Abstract
Preparing for Increased Regulatory Scrutiny of Investigator Compensation
The pharmaceutical industry' s commercial relationships with physicians and
thought leaders have fallen under intense scrutiny. The OIG, Congress, state
legislatures and consumer advocacy groups have all recently decried what they
view as unethically and insidiously harmful partnerships. The news is filled
with companies such as Pfizer, Merck, Eli Lilly and Medtronic bowing to public
pressure and the specter of the Physician Payments Sunshine Act - and
beginning to report payments to physicians exceeding certain limits. This year
the PhRMA instituted rigid rules concerning conduct in these relationships.
But the wave seems far from slowing. Both ACCME and academic institutions are
trying to separate themselves from undue industry influence through funding.
Harvard Medical School students recently began a campaign to purge the medical
school of industry connections with both faculty and the school, including
research partnerships, because they view these liaisons as endangering the
educational ability and prestige of the university. Faculty now must disclose
industry relationships to students, just as speakers at medical conferences
must.
The scrutiny and regulation are poised to start trickling over into the
clinical side of physician-industry relationships, most specifically concerned
with compensation of investigators leading clinical trials. Currently, the
focus appears to have settled on the effect of physicians consulting for
pharmaceutical companies. But the next logical step is the clinical side. In
fact, instances of investigation have already occurred, such as the one
concerning Emory University' s Charles Nemeroff' s work for GlaxoSmithKline.
Fair-market value and other regulatory issues for clinical relationships now
sit at a similar position as concern over commercial relationships did five
years ago. Now is the time for companies to be proactive and take steps to
counteract any imminent regulation or scrutiny. Companies should not wait to
ensure that neither carelessness nor ignorance causes a situation in which an
investigator appears to have been overcompensated. Even if the
overcompensation is not tied to unethical actions, given the current public
mood, it will reflect poorly.
Parsing out exact investigator compensation often proves difficult. Many
different costs, as well as different cost structures, are involved. Companies
differ on the best method by which to determine clinical costs, including
investigator compensation. The range varies from having set per-patient and
overhead costs depending on study and procedure, to looking at the individual
investigator' s salary and clinical expertise.
There is not one exact method of determining investigator compensation that is
consistent with both the market and the service rendered. A number of
different approaches will be discussed in this report. Yet no matter the
method, companies should always know, to the best of their ability, the amount
of funds going directly to the investigator or facility, as opposed to direct
costs such as procedures and drug costs.
Fortunately, unlike the commercial side, clinical operations already involve
protocols and guidelines that support or help guide operations toward FMV
compliance. Companies can incorporate FMV checks into Good Clinical Practices
(GCP) and regulatory concerns align with common-sense business practices.
Instituting FMV processes and developing a culture wary of compliance pitfalls
will ensure that a company avoids regulatory pains or expenses. Most often,
companies can successfully adhere to compensation compliance by simple
awareness, precise procedures and definitions and showing diligent attention
to specific costs.
Table of Contents
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
CHARTS AND GRAPHICS
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
