• 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
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Bert Spilker's Pharma Principles of The Week

Bert Spilker's Pharma Principles of The Week

February 2, 2007
CenterWatch Staff

Posted Bert Spilker

  • Work hard to avoid protocol amendments as they consume a great deal more resource than one imagines in staff time to prepare, review and implement them. Some vendors have systems to minimize the numbers of amendments a company will need, by subjecting protocols to multiple internal checks of consistency, and comparisons with other protocols that have been conducted.
  • The number of patients available to join a trial drops by about 90% the day a trial begins. This is referred to as “Lasagna’s Law” and is mitigated by using only inclusion criteria that are truly required and by reviewing potential enrollees prior to choosing the site investigators.
  • Locate world class experts through professional associations, trade associations, local experts who can tell you the world’s top people in his area, FDA reviewing divisions, FDA Advisory Committee members, other companies in the therapeutic area, and/or literature citations of those quoted most often.

Bert Spilker , PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of  Bert Spilker & Associates (BS&A).

 

Upcoming Events

  • 26Jan

    Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

  • 27Jan

    Medical Device Clinical Trials in China: Latest Regulatory Developments

  • 11Feb

    Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • Virtual Doctoer

    Simple Changes Can Make Trials More Patient Friendly

  • Drug approval

    Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S.

  • VaccinewithNeedle-360x240.png

    Rules of Vaccine Approval May Be Changing, But Statistical Analysis Tools Remain Constant

  • AskTheExperts-360x240.png

    Ask the Experts: Trial Operations Adjustments in a Remote World

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 © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing