Clinical Investigator FMV

$4,895.00

The benchmarks in this report are designed to help clinical managers determine how, what and when to pay clinical investigators. Findings help readers to leverage multiple sources to calculate accurate fair-market value, allocate principal investigator compensation, build comprehensive trial budgets and plan for pass-through costs. Teams can use the report’s insights to structure investigator contracts, keep quarterly budgets intact and build precise investigator meeting budgets.

Download Now! speak-to-an-expert

Report Details

Publication Date: August 2014
Pages: 102
Chapters: 3
Metrics: 400+
Charts/Graphics: 50+

Top Reasons to Buy This Clinical Investigator FMV and Compensation Benchmarks Report

Promote Transparency by Building an Accurate Clinical Investigator FMV Calculation Process: Average principal investigator compensation can range greatly depending on the physician’s therapeutic area.  To provide greater transparency for clinical trial payments, most companies have moved to systems that pay physicians based on the number and complexity of patient visits.  The study details how companies use benchmarking to understand the key differences in fair-market value payments for different specialists.  It also includes biopharmaceutical partners’ key lingo and clinical investigator activity definitions as well as metrics of companies’ annual compensation limits.

Establish an Investigator Payment Schedule and Keep Trials on Track: Clinical trials are unique by nature.  The payment structures that support these investigations also differ greatly from study to study.  Although compensation plans may be adjusted to better suit an individual trial, companies have developed several best practices to streamline the payment process.  Some of the insights contained in this study focus on the key considerations to building a payment plan for investigator compensation.  It also provides ranges and averages of direct costs that investigators often pass through to sponsors.

Organize a Successful Investigator Meeting within Budget: Investigator meetings are opportunities for investigators to become engaged with pharmaceutical companies and their products.  Many companies turn to vendors to plan, organize and even run their investigator meetings.  To prepare, event planners should build itemized budgets by calculating the cost per attendee. As a result, the number of participants will largely influence meeting budgets. The benchmarking data in this study delves into the critical aspects necessary for holding focused and engaging investigator meetings.  To guide companies through these recommendations, the study presents investigator meeting budgets by both trial phase and reimbursed items.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual clinical development research reports.

Excerpt from Clinical Investigator FMV and Compensation Benchmarks

Regulators worldwide are urging pharmaceutical companies to justify physician payments. This push includes all compensation for activities, including medical speeches, journal publications and clinical trial operations. Authorities are looking for greater transparency, and that starts with fair-market value (FMV) analysis. But life science companies have been left without concrete guidance on how to calculate FMV.

Rather than see this lack of guidance as a hurdle, some companies have decided to create a process that is tailored to their needs. More established organizations look to their own historic physician payments as a means to justify future payments, whereas smaller companies must rely on industry benchmarks to feed FMV calculations. Regardless of company size, however, polling the industry strengthens FMV justification.

