How Real-World Data Can Inform Clinical Decision Making and Patient Care

Real-world data (RWD) and real-world evidence (RWE) go beyond mere buzz words – they play an important role to help understand the safety, effectiveness and value of healthcare interventions in everyday practice.

Today, RWD generation has evolved into a true "end-to-end" capability with 90 percent of global life sciences executives saying their organization is attempting to leverage such information for decision-making across a product’s life cycle. One study found that 116 of 378 FDA-approved New Drug Applications or Biologics License Applications incorporated RWD/RWE in the submission, with the proportion of approvals incorporating RWD/RWE increasing each year between 2019 and 2021.

Summarizing information from RWD represents a paradigm shift in how clinical research is conducted – helping life sciences and medical device organizations support research efforts, ensure regulatory compliance and develop novel medical solutions that meet uncharted patient needs.

This type of robust data generation in action can be seen through the partnership between PINC AI™ Applied Sciences (PAS) and Gilead Sciences.

Premier spoke to Essy Mozaffari, Senior Director of Global Medical Affairs at Gilead Sciences and Denise Juliano, Group Vice President of PINC AI™ Applied Sciences to learn more about how PAS and Gilead are leveraging information from routine clinical practice to inform patient care and potential outcomes.

The following is a question-and-answer format conducted in an interview between Premier and Essy and Denise.

Why is RWD important?

Denise: Researchers around the world are using RWD to advance our understanding of the impact of healthcare interventions implemented in clinical practice and answer questions about how these therapeutic interventions affect health outcomes.

For example, what evidence exists that drugs, vaccines and devices are delivering value by doing what they are intended to do? What characteristics might predict whether individuals are more or less likely to experience an outcome while using a specific product? Do certain therapeutics have other impacts, such as reducing administrative burden or costs?

While randomized clinical trials (RCTs) remain a strong tool for assessing a medicine’s efficacy and safety, RWD provides important insights on a treatment’s impact in routine clinical practice that can complement findings from RCTs.

Essy: I am excited to see how this field evolves. RWD generated through the Gilead-PAS partnership is advancing scientific knowledge in areas of unmet medical need – with communication of evidence in real-time to clinical practitioners.

We are seeing more regulatory submissions that include RWD to demonstrate product safety and efficacy, provide therapeutic context, and support expanding label indications and guidance for treatment. A key example of this is using RWD to assess the impact of a therapeutic intervention in populations not studied in an RCT.

We are leveraging the PINC AI™ Healthcare Database (PHD) to conduct evidence-based and population-based analyses among hospitalized individuals. This high-quality data source and the resulting findings give us insights into how clinicians are treating patients and what outcomes are being realized in practice across the United States.

Can you provide an example of how RWD has made an impact on patient care through the Gilead-PAS partnership?

Essy: Throughout the COVID-19 pandemic, RWD was invaluable to the scientific community as clinicians were faced with a new, rapidly evolving disease with no natural history.

One comparative effectiveness study using PHD data investigated the effect of treatment with an antiviral on inpatient mortality among immunocompromised patients hospitalized for COVID-19 across all variants of concern periods. This research can impact patient care and has informed updated treatment guidelines from the National Institutes of Health (NIH) for people who are immunocompromised and may be more susceptible to severe COVID-19 outcomes.

With the updates to the NIH guidelines, healthcare providers now have recommendations backed by RWD on how to treat immunocompromised patients in a real-world setting. And while there is still a need for more data and research, this provides clinicians with key insights to help inform how to treat these vulnerable populations.

Denise: Complementing insights from RCTs, RWD is helping Gilead and other organizations better understand the burden of disease states as well as the financial and clinical impact and benefit of certain drugs, devices and treatments. Simply put, it can be a game changer for advancing patient care delivery and outcomes.

How does PAS-Gilead generate evidence from routine clinical practice and how is this different or unique?

Denise: Artificial intelligence (AI)-enabled RWE generation is picking up pace.

We are partnering with Gilead and other life sciences organizations to leverage PAS’ AI capabilities – including RWD coupled with machine learning (ML) and natural language processing (NLP) – enabling speed-to-value and a data-driven understanding of disease progression, early disease identification and intervention, and the segmentation of patients to appropriately match them to RCTs. With AI-enabled RWD, clinical research timelines can be shortened, and solutions have the potential to be delivered at reduced costs.

Essy: RWE is only as good as the data from which it’s sourced. To evaluate the RWE necessary to assess a therapy’s intent and value in the clinical setting, life sciences organizations need different sources of data, which when brought together, generate actionable information.

For Gilead, the PHD is a differentiated source for conducting observational research among hospitalized individuals across a range of U.S. hospitals and a wide number of patient outcomes. It includes patient, hospital and clinical characteristics, costs and charges, laboratory data, vitals, treatment and diagnoses – from approximately 1,300 healthcare sites and over one billion individual patient encounters.

What does the future look like for the partnership?

Essy: At Gilead, we’re working to advance our strategy to deliver solutions that can improve patient outcomes – and we continue to pursue bold ambitions for research and development across multiple therapeutic areas.

Importantly, the PAS team and Gilead also share a strong commitment to evaluate and communicate healthcare inequities that patients face. For example, we’re characterizing disparities in the administration of evidence-based COVID-19 treatments among patients hospitalized for COVID-19. The hope is that this research can assist clinicians, policymakers and regulators to further inform equitable treatment, patient care and patient outcomes for diverse patient populations.

Denise: The PHD will continue to provide life sciences partners like Gilead the opportunity to use RWD to conduct evidence-based studies of drugs and clinical outcomes in an effort to inform the overall quality, safety and cost-effectiveness of care.

And like Essy said, our focus goes beyond the therapy – we strive to progress health equity and break down barriers to care. We empower our people to tackle these challenges, and we’re all united in our commitment to help millions of people live healthier lives.

By incorporating RWD into decision-making processes, life sciences executives have the potential to make a lasting impact, revolutionizing healthcare for the betterment of patients worldwide.

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