Managing Clinical Investigator Compensation

Publication Date	May 2009
Publisher	Cutting Edge Information
Product Type	Report
Pages	104
ISBN Number	not applicable
Product Code	CUT00079

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Summary

The most up-to-date clinical investigator compensation benchmarks

Improve cost-effectiveness of investigator compensation - and ensure compliance.

Establishing transparent and defensible compensation processes for clinical investigators not only saves money - it is absolutely essential in today's restrictive pharma landscape. Regulatory groups, legislative bodies and consumer advocacy groups are applying relentless pressure on commercial relationships with physicians, altering and often limiting industry practices. Now the ripple effect is hitting clinical operations. Some investigations in the area have garnered public attention, with more bound to follow.

Cutting Edge Information projects that within five years the same regulatory scrutiny currently on the commercial side will expand to the clinical side. Companies that do not recognize this inevitable reality and formalize their FMV processes today put themselves at great risk for compromised trial results, an audit, financial damage and regulatory scrutiny. Diligence and constant monitoring will go a long way to preventing careless errors and courting potentially dangerous consequences.

Managing Clinical Investigator Compensation (PH126) gives your company what it needs to be proactive and prepare for change while avoiding common pitfalls. CEI surveyed over 50 companies of all types and sizes, across 13 different therapeutic areas, for the most up-to-date compensation rates for clinical investigators. For the most comprehensive analysis, CEI compiled and analyzed data from companies' clinical operations as well as primary investigators.

Use the data benchmarks to:

Control costs
Establish current, market based payments to investigators
Develop regulation-proof calculation and documentation methods
Stay current on the latest FMV regulation concerns and trends

500+ Metrics

50+ Charts and Diagrams

Managing Clinical Investigator Compensation's three chapters include compensation data collected from clinical investigators as well as pharmaceutical, biotechnology and medical device companies. Data include breakdowns by phase, therapeutic area and experience.

Investigator Compensation: Industry Data

Percentage of time that companies monitor negotiations between CROs and investigators
Percentage of companies that hire CROs to recruit investigators
Percentage of companies that hire CROs to contract investigators
Percentage of time that CROs handle investigator payments
Percentage of companies with a formal process in place for determining investigator compensation
Percentage of companies that allow primary investigators to concurrently lead clinical trials for other companies
Experience level
Average years of experience required for primary investigators, by phase
Average years of experience required for primary investigators, by company type and by phase

Articles published and speeches delivered

Percentage of companies whose criteria for primary investigators include published articles
Average number of published journal articles required of primary investigators, by phase
Percentage of companies with investigator compensation limits in place
Average number of total site fees by phase
Average number of investigators per site, by phase

Investigator Compensation by Therapeutic Area

Cutting Edge Information collected data from 13 different therapeutic areas and from medical devices (in a separate data set). The report includes three sets of therapeutic area benchmarks: average total feesm per site, the number of investigators per site (or CRO) and investigator compensation per phase for the following therapeutic areas:

Autoimmune
Cardio & Thrombosis
CNS & Psychology
Dermatology
Endocrinology
Gastroenterology
Hematology
Infectious Diseases
Musculoskeletal
Oncology
Respiratory
Women's Health

Investigator Compensation: Investigator Data

Percentage of investigators involved in each type of clinical trial
Number of trials that an average investigator is currently leading, by category
Average number of companies that investigators have run trials for, by years
Years of experience by investigator type (i.e., primary or secondary)

Speeches and publications

Percentage of investigators who deliver speeches
Number of speeches delivered in the past year, by investigator type
Number of articles written and published, by investigator type

Investigator fees

Average per site total fees by phase
Average primary investigator hours, by phase
Average primary investigator hourly rates, by phase
Average percentage of total fees allocated to primary and secondary investigators, by phase
Average primary investigator compensation - total and per patient - by phase
Average secondary investigator compensation - total and per patient - by phase
Primary investigator compensation by years of experience
Years of experience necessary for significant difference in primary investigator compensation, by phase
Average compensation for Phase 1 (and Phase 2, 3, and 4) primary investigators based on years of experience

Sample Content from the Report

The following excerpts are taken from Chapter 2, "Investigator Compensation: Industry Data." The full chapter contains extensive data from drug and device manufacturers that indicate their processes, criteria for selecting investigators and compensation limits.

Base Investigator Compensation on Established Criteria

The level of an investigator's compensation is not the precise concern for many clinical development executives. More accurately, executives are concerned about cost control for clinical studies and how investigators' pay contributes to overall trial costs. Therefore, companies investigating the levels of investigators' pay look for strategies to keep overall costs down while continuing to compensate physicians fairly.

Some clinical executives have taken the lead from commercial counterparts by establishing a set of criteria upon which they budget investigator compensation as part of the overall clinical trial cost. These criteria often include the investigator's years of experience, the number of articles she has published and, to a small degree, how many speeches she has delivered.

