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Back to newsHow Real-World Evidence is Changing the Role of Medical Affairs

How Real-World Evidence is Changing the Role of Medical Affairs

Real-world evidence (RWE) is reshaping the way that the pharmaceutical industry proves value, gets treatments approved, and engages the people who prescribe and use them. As real-world data becomes embedded in how pharma proves value, medical affairs is increasing the function tasked with generating and interpreting it to translate evidence into insights, and the industry is increasingly looking for talent to drive these innovations forward.

Key Takeaways:

  • Real-world evidence is becoming a strategic necessity, driven in part by payers increasingly tying reimbursement to real-world outcomes, and treatments becoming more targeted at biomarker-defined patient groups.
  • Medical affairs now sits at the center of the evidence lifecycle, from designing real-world evidence generation studies to translating findings for HCPs, payers, and patients.
  • The limitations of Randomized Controlled Trials (RCTs) and trends such as the growth of precision medicine, higher demand for better patient insights, and the rise of value-based healthcare are the driving force behind the RWE demand.
  • The talent pipeline isn’t aligned with the demand for RWE and medical affairs professionals, leaving organizations more reliant on outsourcing where possible or specialist consulting to fill gaps.

What is Real-World Evidence (RWE)?

The FDA defines RWE as “the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD)”. Comparatively, real-world data is defined as “Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.”

Data for real-world evidence can come from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources such as digital health technologies.

Real-world evidence contrasts significantly with evidence resulting from randomized controlled trials (RCTs), which traditionally have disadvantages such as being conducted in selective populations in tightly controlled settings, which can reduce findings seen in the broader and more diverse populations in the real world.

Why is Real-World Evidence Becoming More Important in Pharma?

Real-world evidence is becoming a strategic priority across pharmaceuticals, at a time when the global RWE solutions market is projected to grow from $3.1bn in 2026 to $11.9bn by 2035.

A number of trends are driving this shift:

As real-world data becomes embedded in how pharma proves value, medical affairs is increasing the function tasked with generating and interpreting it to translate evidence into insights. This drives an increasing demand for real-world evidence and medical affairs consulting expertise.

Key Applications of Real-World Evidence

When real-world data is generated, it’s applied differently at every stage of a product’s lifecycle, and medical affairs connects these applications together. Real-world evidence transforms raw healthcare data into clinical insights that guide treatment outside of controlled trials.

There are numerous applications:

  • Evidence generation: Medical affairs increasingly leads the design of observational studies and registries that turn real-world data into usable real-world evidence, filling the gaps left by controlled trials (e.g., being able to apply findings to broader populations) and supporting evidence plans from pre-launch through the end of a product’s life.
  • Health Economics and Outcomes Research (HEOR): Real-world evidence supports HEOR teams by demonstrating a treatment’s cost-effectiveness, potential for optimization, and comparative value by using real-world outcomes and cost data, which is critical evidence for payer negotiations and HTA submissions.
  • HCP engagement and education: Medical Science Liaisons use real-world data to provide patient-centered applications, analyzing clinical gaps to tailor peer-to-peer discussions, and gathering field insight that feeds back into evidence strategy.
  • Post-marketing surveillance: Real-world data from EHRs, claims, and adverse event databases can easily enable continuous, population-wide safety monitoring, helping detect rate or long-term signals that pre-market trials are too limited to capture. Rather than relying on a single source, multiple data sources are utilized not just in volume, but in systemic capture.
  • Regulatory submissions and label expansion: RWE featured in a quarter of FDA labelling expansions granted between 2022 and 2024, most commonly in oncology, indicating the shift towards regulators’ willingness to accept RWE alongside trial data.
  • Clinical trial design: Real-world data is now used to build external control arms for single-arm trials, with one glioblastoma study finding this approach cut false-positive error rates up to 30% compared with fixed historical thresholds.

These applications explain the way that medical affairs have become the function best placed to translate real-world evidence into decisions that matter, but more importantly, why organizations are increasingly seeking medical affairs and RWE expertise to spearhead these applications as they evolve.

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How Does Evidence Generation Impact Medical Affairs Strategies?

Beyond the numerous applications of real-world evidence, RWE feeds directly into the core areas of medical affairs strategy.

