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New federal guidelines for real-world evidence, an expanding market for biosimilars and continuing site of care shifts represent just some of the major market forces influencing the life sciences landscape this year, according to a recent analysis from Optum Life Sciences and Advisory Board.

“In a complex and competitive marketplace, it’s vital to stay on top of the trends in the health care ecosystem that are most likely to impact clinical, commercial and broader evidence-generation strategies throughout the year,” said Sheenu J. Kachru, chief executive officer, Optum Life Sciences.

Based on conversations with over 100 evidence generators, data scientists, researchers, clinicians and decision-makers across the health care ecosystem, the analysis identifies seven trends that ripple across the health care ecosystem, including:

Writing the next chapter in Real-World Evidence (RWE)’s history

The expanded guidance from the U.S. Food and Drug Administration (FDA) on the use of RWE in regulatory decision-making has opened the door for more pragmatic approaches to trial design, more inclusive methods for participant recruitment and earlier stakeholder input into clinical programs writ large. Life sciences companies may need to nurture more cross-functional collaboration and develop more holistic evidence plans as part of a larger strategy to capitalize on these new opportunities.

Targeting the opportunities in precision medicine

Most organizations continue to underestimate what’s required for market success with targeted therapies. Strategic investments in real-world genomic, economic, clinical and behavioral intelligence can help life sciences companies optimize the opportunity and promise of precision medicine.

Unlocking the value of providers’ clinical data for a broader set of users

Providers are increasingly conscious of the inherent value of their clinical practice data, but the vast majority of organizations lack the IT bandwidth and data management resources necessary to transform these assets in ways that can support clinical and operational research. Trusted third-party vendors specializing in data science can help these provider organizations optimize the data’s quality and potential use cases – both for themselves and for other ecosystem stakeholders.

Navigating the promise and peril of consumer data

Consumer data hold the potential to help in the development of products and programs to improve patient health. But any use of such data – whether by health plans, providers, health tech companies or life sciences manufacturers – raises a host of legal and privacy concerns. Companies interested in these resources must balance their potential with the operational, financial, equity and reputational risks.

Pushing beyond the biosimilar tipping point

This year is shaping up to be a seminal year for the U.S. biosimilar market. As more biosimilars become available, the focus may be less on payer coverage and adoption than on efforts to build patient and provider trust through education and evidence-generation that can reassure them about the value of their medication choices.

Building the case for more evidence to support “everywhere care”

While the continued shift of care to virtual, home and retail settings may lower episodic costs and increase consumer convenience, it is disrupting patient journeys and clinical information flows in potentially problematic ways. Life sciences companies should consider what may be missing in even their most robust real-world data (RWD) assets, while also making efforts to generate new evidence and expand patient-provider education in ways that can fill critical knowledge gaps.

Monitoring the ripple effects of the clinical workforce staffing crisis

Leaders of health care delivery organizations cannot achieve a sustainable workforce environment without structural and technological changes across clinical and nonclinical roles. Life sciences manufacturers may increasingly collaborate with digital health companies to find new ways to integrate evidence into clinical workflows to support providers and their staff.

To take a deeper dive into each of these trends, read this e-book which contains additional commentary and insights.