Rethinking Clinical Trial Recruitment to Adapt to Real-World Data

In this article

Clinical trial recruitment remains one of the most persistent challenges in drug development. Despite years of effort to simplify protocols and streamline operations, up to 80% of clinical trials still fail to meet enrollment targets. This failure results in costly delays, missed opportunities and increased financial pressure, especially in today’s volatile healthcare landscape.

But should this be the standard we accept and plan for?

At Optum Life Sciences, we believe it’s time to challenge the status quo. Recruitment shortfalls are not inevitable — they’re often the result of protocol designs that don’t reflect how care is delivered in the real world. And that’s where real-world data (RWD) can make a transformative difference.

Complexity with clinical trial protocols is the culprit

Over the past decade, clinical trial protocols have grown increasingly complex. The average trial now includes 26 endpoints, a 33% increase that strains both patients and sites. This complexity manifests in narrow eligibility criteria, excessive testing and procedures that don’t align with routine clinical care.

For example, protocols often include lab tests — like serum erythropoietin — that aren’t routinely performed in everyday practice. Without historical reference points, sites struggle to predict screen failure rates, leading to inefficient clinical trial recruitment and wasted resources.

Real-world data: A smarter way to design trials

Real-world data offers a powerful lens to evaluate and optimize protocol design. By analyzing how eligibility criteria impact the patient funnel, sponsors can make informed decisions that increase recruitment and diversity.

Consider this: instead of requiring normal kidney or liver function as an inclusion criterion, why not exclude patients with abnormal results? This subtle shift allows patients without recent lab tests to remain eligible, expanding the pool and improving inclusivity.

RWD also helps answer critical questions:

Are certain lab tests or procedures routinely performed in clinical care?
How do providers interpret and document diagnoses in EHRs?
What medications or clinical notes can confirm disease severity or subtype?

For instance, if you're recruiting for moderate to severe asthma, RWD can identify patients with unspecified asthma diagnoses who receive oral corticosteroids a strong indicator of severity.

Bridging the gap between protocol and practice

Clinical sites rely on electronic health records (EHRs) to assess patient eligibility. If criteria are too rigid or misaligned with how diagnoses are documented, recruitment suffers. Real-world data enables sponsors to design protocols that mirror real-world workflows, making it easier for sites to identify eligible patients.

This includes:

Using structured and unstructured data to validate diagnoses
Consulting with healthcare providers and investigators before trial initiation
Ensuring criteria are interpretable and actionable within EHR systems

Beyond recruitment: RWD across the lifecycle

The value of real-world data doesn’t end with protocol design. It can support:

External comparator arms for regulatory submissions, for example, when it’s not feasible or ethical to use an internal control.
Post-marketing observational studies to assess real-world efficacy
FDA-required post-approval commitments

RWD provides a comprehensive view of the patient journey, helping sponsors make data-driven decisions at every stage of the product lifecycle.

It’s time for clinical trial optimization

Trial optimization should begin before initiation, not after recruitment stalls. By leveraging RWD and engaging stakeholders early, sponsors can design trials that are:

Scientifically rigorous
Practically feasible
Patient-centric

At Optum Life Sciences, we’re committed to helping our partners rethink clinical trial recruitment and protocol design. Let’s move beyond outdated standards and build clinical trials that reflect the realities of modern healthcare.