• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Drug Industry Comments on FDA’s Real-World Evidence Program

Drug Industry Comments on FDA’s Real-World Evidence Program

February 18, 2019
William Myers

Drug sponsors are eager for the FDA to embrace real-world evidence (RWE), but several companies are asking the agency to clarify how it can be used in clinical trials.

Late last year, the FDA invited public comments on a plan for its real-world evidence framework, and it received 30 overall, nine from drugmakers.

One of the major threads in the comments was about data: specifically connectivity, gaps and capture. The framework “does not provide clarity regarding the kinds of data standards required, who is responsible for developing data standards or the process by which FDA will assesses the acceptability of those standards,” Janssen wrote. “Will FDA require different data standards for different data sources (e.g., health insurance claims vs. electronic health records) or for different types of regulatory decisions?”

Another thread was about evidentiary standards and adequate scientific evidence. “There is not enough detail for sponsors to know whether their evidence will satisfy these criteria. We realize that the practice of using RWE for regulatory decision-making outside of addressing safety questions is still in its infancy,” Janssen added.

Some sponsors also latched on to language that suggested the agency might be open to using observational studies that “replicate” randomized trial results and were worried that the word is a little too vague. Sanofi, for instance, urged the FDA to declare that observational studies can be used “to elucidate the degree of consistency” between randomized control trials and observational studies.

Janssen, too, said it had many questions about replicating randomized trials — how will the agency determine how feasible replication is, and which trials would be subject to replication? How will regulators deal with “confounding” studies? Does the agency have metrics for how well randomized trials and real-world evidence line up?

Novartis also suggested that sponsors should be more prominent in the demonstration projects that the FDA is developing. The company commented on the “clear lack of industry (i.e., drug sponsors) participation” in those projects.

Regeneron suggested that the FDA “provide some discussion points to assist sponsors in how best to apply practices or lessons learned from these programs to planned or future studies to assist in regulatory decision-making, particularly in areas of high unmet medical need.”

Novo Nordisk said it would like to see examples of adaptive or Bayesian trial designs, which the FDA has said might help qualify biomarkers for trials. The agency should also be open to using preclinical data for biomarkers, Novo said.

Read the comments here: https://bit.ly/2DKS7s7.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing