Note: This is the third article of a three-part series.
Real-world evidence (RWE) plays a crucial role in supporting the benefits of one drug over another in debates that play out on the boards and committees overseeing hospital and payer formularies. It influences how much pharmaceutical companies can charge for their drugs and which ones are covered by payers. RWE also shows how treatments perform in routine clinical settings. It includes measurable improvements in patient outcomes, enhanced quality of life, and reductions in healthcare costs. This allows companies to make more informed decisions between pricing strategies and market access goals.
RWE also includes data that go beyond the efficacy data from controlled trials.
If pharma companies are to ensure the effectiveness of their drugs for the widest portion of a patient population, they first need to understand the personal challenges members of these patient populations face. The digitization of data has enabled the aggregation and analysis of real-world data (RWD) to generate insights through a RWD platform.
Using RWD to understand and map social determinants of health (SDOH), highlighting the challenges patients with non-small cell lung cancer (NSCLC) face paves the way for improving health equity not only across the NSCLC patient population, but other conditions as well. This, in turn, leads to clinical trial designs that enable more successful patient recruitment. A clinical trial that uses RWD insights increases the diversity of the patients in a clinical trial and leads to drugs that help a wider range of patients with NSCLC. By using RWD to understand and mitigate SDOH barriers, pharmaceutical companies can expand their addressable patient population, improve treatment adherence, and ultimately drive greater market uptake and revenue.
By analyzing demographic and geographic data, pharma companies can plan clinical trial sites that are more convenient for patients targeted for the study. They can build bilingual, bicultural teams to better engage community stakeholders and build trust.
In a recent webinar by MedCity News and PurpleLab®, Steven Emrick, PurpleLab senior vice president of clinical informatics solutions and HealthNexus®, observed that improving health equity and revenues are not mutually exclusive.
“I think if you’re not addressing the health equity piece, then you are missing out on part of your mission as a life sciences company,” Emrick said. “You’ve got to be inclusive, you’ve got to look at the patient populations for whom you’re developing therapies. That’s good for your business, that’s good for your brand to be more inclusive in terms of how you design your clinical trials. Don’t think those two things are mutually exclusive – a public health goal and a revenue goal.”
RWD can inform the design of more inclusive trial eligibility criteria, optimize site selection, and enhance recruitment strategies. This leads to more diverse and representative trial populations, ultimately yielding more generalizable and robust results that are applicable to a broader patient base.
Ben Freiberg, principal Informatics systems lead with Genentech’s GCS Computational Catalysts, shared his perspective on clinical trial design challenges during the webinar. He explained that pharma companies and their partners have to design clinical trials to take place in areas where there are people with experience in managing clinical trial sites, typically an academic medical center. More often than not, these tend to be located not in rural areas but within or near a metropolitan area.
“The more we know about the demographics of a disease, what diseases are occurring where, and specifically how those pathologies are realized, what the environmental factors are, socioeconomic factors, genetic factors, then it becomes much easier to plan your clinical trial and has a higher chance of success,” Freiberg said “That’s because you’ve captured actual patients that could respond to the therapy in that population.”
Leveraging RWD allows for the robust validation of real-world effectiveness. It facilitates the assessment of real-world endpoints such as overall survival, time to next treatment, time to treatment discontinuation, and progression-free survival. Research has shown a connection between real-world endpoints and outcomes observed in randomized clinical trials, validating the use of RWD for informing regulatory and payer decision-making.
PurpleLab’s core value proposition lies in its ability to translate complex RWD into actionable intelligence to support clinical trial design, as well as drive change to standards of care that can improve outcomes. RWD analyses have shown that targeted therapies significantly improve the survival of NSCLC patients with actionable mutations, providing evidence that supports wider access to broad genomic testing and these targeted therapies.
There are several ways RWD can be used to alleviate payer concerns over whether to cover a particular treatment. Among the factors that inform these decisions are:
- Medication adherence
- Cost impact/healthcare resource utilization
- Comparative effectiveness
- Quality of life/symptom burden – which can impact medication adherence
PurpleLab’s RWD platform facilitates seamless collaboration and data-driven decision-making across R&D, commercial, and market access teams, helping to dismantle internal data silos. In doing so, PurpleLab is not just a data provider, but a strategic enabler of organizational transformation, fostering a shared, comprehensive understanding of the patient journey that drives holistic business growth.
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