In scientific communication, MSLs increasingly integrate real-world evidence into HCP dialogue, using tools such as Kaplan-Meier survival curves and forest plots to present findings from diverse patient populations alongside trial data, rather than in place of it. This same evidence feeds publication planning, expanding findings beyond a single trial redout and providing a pipeline of real-world outcomes and subgroup data across the product lifecycle.

Real-world data also shapes medical strategy development, identifying gaps early and deciding which studies, registries, or partnerships to prioritize as a product matures. Subsequently, treatment value is also demonstrated clearly. Real-world evidence lets medical affairs show a therapy’s real-world performance to HCPs and payers, underpinning value-based conversations that trial data alone can’t carry. Additionally, RWE gives medical affairs a shared and credible evidence base for stakeholder engagement.

With this in mind, medical affairs is the bridge between clinical development, healthcare professionals, and patient outcomes. By translating real-world evidence into strategy, rather than simply reporting it, medical affairs is the critical foundation.

How Can Real-World Data Improve Clinical Trial Outcomes?

Real-world data has a multitude of advantages for clinical trial outcomes, many of which overcome the traditional barriers of RCTs:

  • No strict eligibility criteria, with fewer chances of no exclusions based on concomitant medications and comorbidities.
  • Quicker, more cost-effective processes, with less time required for patient recruitment/enrollment and completing the research.
  • Possibility of undertaking research that can’t be done with RCT, such as on high-risk groups like pregnant women and children.
  • Ability to track real-world patient behavior, with rapid and more straightforward retrieval of and access to data.

These benefits align with broader clinical development trends: shorter timelines, more representative enrollment, and evidence packages built around real-world data from the beginning.

How Does Real-World Evidence Impact Drug Approval Processes?

Since 2016, RWE has been featured in 25 FDA drug, biologic, and vaccine applications and over 250 device authorizations, with the FDA removing a major barrier to submitting real-world data in reviews back in December 2025.

Real-world evidence is filling gaps that trials can’t, whether it’s rare subgroups or real-world dosing patterns, and subsequently, RWE is supplementing clinical trial data. Research has indicated that most approvals where RWE studies affected decision making were in oncology, infectious disease, and neuroscience. There is substantial drug development effort in each of these areas, and the issues around small patient populations, impracticality of randomized trials, and ethical issues of placebo control arms make RWE use much more favorable.

Long-term safety is another area of drug approval processes where RWE is emerging as a potential solution. Regulators are increasingly relying on real-world data from EHRs and claims to track a treatment’s safety profile beyond the initial trial period, helping them to catch signals that only emerge at scale or over time.

Regulatory answers are faster, too, with DARWIN EU studies now taking a median of four months from protocol approval to results, which is faster than traditional RWE approaches and supports more opportune integration into regulatory timelines.

The Growing Demand for Medical Affairs and RWE Expertise

Medical affairs and real-world evidence roles are two of the most in-demand life sciences roles in 2026, with a demand that is outpacing the supply, particularly for specialists such as epidemiologists, biostatisticians, RWE specialists, MSLs, and medical affairs professionals.

US Bureau of Labor Statistics data projects epidemiologist roles to grow 19% between 2025 and 2035, and statistician roles, including biostatisticians, by 10%. This outpacing of average job growth isn’t exclusive to in-house roles, either. The global medical affairs outsourcing market, spanning MSL support, medical writing, and medical information, is projected to grow from $2.9 billion in 2026 to $9.6 billion in 2035, as organizations look to fill talent gaps by outsourcing evidence-generation expertise.

It’s never been more essential to understand the current hiring landscape for these highly-skilled roles in order to secure the talent to maintain the increasing growth industry-wide.

Why Partner with Redbock?

Redbock is a leading life science consulting firm; we provide a specialist approach to resourcing solutions, with over 600+ active consultants across the world, backed by a global framework. We have the experience and resources needed to expand your team even during high-demand and low-supply hiring markets.

If talent bottlenecks are making it difficult for you to source specialist talent such as medical affairs professionals, MSLs, epidemiologists, and RWE specialists, get in touch with Redbock today to fill gaps and expand your team.