Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.”  This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post.

According to the Federal Register notice, the public workshop is being convened by Duke University’s Robert J. Margolis, MD, Center for Health Policy (Duke Margolis) and supported by a cooperative agreement with FDA.  The workshop will cover considerations for using randomized clinical trial designs and real-world data (RWD) to generate RWE, including the following –

  • the selection of interventions appropriate in clinical care settings;
  • study design elements and study populations;
  • capturing outcomes in clinical care settings;
  • addressing potential challenges around blinding, randomization, and bias; and
  • regulatory considerations for randomized clinical trials using RWD (e.g., safety and product monitoring and maintaining data integrity).

This public workshop will follow on the heels of a meeting held by the Department of Health and Human Services (HHS) to “seek public input and comment on opportunities to leverage departmental resources, increase collaboration, and to partner with private stakeholders in the service of accelerating the process for clinical innovation in the United States.”  The HHS meeting also was announced recently in the Federal Register and will take place on June 20-21.

Photo of Mingham Ji Mingham Ji

Mingham Ji is an associate in the firm’s Washington, DC office, where she is a member of the Food and Drug and Anti-Corruption practice groups. Ms. Ji advises food, dietary supplement, pharmaceutical, and biotechnology companies on regulatory and compliance issues.

Photo of Wade Ackerman Wade Ackerman

Through more than a decade of experience in private practice and positions within the FDA and on the Hill, Wade Ackerman has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. Mr. Ackerman advises clients on FDA…

Through more than a decade of experience in private practice and positions within the FDA and on the Hill, Wade Ackerman has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. Mr. Ackerman advises clients on FDA regulatory matters across a range of sectors, including drugs and biologics, cosmetics, medical devices and diagnostics, and digital health products and services associated with drugs and traditional devices. He serves as one of the leaders of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and marketing of digital health technologies.

Photo of Krista Carver Krista Carver

Krista Hessler Carver advises medical device, biotechnology, pharmaceutical and cosmetic manufacturers and trade associations on a wide range of FDA regulatory, compliance, transactional, and legislative matters. Ms. Carver has particular experience with legal and regulatory issues related to biosimilars, medical devices, combination products…

Krista Hessler Carver advises medical device, biotechnology, pharmaceutical and cosmetic manufacturers and trade associations on a wide range of FDA regulatory, compliance, transactional, and legislative matters. Ms. Carver has particular experience with legal and regulatory issues related to biosimilars, medical devices, combination products, and personalized medicine.