• 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 » Article: Access to full trial data sets benefits industry

Article: Access to full trial data sets benefits industry

October 25, 2013
CenterWatch Staff

Access to full data sets from clinical trials will benefit both large and small biopharmaceutical companies and researchers, according to an article published in the New England Journal of Medicine by four members of the EMA staff, including its executive director and senior medical officer. 

“A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders,” said the authors.

In Access to patient-level trial data—A boon to drug developers, the authors argued access to complete clinical trial data, including patient-level data, will achieve the following:

  • Help increase the efficiency of drug development and improve cost effectiveness. Access to full data sets of completed studies will lead to improvements in the design and analysis of subsequent trials for which patient selection criteria will have been refined. Lessons learned from past trials about the heterogeneity of treatment effects will not only streamline drug development, but also may enhance the value of a medicine in the marketplace by allowing the identification of patient populations with a high unmet need where the new medicine may be more cost-effective than other available treatment options.
  • Improve comparative-effectiveness analysis. Wider access to patient-level data will allow sponsors to present more robust comparative-effectiveness information about their product soon after licensing and at limited cost compared with head-to-head trials, which is essential information during reimbursement negotiations with payers.
  • Reduce duplication of effort among trial sponsors. One of the inherent inefficiencies of data secrecy is the repetition of unsuccessful trials and projects that cost millions and unnecessarily expose patients in trials to potential risks.

In response to concerns related to the risk of misinterpretation of clinical trials, the authors said inappropriate secondary data analyses are likely to occur regardless of the nature of the data. To address this risk, they call for a two-way transparency principle by which any secondary analysis is also to be published and subject to critical review.

The EMA recently published a draft policy on publication and access to clinical trial data, including patient-level data. The agency currently is reviewing the comments received on the draft policy as part of the three-month public consultation phase that ended Sept. 30.

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