LS&HC Horizons 2022 - Flipbook - Page 69
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
69
United States
Real-World Evidence regulatory considerations in the United States
Advances in the availability and sophistication of real-world data
(RWD) and real-world evidence (RWE) have led to an increased
interest in a role for RWE in medical product development and FDA
regulatory decisions. FDA has placed increasing emphasis in recent
years on the use of RWE in regulatory decision-making, but questions
remain as to whether the policies set out in FDA’s recent guidances are
a significant step forward.
RWD/RWE can enable more efficient and timely development of
evidence that support regulatory decision-making, including where
traditional randomized clinical trials (RCTs) are impractical (e.g., rare
diseases) and where there are evidentiary gaps not easily addressed
with traditional RCTs (e.g., patients with multiple comorbidities,
patient experience, long-term outcomes). FDA’s guidances
reflect a formal willingness to evaluate RWE that meet regulatory
standards. However, the Agency has not yet fully addressed complex
considerations around the quality and reliability of the data and
statistical methods that are critical to permit inferences regarding the
safety and effectiveness of a medical product for a particular disease
or condition. Until more meaningful guidance is developed, early and
detailed discussions with FDA can help determine the extent RWD/
RWE could be utilized for a particular purpose.
We expect FDA to prioritize additional RWD/RWE regulatory policies
and systems to provide sponsors with greater confidence around the
use of RWD/RWE that meet scientific and regulatory standards. We
leverage our deep understanding of product development, clinical
trial design, and data standards to guide our life sciences and digital
technology clients through challenging regulatory issues and will
continue to closely track FDA’s evolving RWD/RWE paradigm.
Lynn Mehler
Partner, Washington, D.C.
Lowell Zeta
Partner, Washington, D.C.
Kristin Zielinski Duggan
Partner, Washington, D.C.
Sally Gu
Associate, Washington, D.C.
