• 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
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Report: Real-world evidence use in clinical & post-approval research set to expand

Report: Real-world evidence use in clinical & post-approval research set to expand

November 10, 2017
CenterWatch Staff

Real-world evidence is poised to play a growing role in drug development during the next three years, but the availability and cost of acquiring data remain key challenges, according to a recently completed study conducted by the Tufts Center for the Study of Drug Development.

Large pharmaceutical, biotechnology and CROs plan to increase internal staff dedicated to collection and analysis of real world data by 25% between now and 2020, according to a survey conducted by Tufts CSDD.

"Drug developers are utilizing real-world evidence across a number of areas, including assessing the economic value of products, gaining insight into drug safety and effectiveness, and evaluating quality of life outcomes," said Mary Jo Lamberti, Ph.D., senior research fellow at Tufts CSDD and lead investigator on the study. "While the cost and effort to integrate data sources, and then convincing regulators and payers of the validity of that evidence, pose hurdles to expanded use of real-world evidence, developers are confident that emerging technologies will help them address those issues."

Real-world evidence (RWE) is data collected from sources outside of randomized controlled clinical trials and can include data from electronic health information, social media and mobile and wearable devices.

Study results were reported in the November/December Tufts CSDD Impact Report. The study also found that:

  • Commercial functions within drug development organizations are the primary users of RWE today, although 40% of R&D operations rely on it.
  • Social media data is projected to be used by 42% more companies in 2020, compared to 2017, whereas fewer companies expect to be using claims and prescription data in three years.
  • 60% of respondents said availability of data poses the greatest challenge in utilizing RWE, followed by lack of external stakeholder trust in RWE, cost of acquiring data, cost and effort of data integration, determining causation, and quality and reliability of claims and electronic health record data.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

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

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

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 © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing