Advancing precision medicine: How real-world evidence platforms translate data into action

In the era of precision medicine, life sciences teams can utilise real-world data (RWD) to generate actionable real-world evidence (RWE) about how to develop and deliver more targeted medications to the right patients. The task of extracting these insights from diverse data sources, however, can be challenging.

Analytic platforms can harmonise vast amounts of healthcare data into common data models that can be queried for analysis. These tools take many data types – from electronic medical records to genomics datasets to information on the social determinants of health – and organise them so that researchers can generate RWE about patterns in treatment and patient outcomes across different cohorts and populations.

Jason Gagner, vice president of product management at healthcare technology company PurpleLab, understands the impact these insights can have in practice. He explained that PurpleLab’s HealthNexus platform harmonises data sources to enable researchers to more precisely home in on specific cohorts to design precision treatment methodologies.

“We can utilise disparate data to understand the amount of metformin in addition to cardiac medications being prescribed – plus the dosing volume for those patients, information on their medication adherence, and data on any adverse events. This helps us determine how to achieve the best outcomes for those patients within their cohort of a therapeutic area,” Gagner said.

Across the pharmaceutical lifecycle and after a drug enters clinical practice, RWE platforms empower life sciences teams – as well as clinicians and payers – to make informed precision medicine decisions without the need for coding or data science expertise. While analytics and data storage are often siloed across healthcare organisations, platforms like HealthNexus make healthcare information accessible to all relevant colleagues, enabling cross-functional teams to collaborate in one platform via a single analytic language for all their research needs.

We spoke with Gagner to outline the opportunities RWE platforms hold for health economics and outcomes research (HEOR), medical affairs, clinical research, and other teams and stakeholders across the spectrum of drug development and delivery.

Understand medical and economic outcomes in key cohorts

Within real-world datasets are countless roadmaps that life sciences teams can use to track real patients’ health outcomes. According to Gagner, this data can reveal unmet needs to paint a clearer picture of the burden of illness on a cohort of patients. Information about how often patients fill prescriptions or see a clinician can illuminate trends in patient care utilisation and the demand on clinical resources. They can also help predict patients’ outcomes on certain medications based on their health histories and behaviours.

“These are all fantastic measurements that teams use to qualify the efficacy of a treatment or care process,” Gagner said. “We’re able to slice the data by region, providers, and other characteristics to look at differences in outcomes or identify outliers, then use RWE to know the best time to use one medication versus another.”

Optimise clinical trial design for precision medicine

Clinical trials are notoriously slow and expensive, and challenges deepen for highly targeted medications. RWE platforms enable teams to optimise clinical trial design with data before recruiting actual patients. Gagner illustrated how users can drill down into where and how cohorts of patients are treated to understand the best sites to recruit from. Teams can also test hypotheses, evaluate market potential, and assess their trial’s feasibility in RWD before they conduct a clinical trial, saving significant time and resources.

“By being able to test protocols and study designs against the data, we can identify screening criteria that may make the study too restrictive, thus leading to high screen failure rates,” Gagner said. “If we find that certain criteria were too restrictive, we can work with pharmaceutical companies to adjust their screening protocol, so the target patient group will fit the inclusion criteria.”

Define brand opportunities and maximise brand value

As each delay in getting a drug to market can cost between $600,000 and $8 million, pharmaceutical companies can’t risk wasting time in the lead-up to product launch. Gagner explained the imperative to use RWD to identify brand opportunities and launch as quickly and effectively as possible.

“What delays in clinical trials really mean is that a patient who would benefit from the treatment will have to wait longer,” Gagner said. “Choosing not to utilise RWD to improve quality and efficiency doesn't feel like an acceptable or reasonable approach.”

By working with RWE platforms that harmonise data related to medication dosing, social determinants of health (SDOH), and other information, teams can gain a fuller picture of their brand’s market opportunities prior to launch, then capitalise on areas where they have the greatest potential to improve outcomes.

