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

STUDY OVERVIEW

Intervention Studies, which in this research encompass three 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 three study methods (Expanded Access Programs, Randomized Pragmatic Trials, Other Low-Intervention Clinical Trials (not including Randomized Pragmatic Trials)). In addition, the study presents benchmarks on the data collection methods used, the level of outsourcing used and valued vendor traits for these three study types.

KEY TOPICS

• Executive Summary: Methodology, Participants, & Key Findings
• Overview of Intervention Studies Utilization, Data Collection Methods & Outsourcing
• Intervention Studies: Expanded Access Programs, Randomized Pragmatic Trials, Other Low-Intervention Clinical Trials (not including Randomized Pragmatic Trials)

KEY METRICS

• Note: The questions below were asked for each of the 3 types of Intervention Studies examined in this study
• What is your level of awareness/utilization regarding Intervention Studies?
• Do you believe your usage of Intervention Studies will increase/decrease/stay same?
• How many Intervention Studies did you conduct in the past year?
• In 2020, how many Intervention Studies do you anticipate doing?
• What methods of data collection do you use for Intervention Studies?
• In 2020, what methods of data collection will you use for Intervention Studies?
• To what extent do you outsource Intervention Studies?
• For Intervention Studies, what is the most critical characteristic you desire in a vendor?
• If you have a preferred vendor for Intervention Studies, please identify them

SAMPLE KEY FINDINGS

• Intervention Studies: Most respondents use a mix of in-house & outsourcing for 2 of 3 studies in this category: The two studies in this category where most use a mix of in-house and outsourcing were: Randomized Pragmatic Trials and Other Low-intervention Clinical Trials. Expanded Access Programs, meanwhile, was the lone study type to use mainly in-house.

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

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