Managing Clinical Investigator Compensation (PH126)
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- Published 2009
- 104 Pages
- 500+ Metrics
- 50+ Charts and Diagrams
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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.
Within five years, the 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 put themselves at great risk for compromised trial results, audits, financial damage and regulatory scrutiny. Diligence and constant monitoring go a long way toward preventing careless errors and potentially dangerous consequences.
Managing Clinical Investigator Compensation gives your company what it needs to be proactive and prepare for change while avoiding common pitfalls. CEI surveyed more than 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
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Companies and Therapeutic Areas Included in Investigator Compensation Research
Companies
The surveyed companies provided primary information either in the form of survey data or a telephone interview. Cutting Edge Information's analysts use secondary data to supplement the information provided by study participants. Responding companies include five top 20 and 10 Top 50 pharmaceutical companies, as well as biotechnology companies, medical device firms and third-party providers.
Therapeutic Areas
- Autoimmune
- Cardiology and Thrombosis
- CNS/Psychology
- Dermatology
- Endocrinology
- Gastroenterology
- Hematology
- Infectious Diseases
- Medical Devices
- Musculoskeletal
- Oncology
- Respiratory
- Women's Health
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Investigator Compensation Metrics
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
- 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 fees per site, the number of investigators per site (or CRO) and clinical investigator payments 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
- 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
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Investigator Compensation Report Sample
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.
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