At the same time, a small percentage of companies are concerned that their investigators do not dedicate enough time to their companies' specific studies, or that there may be bias issues when investigators lead trials for multiple companies at the same time. For instance, if an oncologist is involved in two separate clinical studies for different companies, he may be unintentionally biased toward one treatment based on his experience working on that drug's clinical trial. The investigator may, therefore, recruit more patients for the competitor trial. In another example, some companies would rather not compensate a specialist who will help promote a competitor's treatment at the same time as their own.

These concerns by a small minority proved untenable, according to Cutting Edge Information's research. Survey data show that very few companies sign exclusive contracts with primary investigators. Across all company types, only 8% of respondents call for primary investigators to run trial exclusively for their products, as shown in Figure 2.6 [figures appear in full report].

For that matter, a significant number of participating companies do not contract directly with investigators. Most of the time...

The following excerpt is taken from Chapter 3, "Investigator Compensation: Investigator Data." The full chapter examines data provided by clinical investigators. It contains a detailed breakdown of primary and secondary investigator compensation.

Phase 1 experience shows the greatest percentage increase among all the phases, once the primary investigator reaches the experience threshold. Figure 3.18 [figures appear in full report] reveals that primary investigators with over 11 years experience receive 155% more than investigators with less than 11 years of experience.

Primary investigators for Phase 2 receive the lowest percentage pay increase when

crossing the experience threshold of 14 years. Figure 3.19 [figures appear in full report] shows that primary investigators with over 14 years experience receive 52% more than investigators with less than 14 years of experience.

Phase 3a trials are the most critical test in a drug's development, and in this case, experience does pay. Primary investigators earn the highest total fees and highest hourly wages for Phase 3a trials.

