• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • 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 » Regulatory requirements become more complex as clinical trials increase

Regulatory requirements become more complex as clinical trials increase

August 12, 2011
CenterWatch Staff

As pharmaceutical and biopharmaceutical companies increase the number of clinical trials they conduct in emerging global markets, growing regulatory complexity is forcing them to change the way they operate, experts have warned, according to PharmaTimes.

"What a company does in one region can very likely affect how regulators treat it elsewhere," according to Christopher-Paul Milne, associate director of the Center for the Study of Drug Development (CSDD) at Tufts University, Boston, Massachusetts.

"Understanding local regulatory requirements and trends, and how competitors' activities are shaping those trends, has become a minimum requirement for engaging in global drug development," he says, commenting on the findings of the Tufts CSDD executive forum round table, a panel of leaders from the research-based pharmaceutical industry convened recently by the center.

Flexibility may be the decisive success factor when it comes to drug development strategy, according to Mr. Milne. "What's true today in the regulatory environment in a particular region may not hold sway when trials are completed in a few years' time, requiring a rapid shift in development strategy," he says.

The number of pre-clinical and clinical studies in process around the world grew rapidly during the last decade - from approximately 4,900 in 2000 to 8,600 in 2010, according to Tufts CSDD. This fast growth has, in turn, put pressure on regulatory authorities to keep up with additional demands relating to monitoring studies and reviewing results.

The panel also found that this advancing regulatory complexity is generating increased amounts of data, which requires drug developers to improve the way they manage their information. Moreover, the success of regulatory affairs groups within drug development companies will depend on their ability to understand and respond, on a global basis, to the sometimes-conflicting requirements of regulatory agencies and authorities.

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    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

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    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