Real-World Evidence Doesn’t Need More Data. It Needs Better Reach.

The real-world evidence industry has spent two decades getting better at one thing: extracting more data from the historical record. Claims databases have grown deeper. EHR networks have grown wider. Registries have grown more specialized. Sponsors, payers, and regulators have access to more retrospective data than at any point in the history of life sciences research. Nearly all biopharma companies, 96% in Deloitte’s latest benchmarking survey¹, plan to increase real-world data and evidence investment over the next two to three years, underscoring how central these assets have become to industry strategy.

And yet the questions keep getting harder to answer. The reason isn’t a data problem. It’s a reach problem.

A historical record can tell you what happened. It struggles to tell you what’s happening now. It can capture treatments that have been prescribed, outcomes that have been documented, and patients who have been seen, but it cannot capture the questions that emerge after the data was collected. As therapeutic areas grow more complex, as label expansions require longer follow-up, and as payers demand evidence on real-world durability and adherence, the gap between what retrospective data can answer and what stakeholders actually need is widening. A landmark JAMA Network Open analysis found that none of the 50 FDA-required postapproval confirmatory trials granted accelerated approval between 2009 and 2018 could be feasibly emulated² using existing claims or structured EHR data. The gap between what the industry has and what the industry needs is not theoretical. It is documented, persistent, and growing.

The problem is structural. Most RWE programs operate on a one-way pipeline: data flows from the health system to the analyst, gets cleaned and aggregated, and is analyzed for whatever question is on the table today. When a new question arises tomorrow, the cycle starts over. The patient, meanwhile, has moved on, switched therapies, experienced an outcome, or been lost to follow-up entirely. The evidence is always a step behind the decision. Sponsors report time delays of up to six months in accessing certain claims data³, making real-time decision-making during drug development functionally impossible.

More data won’t fix this. Another claims feed, another EHR partnership, another registry won’t close the gap, because the gap isn’t about volume. It’s about whether you can reach the patient when the question arises, not just when the record was created.

That requires a different kind of infrastructure. When research capability is embedded in the clinics where patients actually receive care, through site management organizations, practice partnerships, and the operational presence to follow patients over time, evidence generation stops being a backward-looking exercise. New cohorts can be assembled around emerging questions. Outcomes can be captured as they unfold. Patient-reported insight, biomarker data, and treatment changes can be collected as care happens, not reconstructed after the fact. The patient journey becomes a living asset, not a historical artifact.

The implications cut across the evidence value chain. Sponsors get faster answers to the questions driving label and lifecycle decisions. Payers get the durability and adherence data they’ve been asking about for years. Regulators get the post-approval evidence the new generation of accelerated approvals depends on, an expectation now formalized through the FDA’s Advancing Real-World Evidence Program and 21st Century Cures Act framework. Site networks get a new revenue stream and a more strategic role in research.

The industry isn’t short on data. It’s short on reach, the kind of relationships that turn data into living evidence, and the kind of infrastructure that takes years to build.

At BEKhealth, we built our model around this reality. Our foundation is deep, long-standing partnerships with site management organizations and physician practices, not licensing agreements with data aggregators. That distinction matters. These relationships give us the operational presence to assemble cohorts faster, follow patients forward as care evolves, and capture the clinical signal, biomarker data, and patient-reported insight that retrospective datasets cannot generate. They are not relationships you can buy off the shelf or rebuild on a timeline. They are how we power real-world evidence built for the questions sponsors and payers are asking today, and ready for the ones they’ll ask tomorrow.

Sources cited in this post:

1. Deloitte. “Real-world evidence’s evolution into a true end-to-end capability.” Deloitte Center for Health Solutions. Accessed June 2026.
2. Wallach JD, Zhang AD, Skydel JJ, et al. “Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.” JAMA Network Open. November 9, 2021.
3. Applied Clinical Trials. “The Evolution of Real-World Evidence: Moving Beyond Claims Data in Clinical Trials.” April 15, 2026.
4. U.S. Food and Drug Administration. “Real-World Evidence.” Accessed June 2026.