• 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
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » COVID-19 Trial Disruptions Total More Than 1,100, Study Shows

COVID-19 Trial Disruptions Total More Than 1,100, Study Shows

COVID19Disruption-360x240.png
May 18, 2020
Leslie Ramsey

COVID-19 has caused nearly half of all trial disruptions in the past five months, with oncology trials being hardest-hit, according to a new study out of Berlin.

Forty-four percent of the more than 2,600 clinical trials stopped in the past five months for any reason have cited the COVID-19 outbreak as the cause, the ongoing study shows.

More than 1,100 trials have been impacted by COVID-19 since December with 97 percent suspended, 2 percent terminated and 1 percent withdrawn, according to a study of 90,000 trials that seeks to analyze the effect of the pandemic on sponsors, research sites and patients.

Of all therapeutic areas, oncology trials are bearing the brunt of the crisis with 28 percent of studies affected, followed by cardiovascular at 11 percent, neurologic at 8.5 percent and pain management at 5.2 percent, the study from Benjamin Carlisle of university hospital Charité in Berlin shows.

Trials disrupted by COVID-19 involve nearly 40,000 already-enrolled patients and 4 million more planned enrollees. Most of the trials — 84 percent — are interventional and 15 percent are observational.

Reasons listed for suspending trials include such statements as “Healthy volunteer enrollment on hold at site due to COVID-19 pandemic,” “Coronavirus stay-at-home orders prevent in-person data collection” and “Study halted prematurely due to COVID-19 but potentially will resume. Follow-up visits continue virtually.”

Studies terminated/withdrawn cite such reasons as loss of funding, disruption of research team, cessation of nonessential clinical activities, recruiting problems and small numbers of new participants enrolled.

While most sponsors and sites intend to revive their trials, says Carlisle, the future doesn’t look promising. “The prospect of starting again is far from certain for any clinical trial that has stopped, and even in cases where a clinical trial resumes after the pandemic, there may be reduced statistical power, more funding needed or changes to the protocol to accommodate for the interruption,” Carlisle says.

Carlisle is gathering data from trials listed on ClinicalTrials.gov to assess the nature of COVID-19 disruptions and hopefully provide some insight into when recovery could occur. Examining data on the nearly 1,300 trials suspended in the same five-month period two years ago, he found only 9.5 percent of them were restarted within one year.

Carlisle is updating the numbers daily as the pandemic continues. He plans to continue collecting data until there has been a two-week period without a COVID-19 trial disruption or on Nov. 30, whichever comes first.

To view study data and the current report, click here: https://bit.ly/2WWus1F.

COVID-19
  • Related Directories

    Olumiant (baricitinib)

    Veklury (remdesivir)

    Comirnaty (COVID-19 Vaccine, mRNA)

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

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

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

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 or Share My Data

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing