• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Study: 60% of protocols amended during clinical trials

Study: 60% of protocols amended during clinical trials

September 14, 2011
CenterWatch Staff

Nearly 60% of all protocols used in clinical trials for new drugs are amended during the study, but one-third of those changes could have been avoided, according to a new study, reported by PharmaTimes.

Completed protocols across all clinical trials incur an average of 2.3 amendments, with each requiring an average of 6.9 changes to the protocol, and this leads to significant unplanned expense and delay, says the study, which was conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) in order to quantify the impact of protocol changes on clinical trials.

"Although amendments to protocols of clinical trials are sometimes necessary to optimize study results and ensure patient safety and ethical treatment, study sponsors can minimize the number of protocols through better initial study design and improved recruitment of study volunteers," commented Ken Getz, owner of CenterWatch, who carried out the study. Getz is a senior research fellow at Tufts CSDD and assistant professor at Tufts University.

He forecasts that a high incidence of protocol amendments is likely to continue, given the analysis' finding that the mean number of amendments was positively and significantly correlated with the rising number of procedures per protocol, study length and number of investigative sites participating in each clinical trial.

The study also found that across all phases of clinical trials, 43% of protocol amendments occur before first patients are enrolled, with amendments more likely to occur in phase I studies. More than half of all protocols require one or more amendments, with phase III studies requiring the highest number of changes per amendment, at 8.5. One-third of all amendments relate to protocol description and patient eligibility criteria and the median total cycle time to identify and resolve a protocol problem is 61 days.

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

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

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    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 703.538.7600 – Toll free 888.838.5578

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