• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • 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
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Leading researchers outline principles for conduct of comparative effectiveness research

Leading researchers outline principles for conduct of comparative effectiveness research

September 12, 2012
CenterWatch Staff

A new set of principles developed by a group of leading researchers could help to ensure more consistency in how comparative effectiveness research (CER) is planned and conducted. These guiding principles were published in the September issue of The Journal of Comparative Effectiveness Research.

“These are voluntary principles that can help to improve the quality of CER, which in turn can help patients and providers make better treatment decisions,” said Bryan R. Luce, PhD, MBA, United BioSource and the University of Washington, and one of the researchers who developed the guidelines. “For CER to succeed in guiding health decisions, it should be planned and conducted with rigor and transparency.”

To arrive at these best research practice principles, the researchers examined existing health technology assessment principles and engaged multiple CER experts and stakeholders for feedback.

The resulting 13 principles include ensuring that research objectives are clear, being transparent in how the research is conducted, involving stakeholders, including especially relevant decision makers, in a meaningful way throughout the research process, considering perspectives and interests from a wide range of stakeholders, using relevant comparators, and evaluating relevant outcomes and the impact of individual treatment effects on patients. The researchers acknowledge that “no one study will necessarily be able to fully meet every principle to the letter,” but that CER should always endeavor to fulfill, and never ignore, their intent.

“Going forward, it will be important to evaluate how well CER studies adhere to these principles. We can then determine whether CER studies that use those principles are having an impact on patient care or are being appropriately adopted into guidelines and clinical practice,” said Robert W. Dubois, MD, PhD, National Pharmaceutical Council, and one of the researchers who developed the guidelines.

The principles and paper were developed by Luce; Dubois; Michael F. Drummond, PhD, University of York; Peter J. Neumann, ScD, Tufts Medical Center and Tufts University School of Medicine; Bengt Jönsson, PhD, Stockholm School of Economics (Sweden); Uwe Siebert, MD, MPH, MSc, ScD, University of Health Sciences, Medical Informatics and Technology (Austria) and Harvard School of Public Health; and J. Sanford Schwartz, MD, Wharton School of Business and Perelman School of Medicine, University of Pennsylvania.

Upcoming Events

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 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

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

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