REAL-WORLD EVIDENCE

Real-world evidence (RWE) – the concept of using real-world data (RWD) to improve clinical evidence – has the potential to transform the drug development landscape. The Food and Drug Administration (FDA) recognizes the opportunities presented by RWE and has taken steps to develop a new paradigm for its use in regulatory decision-making.

Greenleaf’s exclusive agreement with Trio Health, a leading provider of real-time data on real-world patients, gives clients the advantage of Trio’s groundbreaking Multi-Disease Platform (MDX) technology integrated with Greenleaf’s unrivaled regulatory knowledge. The result is a comprehensive resource for enhancing and contextualizing evidence derived from RWE.

THE MDX PLATFORM

The first-of-its-kind MDX platform tracks patients throughout the course of their treatment by combining disparate information from the physician, pharmacy, and payer ‘trio.’ MDX offers life science customers best-in-class speed, data certainty, and unparalleled visibility across the clinical and commercial lifecycle. Trio’s comprehensive and high-quality databases are on caliber with FDA-level rigor, giving pharmaceutical and biotechnology companies, specialty pharmacies, and physicians access to information and opportunities that can be leveraged to support pre- and postmarketing activities.

When integrated with Greenleaf’s regulatory expertise, Trio’s advanced analytics MDX platform delivers unrivaled insights to the industry. In particular, clients gain the ability to transform real-world data into actionable intelligence to innovate and make better decisions, with greater confidence, throughout the product lifecycle. Greenleaf’s team of regulatory experts provides end-to-end guidance to companies utilizing MDX data on how to optimize and validate the information to drive effective regulatory strategies.

RWE + FDA

RWE has the potential to accelerate the development of new treatments, provide physicians with unmatched insights, support coverage decisions, and optimize patient care. As such, RWE is playing an increasing role in FDA decision-making.

In December 2018, the FDA released a draft framework for its RWE Program. The FDA framework is intended to “guide generation of data in support of approval for new indications or to help support post-approval study requirements.” The framework outlines the scope of the FDA’s RWE Program and begins by defining RWE as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).”

Since publishing the draft framework, the FDA has published guidance for industry regarding “Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics” and “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.”

Greenleaf’s team of regulatory experts — specializing in drug and biological products; medical devices and combination products; and product quality, manufacturing, and compliance — provides unmatched insight and consultation on all aspects of the FDA’s regulatory application of RWE. The combined achievements and substantial qualifications of the full Greenleaf team enable a cross-functional, full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges.

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Real-World Evidence Team Members