Table of Contents

6             Executive Summary

8             Study Methodology

9             Study Definitions

10           Investigator Compensation: Five Recommendations for Success

22           Calculating Clinical Investigator Fair-Market Value

25           Factors Contributing to Fair-Market Value Calculation

37           Principal and Supporting Investigator Compensation Benchmarks

52           Structuring Clinical Investigator Contracts and Pass-Through Costs

53           Structuring Payment Methods to Reflect Trial Needs

65           Building Accurate Budgets by Planning for Direct Costs

77           Planning and Building Budgets for Investigator Meetings

78           Conducting Modest and Engaging Meetings to Promote Company Trust

83           Calculating Investigator Meeting Budgets

CHARTS AND GRAPHICS

6             Executive Summary

10           Figure E.1: Elements of Standard Investigator FMV Calculation

10           Investigator Compensation: Five Recommendations for Success

12           Figure E.2: Sample Investigator FMV Calculation for Company C

13           Figure E.3: Payment Structures Used to Compensate Investigators: All Companies

14           Figure E.4: Milestone Payments in Investigator Contracts: All Companies

16           Figure E.5: Average and Median Principal Investigator Compensation by Therapeutic Area

17           Figure E.6: Average Spending on Direct Costs Across Phases

20           Figure E.7: Average Investigator Meeting Costs, by Phase and Item

21           Figure E.8: Average Cost per Item, by Phase

22           Calculating Clinical Investigator Fair-Market Value

23           Figure 1.1: Elements of Standard Investigator FMV Calculation

25           Factors Contributing to Fair-Market Value Calculation

26           Figure 1.2: Factors Considered to Determine Investigator Compensation: All Companies

27           Figure 1.3: Factors Considered to Determine Investigator Compensation: US Companies

28           Figure 1.4: Factors Considered to Determine Investigator Compensation: European Companies

28           Figure 1.5: Factors Considered to Determine Investigator Compensation: Asian Companies

29           Figure 1.6: How to Customize Trial Budgets Using Cost Benchmarks

32           Figure 1.7: Sample Investigator FMV Calculation for Company C

37           Principal and Supporting Investigator Compensation Benchmarks

41           Figure 1.8: Average Investigator Compensation: Arthritis Trials

42           Figure 1.9: Average Investigator Compensation: Cardiovascular Trials

43           Figure 1.10: Average Investigator Compensation: CNS and Neurology Trials

44           Figure 1.11: Average Investigator Compensation: Diabetes Trials

45           Figure 1.12: Average Investigator Compensation: Endocrinology and Metabolic Disease Trials

46           Figure 1.13: Average Investigator Compensation: Gastroenterology Trials

47           Figure 1.14: Average Investigator Compensation: Infectious Disease Trials

48           Figure 1.15: Average Investigator Compensation: Oncology Trials

49           Figure 1.16: Average Investigator Compensation: Urology Trials

51           Figure 1.17: Annual Compensation Limit for Principal Investigator Pay, by Company

52           Structuring Clinical Investigator Contracts and Pass-Through Costs

53           Structuring Payment Methods to Reflect Trial Needs

56           Figure 2.1: Payment Structures Used to Compensate Investigators: All Companies

58           Figure 2.2: Payment Structures Used to Compensate Investigators: US Companies

59           Figure 2.3: Milestone Payments Used in Investigator Contracts: All Companies

61           Figure 2.4: Milestone Payments Used in Investigator Contracts: US Companies

62           Figure 2.5: Milestone Payments Used in Investigator Contracts: Rest-of-World Companies

63           Figure 2.6: Number of Payments to Investigator in Standard Payment Schedule

64           Figure 2.7: Percentage of Compensation Withheld Until Trial Completion

65           Building Accurate Budgets by Planning for Direct Costs

67           Figure 2.8: Direct Costs by Phase: IRB Fees – Initial Protocol Review

68           Figure 2.9: Direct Costs by Phase: IRB Fees – Continuing Review

69           Figure 2.10: Direct Costs by Phase: IRB Fees – Amendments

70           Figure 2.11: Direct Costs by Phase: IRB Fees- Administrative Termination

72           Figure 2.12: Direct Costs by Phase: Recruitment Costs

72           Figure 2.13: Direct Costs by Phase: Equipment Costs

73           Figure 2.14: Direct Costs by Phase: Pharmacy Set-Up Fees

75           Figure 2.15: Direct Costs by Phase: Testing Procedures and Laboratory Fees

75           Figure 2.16: Direct Costs by Phase: Document Storage Fees

76           Figure 2.17: Direct Costs by Phase: Office Supplies

77           Planning and Building Budgets for Investigator Meetings

78           Conducting Modest and Engaging Meetings to Promote Company Trust

83           Calculating Investigator Meeting Budgets

84           Figure 3.1: Average Number of Attendees: Investigator Meetings, by Phase

85           Figure 3.2: Average Number of Attendees, by Company: Phase 1 Investigator Meetings

86           Figure 3.3: Average Number of Attendees, by Company: Phase 2 Investigator Meetings

87           Figure 3.4: Average Number of Attendees, by Company: Phase 3a Investigator Meetings

87           Figure 3.5: Average Number of Attendees, by Company: Phase 3b Investigator Meetings

88           Figure 3.6: Average Number of Attendees, by Company: Phase 4 Investigator Meetings

89           Figure 3.7: Percentage of Companies Reimbursing Investigators for Meeting Costs, by Item

90           Figure 3.8: Average Total Budget for Investigator Meetings, by Phase

91           Figure 3.9: Average Total Budget for Investigator Meetings, by Company: Phase 1

92           Figure 3.10: Average Total Budget for Investigator Meetings, by Company: Phase 2

93           Figure 3.11: Average Total Budget for Investigator Meetings, by Company: Phase 3a

93           Figure 3.12: Average Total Budget for Investigator Meetings, by Company: Phase 3b

94           Figure 3.13: Average Total Budget for Investigator Meetings, by Company: Phase 4

95           Figure 3.14: Average Investigator Meeting Cost per Attendee, by Phase

96           Figure 3.15: Investigator Meeting Cost per Attendee, by Company: Phase 1

97           Figure 3.16: Investigator Meeting Cost per Attendee, by Company: Phase 2

98           Figure 3.17: Investigator Meeting Cost per Attendee, by Company: Phase 3a

99           Figure 3.18: Investigator Meeting Cost per Attendee, by Company: Phase 3b

99           Figure 3.19: Investigator Meeting Cost per Attendee, by Company: Phase 4

101        Figure 3.20: Investigator Meeting Budget Allocation, by Cost Item

102        Figure 3.21: Average Cost per Item, by Phase