• 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 » DIA Annual Meeting: Most FDA Expert Reviewers See Data Quality Lapses in Applications

DIA Annual Meeting: Most FDA Expert Reviewers See Data Quality Lapses in Applications

June 22, 2020

A significant percentage of new drug and biologics applications are tripped up by “system-wide” data quality problems, an agency survey of FDA expert reviewers found.

More than two-thirds of the FDA expert reviewers who assess new drug applications (NDAs) and biologics license applications (BLAs) said they encountered data quality problems during the assessments, although only 15 percent led to site inspections or complete response letters, according to the survey.

The survey, unveiled at the Drug Information Association’s global annual meeting, found that the data quality issues frequently led to agency requests for more information.

Half of the survey’s 95 respondents reported issues related to data management and/or programming; 45 percent cited problems with data collection, such as poorly designed case report forms; and 35 percent ran into issues with study conduct, such as protocol adherence and problems with drug accountability and compliance.

“Data quality issues vary, but data management, report structure and study conduct are the most frequent issues,” said Vaishali Popat, an associate director for biomedical informatics in the FDA’s Office of New Drugs (OND).

In the survey, 25 percent reported data traceability issues; 20 percent cited missing safety data; 20 percent found incompatible data outliers, such as males with pregnancy or ages over 150; and 35 percent noted that they saw “other issues” with data quality in their reviews.

The “key takeaway,” Popat said, was that 40 percent ran into “system-wide issues,” such as poor electronic systems and database management and a lack of corrective and preventive action programs.

Additionally, 25 percent of reviewers found data had possibly been misrepresented, while 20 percent found site-related issues, such as no adverse events and perfect efficacy reported at sites with high enrollment.

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