Best Practices in Study Feasibility

  • ID: 4226672
  • Report
  • Region: Global
  • 106 Pages
  • Industry Standard Research (ISR)
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One of the primary challenges to successfully completing a clinical study is estimating the medical, clinical, logistical, and regulatory feasibility of the trial. Within the clinical trial feasibility process, sponsors, CROs and sites evaluate the possibility of conducting a clinical trial within a specific geographic region with the overall objective of completing the project with targeted patients and within defined timelines and costs. Thorough feasibility analyses that implement best practices will assist sponsors in delivering successful site start-ups and trials with data from the right patients while finishing on-time and on-budget. Opinions were gathered from key stakeholders-sponsors, CROs and sites-to identify the best practices within the feasibility analysis process.

What You Will Learn:

  • The percentage of trials that require a feasibility analysis and whether the analysis is conducted in-house or outsourced
  • Objectives for conducting a feasibility analysis and the data sources utilized and site selection strategies
  • Awareness of feasibility analysis service providers, frequency of use and how well providers performed with respect to client expectations

How You Can Use This Report:

  • Implement the top techniques and innovations identified by sponsors and CROs for conducting a feasibility analysis
  • Improve the accuracy of your own feasibility analyses by learning which characteristics and activities contribute to predictive feasibility estimate
  • Understand the potential value to be gained by engaging a specialized feasibility analysis firm under specific circumstances
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1. Introduction

2. Methodology 

3. Facilitators & Barriers To Feasibility Analysis Success

  • Primary Findings
  • Objectives when conducting a feasibility analysis
  • Consistency of industry’s feasibility analysis process
  • Use of feasibility analysis SOPs
  • Feasibility analysis site selection strategies
  • Characteristics of a predictive or accurate feasibility estimate - unprompted
  • Tracking the accuracy of in-house feasibility estimates
  • Accuracy of feasibility estimates from CROs, sites, and specialized firms
    1. Sponsors
  • Improving feasibility estimates and analysis
  • Top techniques or innovations for feasibility analyses
  • Data sources for in-house feasibility analyses
    1. Sponsors
    2. CROs
    3. Sites
  • Preferred data sources when using a service provider for feasibility analysis
  • Sponsors

4. Specialized Feasibility Analysis Firms Market Overview 

  • Primary Findings
  • Circumstances for contracting a specialized feasibility firm - unprompted
    1. Sponsors
    2. CROs
  • Specialized feasibility firm differentiators -
  • unprompted
    1. Sponsors

5. Feasibility Analysis Service Provider Performance 

  • Primary Findings
  • Sponsors’ use of feasibility analyses
  • Awareness of feasibility analysis service providers
    1. Sponsors
    2. CROs
  • Feasibility analysis service provider use
    1. Sponsors
    2. CROs
  • Opinion of in-house feasibility analysis capabilities
  • Feasibility analysis service provider
  • performance
    1. Sponsors
    2. CROs

6. Study Data 

  • Feasibility analysis objectives
    1. Sponsors
    2. CROs
  • Characteristics of a predictive or accurate feasibility estimate - unprompted
    1. Sponsors
    2. CROs
    3. Sites
  • Consistency of industry’s feasibility analysis process
    1. Sponsors
    2. CROs
    3. Sites
  • SOPs for conducting a feasibility analysis
  • Tracking the accuracy of in-house feasibility estimates
  • Feasibility estimate accuracy
    1. Sponsors
  • Percentage of trials that require a feasibility analysis
    1. Sponsors
  • Use of outside service providers for feasibility analysis
    1. Sponsors
  • Conduct internal feasibility analysis when outsourcing
    1. Sponsors
  • Conduct internal feasibility analysis when using in-house development resources
    1. Sponsors
  • Data sources for in-house feasibility analysis
    1. Sponsors
    2. CROs
    3. Sites
  • Barriers to using EMR data for feasibility estimates - unprompted
    1. Sponsors
    2. CROs
    3. Sites
  • Preferred data sources when using a service provider for feasibility analysis
    1. Sponsors
  • Opinion of in-house feasibility analysis capabilities
    1. Sponsors
    2. CROs
    3. Sites
  • Utilization of investigators or coordinators when developing protocols
    1. Sponsors
    2. CROs
  • Site selection strategy for feasibility analysis
    1. Sponsors
    2. CROs
  • Pre-determined site criteria - unprompted
    1. Sponsors
    2. CROs
  • Ranking data sources’ impact on accuracy
    1. Sponsors
    2. CROs
    3. Sites
  • Circumstances for contracting a specialized feasibility firm - unprompted
    1. Sponsors
    2. CROs
  • Specialized feasibility firm differentiators - unprompted
    1. Sponsors
    2. CROs
  • Room for improvement in CRO and sponsor feasibility processes
    1. Sites
  • Characteristics of different and more effective feasibility processes - unprompted
    1. Sponsors
    2. CROs
    3. Sites
  • Feasibility estimate challenges
    1. Sponsors
    2. CROs
    3. Sites
  • Challenges impact on feasibility estimate accuracy in ranked order
    1. Sponsors
    2. CROs
    3. Sites
  • Confidence in feasibility estimates
    1. Sponsors
    2. CROs
    3. Sites
  • Desired improvements to feasibility estimates - unprompted
    1. Sites
  • Best techniques and innovations for feasibility analysis - unprompted
    1. Sponsors
    2. CROs
  • Awareness of service providers’ feasibility analysis capabilities
    1. Sponsors
    2. CROs
  • Feasibility analysis service provider use
    1. Sponsors
    2. CROs
  • Feasibility analysis service provider performance
    1. Sponsors
    2. CROs

7. Respondent Profile 

  • Organization Type
  • Responsibilities
  • Interaction with functions
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