“We have found it extremely useful to know what treatments are currently available and their outcomes,” Gagner said. “This helps in setting a threshold for success and determining whether a new treatment performs better than current standards.”

Not only does this improve launch planning, it helps to avoid costly delays and improves probability of success with regulatory agencies.

“Being able to identify challenges or obstacles beforehand, and with a proper amount of time to address the issue, can significantly improve the adherence to clinical trial timelines,” Gagner explained. “In addition, being able to support regulatory requirements and show that a clinical trial was conducted thoughtfully and inclusively, then receive regulatory approval, is significantly more satisfying than having an application rejected because somewhere along the way the focus on the patient was lost.”

Improve care delivery though physician education

Beyond the sphere of drug development and launches, Gagner shared opportunities for RWE platforms to unlock information on how physicians treat patients in the real world, then fill gaps in care and outcomes.

He explained that RWE can reveal variations in outcomes at the facility, local, regional, and national level. When presented to healthcare facility leaders, this information can help them address areas of weakness among their populations through education and training. Equipped with more robust information on outcomes at their facility, healthcare systems can set higher standards for their physicians to strive toward, and physicians can enable better outcomes for their patients.

“Learning and understanding which services and physicians have the best outcomes, as well as the areas of improvement, provides a fantastic opportunity to elevate the quality of care for all patients,” Gagner said.

The path forward for precision medicine

As more RWD sources and RWE generation tools become available, Gagner looks forward to opportunities to automate and streamline analytic processes. As an example, he shared his excitement about reporting tools that can remove the administrative burden from data analyses and expand access to team members without coding expertise.

“We have made it significantly easier for non-coders to get deeper into analyses, which helps reduce the burden on programming staff,” Gagner said, adding that PurpleLab has already rolled out several of these types of reporting capabilities and plans to release additional next-generation reporting tools with expanded capabilities, a greater depth of data, and enhanced user experiences. These tools will compel the market to drive further innovation and take another step toward improved patient care.

Ultimately, continued collaboration between healthcare technologists, industry, payers, clinicians, and technology will be key to improving patient outcomes with deeper data analytics. Gagner sees his and PurpleLab’s role as a partner to the industry being the key to driving precision medicine forward.

“We’re not just a vendor or data source, we’re here as a business partner to our clients,” Gagner said. “When we learn about a client’s challenges with a study, we appreciate the importance of their work and roll up our sleeves to problem-solve together. We are a partner on their journey, and we’ve built a platform that allows that.”

About the interviewee

Jason Gagner started working in healthcare over 25 years ago, building his industry experience in healthcare operations, medical informatics, clinical research, and organisational strategic planning. Gagner has held various leadership roles over the years within healthcare services, as well as commercial research. He and his team of informatics researchers were awarded top honours from US Healthcare News twice while at Intermountain Healthcare, where he oversaw business operations and strategy for the Homer Warner Center of Informatics Research. Prior to joining PurpleLab, Gagner was a senior director at Parexel, where he implemented new data solutions and operational strategies that transformed how data is being used to support all phases of clinical trial work across all therapeutic areas.

Gagner is a member of the American College of Healthcare Executives (ACHE), American Medical Informatics Association (AMIA), Drug Information Association (DIA), Healthcare Information and Management Systems Society (HIMSS), and the Utah Chapter of the Healthcare Information and Management Systems Society (UHIMSS). He has served on various boards providing insight and thought leadership to various healthcare organisations. He has also received organisational awards for mentoring, top producer, leadership, and innovation. Gagner completed two Master’s degrees and graduated with honours for each. He earned his MBA from Vanderbilt University and his MSc in Biomedical Informatics from the University of Utah School of Medicine.

About PurpleLab

PurpleLab is a healthtech company with a mission to make healthcare speak a single unified language to drive better outcomes. HealthNexus, our no-code healthcare analytics platform, empowers life sciences, payers, providers and other stakeholders with real-world evidence to solve conventional and emerging challenges faster and more cost effectively.