Why Mortality Data is Important for Clinical Trials 

Clinical trials are the cornerstone of medical innovation, yet they are notoriously expensive and failure-prone, often due to the immense costs of patient recruitment and long-term data gathering. This reality has spurred a movement to leverage Real-World Data (RWD) to make trials faster, cheaper, and more representative. 

However, a critical data gap threatens to undermine this progress: the lack of substantial, long-term mortality information within standard clinical RWD sources (e.g. electronic health records (EHR) and claims). To truly measure the efficacy of new drugs and fully realize the promise of Real-World Evidence (RWE), this mortality data gap must be closed. 

Use Cases for RWD in Clinical Trials 

The shift toward leveraging RWD has fundamentally changed the clinical trial landscape, accelerated by the 21st Century Cures Act of 2016. Life sciences companies and the FDA are keenly focused on RWD/RWE to replace or augment traditional data collection, particularly in:  

1. External Control Arms (ECAs): RWD representing the standard of care can be used as a control group, drastically reducing the number of patients who must be enrolled in a costly (or unethical) placebo arm of a trial. 

2. Pragmatic Studies: RWD allows researchers to assess a drug’s performance in new, real-world circumstances without the need for a formal, resource-intensive clinical trial (e.g., evaluating off-label uses). 

3. Post-Marketing Surveillance: After a drug is approved, the FDA often mandates tracking its long-term safety in larger and less-controlled populations. RWD provides a cost-effective mechanism for this ongoing surveillance. 

The Mortality Data Blind Spot: Why RWD Alone is Insufficient 

For all three of these use cases, a complete picture of patient outcomes is vital. Efficacy and safety are not just about adverse events or short-term clinical markers; they are fundamentally about long-term survival and quality of life. 

• Transactional clinical RWD sources (EHRs, claims) simply do not include sufficient mortality data 

• Without comprehensive mortality data, researchers cannot accurately document long-term survival statistics or holistically measure the full efficacy and safety profile of an intervention over time 

• This lack of long-term survival data hinders the ability to create robust RWE that can support new drug approvals 

Augmenting clinical RWD with external mortality data is the critical improvement needed to drive faster trials and achieve significant cost savings in the multi-billion-dollar clinical trials industry. 

Mortality Endpoints Are The New Standard 

Closing the mortality data gap is no longer optional; it is critical. The FDA’s new guidance requiring the measurement of survival as a key outcome in many RWE-supported submissions underscores the immediate need to address this gap. By augmenting clinical RWD with high-quality, comprehensive mortality data, the industry can meet regulatory demands, unlock a truly holistic view of patient journeys, accelerate trials, and generate the definitive RWE required for regulatory success.