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Clinical Trial Excellence: Toolkit for Winning Investigators in a Competitive Marketplace

ID: OP-105


Features:

46 Info Graphics

15+ Narratives

36+ Best Practices


Pages: 73


Published: Pre-2014


Delivery Format: Shipped


 

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  • STUDY OVERVIEW
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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.


Industries Profiled:
Pharmaceutical; Medical Device; Biotech; Diagnostic


Companies Profiled:
ALTANA Pharmaceuticals; 3M Pharmaceuticals; Amersham Health; Amgen; AstraZeneca; Baxter Healthcare; Bristol-Myers Squibb; Eli Lilly; GlaxoSmithKline; Human Genome Sciences; Janssen Pharmaceuticals; Panacos Pharmaceuticals; PLIVA d.d.; Perlegen Sciences; Roche


Table of Contents

Toolkit for Winning Investigators in a Competitive Marketplace

Topic

INTRODUCTION

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