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Products & Services Medical Affairs Data Management and Biostatics

Understanding the Changing Landscape of Real World Evidence Generation: Extension Studies

ID: 5527


Features:

6 Info Graphics

17 Data Graphics

70 Metrics


Pages/Slides: 29


Published: 2018


Delivery Format: Online PDF Document


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "Understanding the Changing Landscape of Real World Evidence Generation: Extension Studies"

STUDY OVERVIEW


Real World Evidence (RWE) is a key driver of formulary and reimbursement decisions by both public and private payers and is an important focus area for global regulators. Consequently, the pharmaceutical industry has been boosting internal RWE capabilities and is increasingly outsourcing to vendors specializing in RWE generation.

Extension Studies, which in this research encompass two RWE study methods, are sometimes utilized by pharma companies. Best Practices, LLC conducted this study to gain insights into current and future utilization of these two study methods (Concurrent Outcomes Studies and Extension Studies). In addition, the study presents benchmarks on the data collection methods used, the level of outsourcing used and valued vendor traits for these two study types.

KEY TOPICS

  • Executive Summary: Methodology, Participants, & Key Findings
  • Overview of Extension Studies Utilization, Data Collection Methods & Outsourcing
  • Extension Studies: Concurrent Outcomes Studies and Extension Studies

KEY METRICS

  • Note: The questions below were asked for each of the 2 types of Extension Studies examined in this study
  • What is your level of awareness/utilization regarding Extension Studies?
  • Do you believe your usage of Extension Studies will increase/decrease/stay same?
  • How many Extension Studies did you conduct in the past year?
  • In 2020, how many Extension Studies do you anticipate doing?
  • What methods of data collection do you use for Extension Studies?
  • In 2020, what methods of data collection will you use for Extension Studies?
  • To what extent do you outsource Extension Studies?
  • For Extension Studies, what is the most critical characteristic you desire in a vendor?
  • If you have a preferred vendor for Extension Studies, please identify them

SAMPLE KEY FINDINGS

  • Extension Studies: This study method is only used by 17% of respondents, 67% of whom say their future utilization will remain the same. Meanwhile 59% of the respondents currently not using it say they will utilize it in the future.

METHODOLOGY

This study engaged 25 leaders within 19 global organizations with deep experience in managing Real World Evidence generation at top pharmaceutical companies.

Industries Profiled:
Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Health Care; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
Bayer; Flexion; Vifor Pharma; Dermira; AstraZeneca; Janssen; EMD Serono; Grifols; GlaxoSmithKline ; Abbott; Novartis; Abbvie; Genzyme; Merck; UCB Pharma; Sanofi; Celldex Therapeutics

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.