennedy Jr. now at the helm of the Department of Health and Human Services (HHS), his recent speech to agency staff marked the beginning of what could be a seismic shift in U.S. healthcare policy. Among his key initiatives: launching investigations into whether antidepressants and the childhood vaccine schedule are contributing to chronic diseases.
We talked with Jeffrey Brown, PhD, Chief Scientific Officer at TriNetX, to unpack what these investigations could mean for pharmaceutical companies, regulatory science, and public health—and how TriNetX is positioned to help navigate the road ahead.
Q: If investigations into childhood vaccines move forward, what can pharmaceutical companies expect and how should they prepare?
Jeffrey Brown: Beyond the specific examples, we’re likely to see a generally heightened focus on the value of medical products, especially in terms of safety and effectiveness. For vaccines in particular, the risk-benefit ratio becomes critical. Since vaccines are administered to healthy individuals, often children, the tolerance for risk is appropriately very low. As a result, I expect pre-marketing clinical trials to grow in size, include longer safety follow-ups, and require more robust methods to account for multi-vaccine exposures.
Pharma companies should anticipate more comprehensive post-marketing commitments as well, especially for pediatric vaccines. These may include long-term safety studies and increased comparative effectiveness evaluations. To prepare, companies need to be proactive about generating strong evidence early, not just for approval but for real-world performance.
“When you’re vaccinating children with multiple vaccines at once, it’s difficult to disentangle effects and determine outcome attribution. It’s not about just asking whether vaccines are safe, it’s also about making sure the risk-benefit ratio is appropriate, and that requires rigorous, long-term, and methodologically sound scientific inquiry.”
Q: How can real-world data (RWD) and real-world evidence (RWE) support these investigations?
Jeffrey Brown: RWD and RWE are essential for contextualizing safety signals during clinical development and for confirming effectiveness in real-world use. For example, during a trial, if a few adverse events are observed, RWD can help determine whether those events are occurring at background rates in the general population, which refer to the normal frequency or prevalence of such events outside of a clinical trial setting. That context might help sponsors avoid costly, long-term post-marketing studies.
With high-quality RWD, you’re not only improving regulatory responsiveness, but also contributing to public health by providing rapid information on the performance of products in the real-world setting. That said, the strength of RWD and RWE depends on data quality, methodological rigor, and scientific credibility. This is where TriNetX stands out.
Q: What makes TriNetX uniquely positioned to support pharma during these investigations?
Jeffrey Brown: TriNetX is built to deliver real-time insights. Our data are updated continuously, unlike traditional claims databases that might be 6–12 months behind. That’s crucial when you’re trying to track safety events or understand usage trends early in a product’s lifecycle.
But we’re not just a data company—we’re a research partner. We focus on strong science, providing study design, analytics, and scientific support. We have deep expertise in conducting studies, particularly regulatory-grade studies used for decision-making.
Our scientific team includes experienced epidemiologists, data scientists, health services researchers, and regulatory strategists. These experts have hundreds of publications to their name, have experience leading large initiatives like the U.S. Food and Drug Administration’s (FDA’s) Sentinel Initiative and PCORnet®, and have served as Principal Investigators on numerous National Institutes of Health (NIH), FDA, and sponsor-funded RWD studies.
We also create unique data resources when existing data fall short in helping to answer a particular research question. Whether it’s linking to patient-reported outcomes or enhancing data streams through our health system partnerships, we ensure that sponsors have access to the most robust, fit-for-purpose data and evidence available.
Q: Given the potential for new regulatory landscapes, how should pharma adapt and how can TriNetX help them follow RWD and RWE guidance and stay competitive?
Jeffrey Brown: Sponsors need to think about compliance with guidance not just as a requirement, but as a strategic asset. The FDA and other global regulators are increasingly open to using RWE, but they expect high-quality submissions. That means using trusted data, established methodologies, and having a strong narrative around public health value of the proposed solution.
Our team at TriNetX has deep experience in guiding sponsors through regulatory engagement. We’ve helped shape RWD study designs for FDA Type B and Type C submissions, reviewed protocols, and even joined sponsors in FDA meetings to defend their RWE approach.
Especially with vaccines, there’s a growing interest in studying not just individual shots, but also entire vaccine schedules. Determining whether certain sequences of administration are more effective, or carry more risk, is complex. This kind of work benefits from longitudinal data, strong methodology, robust analytics, and regulatory know-how—all of which TriNetX provides.
“In an evolving regulatory landscape, the companies that succeed will be the ones that are able to convincingly establish and communicate the value of their products more effectively than anyone else. That means using RWD not just to react, but to predict, contextualize, and even negotiate what would otherwise be costly, long-term post-marketing studies.”
Q: What’s the long-term outlook for pharma and public health?
Jeffrey Brown: RFK Jr.’s investigations signal a broader shift toward evidence transparency and accountability in healthcare. Whether you’re dealing with vaccines, antidepressants, or any other therapeutic area, the future belongs to those who can demonstrate the real-world value of their products.
For pharma, that means embracing RWE as a cornerstone of both strategy and science from early in clinical development throughout the product lifecycle and into real-world post-approval utilization. For TriNetX, it’s an opportunity to continue supporting high-quality, robust evidence that’s not only regulatory grade but also grounded in the public health impact of therapies.
“The long game matters in today’s environment. Pharma has to invest in high-quality, long-term evidence, not just to meet regulatory demands, but to genuinely advance public health. That means thinking beyond approval to real-world impact, and being ready with data before someone else defines your product for you.”
Stay ahead of RFK Jr.’s investigations and the evolving regulatory landscape. Explore TriNetX pediatric data.
About Jeffrey Brown, PhD
With more than 25 years of experience in research and consulting, Jeff is an internationally recognized expert in the use of RWD to support the evidentiary needs of regulatory agencies and medical product sponsors and an expert in the assessment of data quality of RWD resources.
