Clinical Trial Excellence: The Science & Art of Winning Investigators in a Competitive Marketplace

Industries Profiled:
Biotech; Pharmaceutical; Research; Medical Device; Diagnostic; Health Care; Professional Services


Companies Profiled:
Amersham; Sanofi-aventis; ALTANA Pharmaceuticals; Amgen; AAI Development; AstraZeneca; Biologicals International; ICON; Baxter Healthcare; Parexel; Bristol-Myers Squibb; Panacos Pharmaceuticals; Eli Lilly and Company; Perlegen Sciences; GlaxoSmithKline; PPD Development; Human Genome Sciences; Janssen; PLIVA Pharmaceuticals; Pfizer; Roche; 3M Pharmaceuticals; America's Doctor; BBK Healthcare; Covance; PPD

Study Snapshot

With a rise in competition for the time and attention of clinical investigators, pharmaceutical companies and clinical research organizations are particularly motivated to learn the science and art of winning the support of clinical investigators who will deliver patients to their studies and add credibility to their developing products. Delays in recruiting qualified investigators or in working with investigators who fail to produce their target number of patients can significantly cost pharmaceutical companies in lost product sales.

This comprehensive report provides clinical operations staff with specific examples, more than 180 metrics, and recommendations on how to identify and close performance gaps with respect to not only performance metrics but also processes and best practices. Critical improvement areas include investigator selection criteria, time to identify, select and recruit investigators, investigator input to protocol design, and valued investigator services. The ultimate goal of these efforts is to refine the working relationship with investigators to simultaneously improve their commitment to delivering patients to the trial, producing quality data and being an advocate for the developing product.

Armed with the expertise and lessons learned of 18 pharma and biotechnology companies, seven CROs and 20 clinical investigator sites, readers of this study will be able to forge more effective and profitable relationships with those who drive the clinical development process -- investigators.

Key Findings

Best Practices, LLC analysts identified several areas which distinguish high-performing clinical operations units and in which pharmaceutical companies and CROs can realize substantial gains. Below are three short versions of high-level findings from the report's executive summary; more granular practices with specific examples are contained within the report itself.

Align structures, teams and communication systems to ensure clear accountability internally and maximum impact externally with investigators.

Companies that effectively and efficiently recruit investigators have structures in place to support this effort. These companies align incentives and responsibilities to ensure one or more employees are directly accountable for successful investigator recruitment. Companies then empower those accountable employees to make the decisions necessary to deliver on investigator – and subsequently patient – recruitment goals. However, successful companies also understand the need to balance clinical operations requirements for investigators against those of other internal stakeholders.

Develop plans, targets and databases before the trial begins to ensure rapid investigator recruitment.

Successful companies understand that the process of recruiting investigators to participate in clinical trials must not be tied to any one trial – it must be an ongoing aspect of clinical operations. These companies plan proactively for clinical trials that still are months or even years in the future. Benchmark data shows that the majority of companies surveyed (80 percent) begin the process of identifying and recruiting investigators at least four months before the start of any clinical trial. Furthermore, as companies plan for specific trials, they create recruitment strategies, set goals and fully leverage internal resources to speed the process. 

Standardize process approaches to ensure quality and impact of work with CROs, partners and investigators.

Veteran clinical operations executives identified a common productivity frontier: developing well-defined work activities – i.e. process excellence – across clinical projects, studies, teams and therapeutic areas. The essence of their insight lies in this paradox: clinical trials tend to be organized as large but discrete projects. By their very nature, projects are often characterized by low-volume activities that are not repeated frequently. Consequently, such work processes are not articulated for high impact or high productivity. Yet, study sponsors continue to carry out these activities across scores of projects and programs; unfortunately, they often fail to benefit from process-oriented continuous improvement and standards of excellence across projects.

Project Focus 2

Key Findings 4

Report Structure and Organization 10

Path Forward 11

Best Practices Chapters

Chapter 1: Making Studies Attractive to Preferred Investigators 13

Using Relationship Management Strategies to Win the Hearts and Minds of Investigators 17

Using Protocol Involvement & Study Design to Solidify Investigator Support 31

Services and Training that Foster Loyalty 37

Chapter 2: Efficiently Identifying the Investigator Pool 45

Investigator Databases: Building a CRM Asset that Serves as Your Compass to Success 46

Finding New Investigators 54

Growing Your Own Investigators 62

Chapter 3: Selecting High Quality Investigators for a Study 66

Planning for Investigator Selection 69

Setting the Selection Criteria 73

Optimizing the Pre-Study Site Assessment 81

Chapter 4: Managing for Successful Investigator Recruitment 89

Managing the Pareto Effects and Performance Structures 91

Structures that Support Excellence 93

Roles and Responsibilities that Support Excellence 95

Using Therapeutic Structures to Nurture Expertise 99

The Role of Clear Communications in Execution Excellence 102

Goal Setting and Performance Management 105

Chapter 5: Working Effectively with Third-Party Providers 111

Overview 112

Leveraging External Expertise 113

Making the Best of the CROs 116

Findings in Brief

Lessons Learned: Pharmaceutical Companies & CROs 126

Lessons Learned: Investigators 128

List of Charts

Investigator’s Study Motivation
Motivation for Choosing Studies
Investigators: Building Credibility
Cornerstones for Credibility
Relationship Plans for Investigators
Customer Service for Investigators
Recruitment Customization
Focus on Science
Aspects of a Well-Run Trial
Investigators in Protocol Design
Protocol Reviews
Protocol Engagements
Investigator’s Preferences for Protocol Design Approaches
Approaches for Protocol Design
Top Three Factors for Choosing Trials
Services Investigators Value
Investigator Services
Study Payment Milestones
Payment Factors
Valued Recruitment Support
Patient Recruitment Services
Harnessing the Internet to Grow Sites
Efficient and Effective Databases
Identifying: Groups Often Involved
Identifying: Primary Responsibility
Identifying: Necessary Skills
Identifying: Time Elapsed
Sources of Investigators
Identifying: Most Important Strategies
Learning of Study Opportunities
Groups Providing Input
Seeking New Investigators
Selecting: Time Elapsed
Mapping the Path to Success
Selecting: Groups Involved
Selecting: Groups Involved
Selecting: Critical Factors
Selecting: Other Factors
Managing Investigator Mix
Selecting: Tactics Used
Cross-Referencing Question Probes
Pre-assessment Chart Reviews
Planning for Success
Precursors to Recruitment
Performance Curve Forecasting
Structure & Teams
Recruiting: Primary Responsibility
Therapeutic vs. Generalist
Knowledge-Sharing Leaders
Enrollment Strategy
Accountability for Relationships
Recruiting: Necessary Skills
Recruiting: Groups Often Involved
Recruiting: Time Elapsed
Investigator Recruitment Timing
Enhancing Productivity
Effective CRO Use
Assignment of Tasks to CROs
Tradeoffs of Using a CRO
Working with CROs
Preferred CRO Partner Benefits
Sponsor-CRO Collaboration
Communicating With One Voice
Developing Direct Relationships