Clinical Trial Excellence

Summary

Market competition is mounting to win the time, attention and interest of the most qualified clinical investigators. Field research shows that the most sought-after clinical investigation sites turn down 60-70% of the clinical trial invitations that they receive at their labs and clinics. Consequently, leading pharmaceutical companies are seeking better ways to manage the art and science of investigator recruitment.

Best Practices, LLC's new toolkit integrates best practices in winning clinical investigators in a competitive marketplace into an easy-to-follow format. This toolkit is designed to aid managers in their efforts to identify, select and recruit top investigators in their therapeutic areas. The toolkit draws from interviews and surveys and executives at 15 pharmaceutical companies and 7 Contract Research Organizations/Site Management Organizations. It also includes insights gathered from interviews and surveys with a cross section of 20 investigators and investigative site staff members.

Contents

• Introduction
  • Figure I.1 - Investigator Recruitment Cycle
  • Figure I.2 - Investigator Development Process
  • Figure I.3 - Benchmark Class
  • Plan: Seeding Your Long-Term Success
  • Key Skills: Building A Winning Team
  • Skills Necessary for Identifying Investigators
  • Skills Necessary for Recruiting Investigators
  • Segmenting Investigators
  • Understanding Motivators
  • Linking Motivations to Site Characteristics
  • Developing Relationship Plans for Investigators
  • Using Science to Motivate Investigators
  • Protocol Design
  • How Many Investigators to Include
  • Figure 1.1 - Investigators in Protocol Design
  • Methods for Soliciting Support
  • Ensuring The Protocol Is Practical
  • Identification Process
  • Gather Names from Existing Databases
  • Solicit Input from Internal Groups
  • Examine External Data Sources for Names
  • Figure 1.2 - Literature Searches
  • Figure 1.3 - Fda Filings
  • Develop and/or Consult External Contacts
  • Publicize The Study Opportunity
  • Working with Cros
• Screen: Building Systems to Select The Best
  • Selection Process
  • Who Should Be Involved in Selection
  • Develop and Ideal Patient Profile
  • Employ Epidemiological Data to Find Investigators
  • Develop High-Performer Profiles
  • Factors to Include in Selection
  • How to Measure past Performance
  • Develop Non-Traditional Site Selection Criteria
  • Feasibility Surveys
  • Maximizing The Site Visit
  • in-Person Site Visit Criteria
  • Emphasize Protocol
  • Quantify Questions beyond ""yes or No""
  • Figure 2.1 - Move beyond 'yes or No'
  • Target Motivated Physicians Who Are Most Likely to Deliver
  • on Patient Enrollment Goals
  • Evaluate The Investigator's Referral Structure
  • Evaluate The Site's Study Nurse
  • Employ Portfolio Management Practices
• Execute: Getting Things Done in The Field
  • Create A Training Decision Process
  • Working with Site Coordinators
  • Recognizing The Site as Value Creator
  • Assist Investigators with Patient Recruitment
  • Use Investigator Satisfaction Surveys
  • Database & Website Integration: Developing A
• Continuous Source of High-Quality Investigators
  • Building A Best-in-Class Database
  • Figure 4.1 - Database Process Map
  • Methods for Investigators to Self Identify
  • Proactive Identification via The Internet
  • Figure 4.2 - Clinical Trial Website Example
  • Figure 4.3 - Clinical Trial Website Example
  • Organize Database for Optimal Continuous Efficiency & Effectiveness