Understanding how medical interventions impact patients has always been a top priority for biopharma organizations. And as the industry sees an increased push toward using patient-relevant data to inform clinical development and commercialization strategies—including primary data collected directly from patients, physicians, and trial sites—organizations have access to new tools to generate real-world evidence (RWE) that shines a light on patients’ lived experiences outside the controlled environment of clinical trials.
Syneos Health and Aetion recently announced a partnership that offers Syneos Health’s primary data collection resources combined with analytics on Aetion Evidence Platform® (AEP) to enable customers to generate RWE across the product lifecycle. From early in clinical development through product launch, the joint offering allows customers to better measure the impact of interventions on patients and, ultimately, improve patients’ access to the treatments they need.
We spoke with Javier Jimenez, MD, MPH, Executive Vice President of RWE and Late Phase at Syneos Health, about the importance of combining primary data with other types of real-world data (RWD) to strengthen R&D and commercial strategies, and how the Aetion-Syneos Health partnership can enable this work.
Dr. Jimenez is a physician, an epidemiologist by training, and a public health expert. He’s spent the last 20 years building RWE programs, both in large biopharma companies and now at Syneos Health where he builds individualized RWE solutions for customers.
Responses have been edited for clarity and length.
Q: Tell us about Syneos Health’s data collection resources. How do you curate the data, and what kinds of data do you make available to customers?
A: Syneos Health focuses on primary data collection, gathering data from clinical trial sites, patients, and physicians. We’ve been working to design and develop a methodology that allows us to collect data in the least disruptive way possible for patients and physicians. For example, we use technology systems that allow patients to easily enter information—electronically capturing evidence required for decision-making through e-diaries and patient reported outcomes, for instance. We then work with our data management and biostatistics teams to integrate all this data, clean it, analyze it, and provide it back to clients in a consolidated format to support clinical reporting and publications as needed.
My team works with RWE and focuses on the observational space. We’re interested in connecting observational and primary data to create a research environment that’s as close as possible to true patient care.
Q: How have you seen biopharma organizations join primary data with other types of RWD to deliver on R&D strategy and goals?
A: Biopharma companies are increasing their interest in generating patient-relevant evidence. Traditional clinical trials focus on understanding the efficacy and safety of a product in an experimental environment, but we need different types of data to understand how a product will perform when it’s on the market.
As such, biopharma organizations incorporate primary data with RWD to generate RWE across the product lifecycle. They may use natural history studies to more fully understand the patient population, unmet medical need, or disease progression to inform the design of their clinical development programs. Some use real-world insights to increase the efficiency of product delivery by improving the patient identification and patient recruitment processes. Others may incorporate RWE into clinical projects, for example, by accelerating clinical studies with external control arms, or by incorporating RWE into long-term follow up with patients to increase their engagement and retention in clinical trials.
Q: What are the main factors that drive RWE strategy within biopharma organizations, from your experience? And what does success look like?
A: One of biopharma organizations’ main goals is understanding the impact a product has on patients, then using that information to deliver the evidence required by various stakeholders—from regulators to payers to physicians—to ensure a product is approved, funded, prescribed, and taken by the patient. In the end, this improves patient outcomes, and biopharma organizations can ensure their product really can make a positive impact on a patient’s care.
In the past, we’ve seen some products gain regulatory approval, but not be funded by payers or prescribed by physicians. In this case, the products don’t make an impact on patients. It’s important that we can transfer knowledge from the clinical trial into patient care, and this is one of the key factors that drives RWE strategy.
Success, ultimately, means increasing patients’ access to the treatments they need. This can be achieved by delivering the required evidence at the right time to answer decision makers’ questions.
Q: Why is Aetion Evidence Platform® well suited to integrate primary data and RWD to streamline analyses for customers?
A: One of the key criticisms of RWE in the past has been around the quality of the methods used to approach RWD analyses. In the last 10 years, we’ve seen the field evolve to focus on the credibility of RWE, and on applying the appropriate methodologies to transparently analyze data while avoiding bias.
This is the strength that AEP and the Aetion team bring to the table—a sound methodological approach that ensures transparency in how data is analyzed, and that enables researchers to communicate all steps of the analysis to various stakeholders.
In addition, AEP can incorporate data from any source—including clinical trial data, observational data, and secondary data from health care databases—and apply the same methodologies consistently across data sources with transparency. This is helpful in ensuring analyses can be replicated, as you can go in depth to understand how the data was analyzed. You can feel confident that if you apply the same methodology again, you’ll obtain the same results.
Q: How do you see the Aetion-Syneos partnership creating value for biopharma?
A: Together, Syneos Health and Aetion are enabling clients to generate evidence that could help inform a more impactful clinical development program, deliver products to patients faster, and tailor offerings to patients’ particular needs. We can empower market access and medical affairs teams to communicate findings to stakeholders, and work with commercial teams to understand how their resources are allocated, identify areas of unmet medical need where their product could make a bigger impact, and gather the evidence medical science liaisons need to communicate to physicians.
We can help our customers realize the full potential of RWE to address their needs and answer their most important research questions. Whether it’s a retrospective analysis, a secondary data analysis, or a pragmatic trial, we can offer the fullest spectrum of RWE solutions, consolidate the data, and analyze it in an efficient way to achieve the best outcomes for customers in their communications with stakeholders. Our partnership allows us to enable a data-driven decision-making approach to clients across the product lifecycle, accelerating product development and patient access and, ultimately, improving the health of the patient.
Q: What does it mean to you to offer an end-to-end RWE solution?
A: There is a misconception that RWE can only be used post-commercialization. But being able to generate RWE early in the product lifecycle offers great opportunities to inform clinical development programs as well as clinical trial design, and to create efficiencies in the development process that reduce costs, shorten timelines, and more effectively demonstrate the value of the product. This evidence can help biopharma better understand the outcomes they need to measure in clinical trials to instill confidence in physicians, payers, and patients, and apply this knowledge to the product’s launch.
Clinical development teams can transfer this knowledge to the commercial team to understand the best way to communicate and execute a commercial strategy that ensures the greatest impact for the product in the market—and in real life for patients.