Content

Executive Summary
- Study Methodology
- Study Definitions
- Profiled Companies And Therapeutic Areas
- Five Key Findings And Recommendations
Investigator Compensation In A Constricting Regulatory Environment
- An Fmv Process: A Requirement Beyond Simple Cost Determinations
- Contracting With Sites
Investigator Compensation: Industry Data
- Developing Processes To Determine Investigator Compensation
- Investigator Compensation Data
Investigator Compensation: Investigator Data
Executive Summary
- Figure E.1: Comparison Of Primary Investigator Compensation Data Between
- Companies And Investigators
- Figure E.2: Percent Difference In Reported Compensation
- Figure E.3: Average Salary For Primary Investigators With Greater Than Or
- Less Than The Necessary Years Of Experience By Phase
Investigator Compensation In A Constricting Regulatory Environment
Investigator Compensation: Industry Data
- Figure 2.1: Percentage Of Time That Companies Monitor Negotiations Between
Cros And Investigators
- Figure 2.2: Percentage Of Companies That Hire Cros To Recruit Investigators
- Figure 2.3: Percentage Of Companies That Hire Cros To Contract Investigators
- Figure 2.4: Percentage Of Time That Cros Handle Investigator Payments
Developing Processes To Determine Investigator Compensation
- Figure 2.5: Percentage Of Companies With A Formal Process In Place For
- Determining Investigator Compensation
- Figure 2.6: Percentage Of Companies That Allow Primary Investigators To Concurrently
- Lead Clinical Trials For Other Companies
- Figure 2.7: Percentage Of Companies That Contract Directly With Primary Investigators
- Figure 2.8: Average Years Of Experience Required For Primary Investigators By Phase
- Figure 2.9: Average Years Of Experience Required By Small Companies For
- Primary Investigators By Phase
- Figure 2.10: Average Years Of Experience Required By Large Companies For
- Primary Investigators By Phase
- Figure 2.11: Average Years Of Experience Required By Mid-Size Companies For
- Primary Investigators By Phase
- Figure 2.12: Average Years Of Experience Required By Medical Device Companies For
- Primary Investigators By Phase
- Figure 2.13: Percentage Of Companies Whose Criteria For Primary Investigators
- Include Published Articles
- Figure 2.14: Average Number Of Published Journal Articles Required Of Primary
- Investigators By Phase
- Figure 2.15: Percentage Of Companies Whose Criteria For Primary Investigators
- Include Speeches
- Figure 2.16: Percentage Of Companies With Investigator Compensation Limits In Place
Investigator Compensation Data
- Figure 2.17: Average Number Of Total Site Fees By Phase
- Figure 2.18: Average Number Of Investigators Per Site By Phase
- Figure 2.19: Average Primary Investigator Compensation By Phase
- Figure 2.20: Autoimmune: Average Number Of Total Site Fees By Phase
- Figure 2.21: Autoimmune: Average Number Of Investigators Per Site By Phase
- Figure 2.22: Autoimmune: Average Primary Investigator Compensation By Phase
- Figure 2.23: Cardio & Thrombosis: Average Number Of Total Site Fees By Phase
- Figure 2.24: Cardio & Thrombosis: Average Number Of Investigators Per Site By Phase
- Figure 2.25: Cardio & Thrombosis: Average Primary Investigator Compensation
- By Phase
- Figure 2.26: Cns & Psychology: Average Number Of Total Site Fees By Phase
- Figure 2.27: Cns & Psychology: Average Number Of Investigators Per Site By Phase
- Figure 2.28: Cns & Psychology: Average Primary Investigator Compensation By Phase
- Figure 2.29: Dermatology: Average Number Of Total Site Fees By Phase
- Figure 2.30: Dermatology: Average Number Of Investigators Per Site By Phase
- Figure 2.31: Dermatology: Average Primary Investigator Compensation By Phase
- Figure 2.32: Endocrinology: Average Number Of Total Site Fees By Phase
- Figure 2.33: Endocrinology: Average Number Of Investigators Per Site By Phase
- Figure 2.34: Endocrinology: Average Primary Investigator Compensation By Phase
- Figure 2.35: Gastroenterology: Average Number Of Total Site Fees By Phase
- Figure 2.36: Gastroenterology: Average Number Of Investigators Per Site By Phase
- Figure 2.37: Gastroenterology: Average Primary Investigator Compensation By Phase
- Figure 2.38: Hematology: Average Number Of Total Site Fees By Phase
- Figure 2.39: Hematology: Average Number Of Investigators Per Site By Phase
- Figure 2.40: Hematology: Average Primary Investigator Compensation By Phase
- Figure 2.41: Infectious Diseases: Average Number Of Total Site Fees By Phase
- Figure 2.42: Infectious Diseases: Average Number Of Investigators Per Site By Phase
- Figure 2.43: Infectious Diseases: Average Primary Investigator Compensation By Phase
- Figure 2.44: Musculoskeletal: Average Number Of Total Site Fees By Phase
- Figure 2.45: Musculoskeletal: Average Number Of Investigators Per Site By Phase
- Figure 2.46: Musculoskeletal: Average Primary Investigator Compensation By Phase
- Figure 2.47: Oncology: Average Number Of Total Site Fees By Phase
- Figure 2.48: Oncology: Average Number Of Investigators Per Site By Phase
- Figure 2.49: Oncology: Average Primary Investigator Compensation By Phase
- Figure 2.50: Respiratory: Average Number Of Total Site Fees By Phase
- Figure 2.51: Respiratory: Average Number Of Investigators Per Site By Phase
- Figure 2.52: Respiratory: Average Primary Investigator Compensation By Phase
- Figure 2.53: Women's Health: Average Number Of Total Site Fees By Phase
- Figure 2.54: Women's Health: Average Number Of Investigators Per Site By Phase
- Figure 2.55: Women's Health: Average Primary Investigator Compensation By Phase
- Figure 2.56: Medical Devices: Average Number Of Total Site Fees By Phase
- Figure 2.57: Medical Devices: Average Number Of Investigators Per Site By Phase
- Figure 2.58: Medical Devices: Average Primary Investigator Compensation By Phase
Investigator Compensation: Investigator Data
- Figure 3.1: Percentage Of Investigators Involved In Each Type Of Clinical Trial
- Figure 3.2: Number Of Trials That An Average Investigator Is Currently Leading
- By Category
- Figure 3.3: Average Number Of Companies That Investigators Have Run Trials For
- By Years
- Figure 3.4: Years Of Experience By Investigator Type
- Figure 3.5: Percentage Of Investigators Who Deliver Speeches
- Figure 3.6: Number Of Speeches Delivered In The Last Year By Investigator Type
- Figure 3.7: Number Of Articles Authored And Published By Investigator Type
- Figure 3.8: Average Per-Site Total Fees By Phase
- Figure 3.9: Average Primary Investigator Hours By Phase
- Figure 3.10: Average Primary Investigator Hourly Rates By Phase
- Figure 3.11: Average Percentage Of Total Fees Allocated To The Primary Investigator
- By Phase
- Figure 3.12: Average Percentage Of Total Fees Allocated To The Secondary Investigator
- By Phase
- Figure 3.13: Average Primary Investigator Total Compensation By Phase
- Figure 3.14: Average Primary Investigator Compensation Per Patient By Phase
- Figure 3.15: Average Secondary Investigator Total Compensation By Phase
- Figure 3.16: Average Secondary Investigator Compensation Per Patient By Phase
- Figure 3.17: Years Of Experience Necessary For Significant Difference In Primary
- Investigator Compensation By Phase
- Figure 3.18: Average Compensation For Phase 1 Primary Investigators Based On
- Years Of Experience
- Figure 3.19: Average Compensation For Phase 2 Primary Investigators Based On
- Years Of Experience
- Figure 3.20: Average Compensation For Phase 3a Primary Investigators Based On
- Years Of Experience
- Figure 3.21: Average Compensation For Phase 3b Primary Investigators Based On
- Years Of Experience
- Figure 3.22: Average Compensation For Phase 4 Primary Investigators Based On
- Years Of Experience