Real world evidence (RWE) is playing an increasingly important role across the clinical development lifecycle, as sponsors look for new ways to improve trial efficiency, support regulatory decision making, and address growing scientific and operational complexity. According to the IQVIA Institute Global R&D Trends 2026 Report: Advancing Innovation in a Changing Landscape, real world evidence is no longer a supplemental data source. It is becoming a practical and influential component of modern drug development.
As trials grow longer, more complex, and more costly, real world data and evidence are being used to complement traditional clinical trial approaches, support approvals, and inform evidence generation strategies well beyond launch.
Clinical development timelines have lengthened in recent years, driven largely by longer enrollment periods, increasing trial complexity, and greater scientific uncertainty. The IQVIA Institute reports that median enrollment duration exceeded 16 months in 2025, with oncology trials taking significantly longer than other therapeutic areas.
At the same time, sponsors face pressure to demonstrate value in broader, more diverse patient populations while controlling development costs and timelines. Real world evidence offers a way to bridge the gap between tightly controlled clinical trials and real clinical practice by drawing on data from electronic health records, administrative claims, registries, and other routine care sources.
This evidence helps sponsors understand how treatments perform outside the constraints of traditional trials and allows development programs to be designed with greater clinical relevance from the outset.
The Global R&D Trends 2026 Report highlights the growing regulatory acceptance of RWE, particularly in situations where randomization is not feasible or unethical and where there is a high unmet medical need.
In 2025, real world evidence contributed to seven FDA approvals, using a range of approaches that included observational studies, external controls, and contextual safety and effectiveness data. These approvals were most common in rare diseases and oncology, where patient populations are small and unmet need is high.
Importantly, RWE is not limited to initial approvals. It is increasingly used to support label expansions, new populations, and indication modifications, allowing sponsors to extend the value of approved therapies more efficiently.
The IQVIA Institute summarized that, to date, real world evidence has been more commonly used to complement traditional randomized controlled trials. In many cases, RWE enhances trial design, improves feasibility, and strengthens the overall evidence package.
Examples include using real world data to inform eligibility criteria, benchmark standard of care arms, identify appropriate endpoints, or provide external comparators for single arm studies. RWE can also help explain differences between trial results and real world outcomes, improving confidence among regulators, payers, and clinicians.
As novel trial designs become more common, including adaptive and pragmatic approaches, real world data is increasingly used to support decision making across development stages.
One of the most compelling benefits of generating real world evidence is its potential impact on development efficiency. The report notes that compressed or consolidated development programs, often supported by non traditional evidence strategies, can shorten timelines by several years compared with conventional development paths.
Real world data can help sponsors identify viable patient populations more quickly, reduce recruitment risk, and optimize site and country selection. Real world evidence can support earlier go or no go decisions by providing insight into disease progression, treatment patterns, and unmet need at scale.
These advantages are particularly important as sponsors manage increasingly crowded pipelines and competition for trial participants continues to intensify.
Clinical trials are designed to answer safety and efficacy questions under ideal circumstances, but they cannot fully capture how treatments are used in routine practice. Real world evidence provides insights into patient heterogeneity, adherence, comorbidities, and long term outcomes that are difficult to observe in controlled trials.
Keeping this real-life perspective is essential for understanding true treatment impact and for demonstrating value to healthcare systems. As trust in data driven decision making grows, RWE is becoming central to discussions around effectiveness, safety, and access.
Sponsors are increasingly developing integrated evidence plans to proactively incorporate real world evidence earlier in clinical development to have discussions with regulators early ensure robust evidence generation from trial design through post approval.
Regulatory frameworks are evolving to better accommodate real world evidence, particularly in the United States. The IQVIA Institute notes continued FDA efforts to publish guidance to clarify how RWE can be used in regulatory submissions, including guidance on the use of electronic health records and medical claims, registries, data standards, and the use of external comparators.
These developments lay out the regulatory expectations to accept high quality real world evidence not only as supportive data but, in certain cases, as substantial evidence. This momentum is expected to grow as data infrastructure improves and methodological standards continue to mature.
Real world evidence is becoming a strategic capability rather than an optional add on. Sponsors that invest in robust RWE strategies are better positioned to manage risk, accelerate development, and demonstrate real world value across the product lifecycle.
Success depends on data quality, methodological rigor, and early integration with clinical development planning. Organizations that treat RWE as a core element of trial design and regulatory strategy are more likely to realize its full benefits.
As clinical development continues to evolve, real world evidence will play an increasingly central role in shaping how trials are designed, how therapies are evaluated, and how innovation reaches patients.
The Global R&D Trends 2026 Report makes clear that real world evidence is no longer peripheral to clinical development. It is a critical enabler of faster, more relevant, and more resilient evidence generation in an environment defined by complexity and competition.
As sponsors balance scientific ambition with operational realities, real world evidence will remain a key tool for connecting trials to real patients, real practice, and real outcomes.
This blog is based on insights from The IQVIA Institute’s Global R&D Trends 2026 Report: Advancing Innovation in a Changing Landscape. For more report information, please visit https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-r-and-d-trends-2026.
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