Harnessing RWE for Post-Pandemic Healthcare: Accelerating Drug Development with Real-World Data
Med City News
The Covid-19 pandemic impacted virtually every industry, with healthcare arguably undergoing the most drastic transformation. Pre-pandemic, most of us never could’ve imagined routine doctor visits happening over telehealth, or a brand-new vaccine being developed, tested, and authorized for emergency use in under a year. The urgency of the pandemic forced medical scientists and researchers to get creative and develop new treatments — fast.
How the pandemic changed what’s possible with RWE
The value of real-world evidence (RWE) and real-world data (RWD) quickly became apparent, and it was integral to understanding vaccine safety and efficacy. The U.S. Food and Drug Administration (FDA) released pandemic-focused RWE guidance documents and funded and initiated projects to support Covid-19 research through RWE and platform studies. As a result, the vaccine development process—which generally takes 10-15 years — was compressed to under one year, giving patients rapid access to an FDA-approved vaccine that met rigorous testing criteria.
Nearly overnight, RWE shifted from a “nice to have” complement to clinical trials to a core element of the drug development process. This pandemic-motivated change is here to stay: Last year, 82 percent of submissions to the FDA included RWE, and the agency approved 15 percent more drugs based on RWE submissions in 2024 than the year prior. The FDA has provided pharmaceutical companies with a checklist to follow when incorporating RWE and updated its website with additional information and guidance—signifying RWE’s permanent role as a crucial innovation-driver.
As RWE continues to influence the future of drug development, pharma companies will inevitably encounter hurdles. But with the right approach, they can be overcome to unlock critical insights and bring better therapies to patients faster.
The challenges of working with RWE
Despite its promise, pharma still faces three systemic barriers to realizing RWE’s full potential.
- Data ingestion and harmonization issues. Acquiring data sources isn’t just a substantial financial investment; it demands a large time investment as well. After pharma companies purchase those data sources, they need to dedicate considerable time to preparing said data for analysis. Data coming from different sources — with disparate schema — can cause harmonization challenges that slow time to insights and delay the drug development process.
- Privacy constraints and inconsistent local data-access rules. Pharma companies typically purchase data under strict usage constraints that are limited to certain geographies, indications, or time periods. Often, they must manually ensure the data is being used properly within those constraints, which can drastically slow cross-site analyses and hinder global collaboration.
- Traceability challenges. Ensuring traceability from data source through analysis remains a persistent challenge even though it’s required by regulators. To meet this standard, pharma companies need the proper pipelines to support reproducibility, and all analyses should be conducted within a validated toolset — not a local notebook on a developer’s laptop. When the drug development process isn’t traceable, pharma companies become more susceptible to regulatory risk and face slower approvals.
Maximizing the impact of RWE demands the right tools and approach
As RWE becomes increasingly central to drug development, pharma leaders must invest in interoperable platforms, enforce reproducibility, and empower teams with real-time insights. One way they might do this is by transitioning from static, PDF-based RWE reports to more interactive, model-backed tools and platforms.
What does this look like in action? Instead of waiting weeks for a developer to re-run code to view a slightly different analysis, pharma stakeholders can instead use an interactive dashboard to update analyses instantly. Additionally, since all analyses are done by the system (not by individual developers working in local notebooks), it has the added advantage of built-in quality control, governance, and reproducibility.
This benefits pharma companies in the following ways:
- Increases hypothesis agility by enabling clinicians to test niche sub-populations on the spot, ultimately accelerating speed to decisions.
- Fosters increased trust by letting stakeholders quickly and easily see how analyses are conducted.
- Provides a single source of truth in the form of a dashboard everyone can see, which cuts down on conflicting sources that slow progress.
- Streamlines compliance by providing regulators with data (not documents) to review — including everything from visualizations to underlying code—all in one place.
Final thoughts on harnessing RWE for post-pandemic healthcare
For the best chance at successful outcomes using RWE, pharma companies should “start with the end in mind.” This means designing studies with the assumption that RWE will indeed be included in the submission, and baking that into the statistical analysis plan from the get-go.
It’s also crucial to inventory and prepare for the data sources required to support this — and start building the right tech stack early. Finally, pharma companies should communicate with regulators early to receive guidance on their approach. The pandemic may be five years behind us, but the speed, agility, and impact it unlocked through RWE must define the next decade of drug development.