Product Code: PH202
REPORT KEY FINDINGS
- Leverage multiple sources to calculate true, accurate fair-market value.
- Consider compensating investigators monthly on a per-patient visit basis.
- Weigh clinical trial details heavily to determine principal investigator
- Prepare for direct costs to keep quarterly budgets intact.
- Build precise investigator meeting budgets with itemized cost per attendee
WHY CLIENTS NEED THIS REPORT
- Build comprehensive trial budgets
- Build FMV calculation to fend off regulators
- Structure investigator contracts
- Plan for likely pass-through/direct costs from trial sites
- Prepare for an upcoming investigator meeting
This report's three (3) chapters showcase benchmarks and best practices for
developing a formal process to build fair-market value calculation, prepare
comprehensive trial budgets, structure investigator contracts, track trial
progress through payment schedules, and conduct successful investigator
- Metrics showing factors contributing to investigator compensation, as well
as companies' detailed assessments of their individual FMV processes.
- Criteria and strategic pointers for choosing the right principal
investigators & support staff, vetting sites and ensuring accountability for
- Data detailing average compensation for principal and supporting
investigators for trials in nine (9) major therapeutic areas.
- Charts showing prevalence of specific payment structures and milestones
used to compensate investigators.
- Average costs and ranges for key direct costs, including IRB fees,
recruitment costs, and pharmacy set-up fees.
- Expert recommendations on driving investigator meeting attendance and
increasing attendees' levels of engagement.
- Detailed benchmarks showing investigator meeting attendance and costs -
critical components to building precise budgets.
Data are split, where relevant:
- Rest-of-World (ROW)
- Therapeutic areas:
- CNS and neurology
- Endocrinology and Metabolic Diseases
- Infectious Disease
- Clinical teams
- Medical affairs teams
- Legal, Regulatory and Compliance teams
- Association of Clinical Research Professionals
- Purchasers/downloaders of:
- PH126: Managing Investigator Compensation
- PH152: Clinical Operations
- PH192: Clinical Development and Trial Operations
- PH180: Oncology Clinical Trials
- PH173: Phase I Clinical Trials
- Principal Investigator: These physicians assume ultimate
responsibility for a clinical trial at the designated investigator site. In
addition to performing and overseeing the medical interventions detailed
within the trial protocol, principal investigators' responsibilities include,
but are not limited to, patient inclusion/exclusion assessments, adverse event
reviews and serious adverse event reporting.
- Supporting Investigator: These physicians operate under the
supervision of the principal investigator at each trial site. Supporting
investigators may perform any, or all, of the medical interventions detailed
within the trial protocol.
- Compensation Limit: A self-imposed, annual limit placed on the
amount of money that a sponsor can compensate a physician or investigator
KEY QUESTIONS THIS REPORT ANSWERS
Promote Transparency by Building an Accurate Investigator FMV
- How do life science companies calculate FMV despite lack of formal
- While every trial's calculation process is unique, what are the three
common elements that will lead to true, accurate investigator FMV and
- Which factors do most surveyed companies consider when determining
investigator compensation, and why?
- What criteria do companies use to select the right investigators and
sites? How should they balance investigators' professional credentials and
clinical experience in the decision-making process?
- How can companies clearly outline trial responsibilities and increase
accountability within trial teams?
- How can companies prepare for trial delays when using academic
- During the feasibility stage, what questions should sponsors ask sites to
ensure that they receive an accurate picture of site capabilities?
Establish an Investigator Payment Schedule and Keep Trials on Track
- How much are principal investigators and supporting investigators paid per
visit, on average? How do these rates change depending on therapeutic area?
- What are the benefits of a payment structure and milestone payments?
- Which payment schedule is optimal for sponsors and investigators?
- How much should companies expect to budget for direct costs throughout
product development? (e.g., IRB fees, patient recruitment, testing and lab
fees, pharmacy set-up)?
Organize a Successful Investigator Meeting Within Budget
- What are companies' primary goals for an investigator meeting?
- What key factors should companies consider to organize a successful
- How can companies balance online technologies and traditional approaches
to boost investigator meeting attendance and involvement?
- What strategies can companies use to accurately budget for investigator
meetings and avoid surprises?
- How should companies effectively allocate their investigator meeting
budgets to cover specific costs (e.g., food, lodging and transportation)?
Table of Contents
CHAPTER BENEFITS AND METRICS BREAKDOWN
Chapter 1: Calculating Clinical Investigator Fair-Market Value (Author: Ryan)
The exact formula a company uses to calculate investigator FMV is not as
important as establishing a process in the first place. This chapter offers
benchmarks on the most critical factors to consider while calculating FMV
calculation and determining investigator compensation. This chapter also shows
benchmarks for compensation limits and average payments for principal
investigators and supporting investigators in eight common therapeutic areas:
cardiovascular, CNS and neurology, diabetes, gastroenterology, endocrinology,
infectious disease, oncology and urology.
- Establish a process to calculate FMV that fits company needs.
- Consider subscription services to fill in budget estimates.
- Document historic physician payments to build a cost database.
- Consult Medicare procedure reimbursement rates, then add overhead costs.
- Customize physician payments based on individual office visits.
- Weigh investigator experience and certifications when assessing
- Plan adequately for delays when using academic institutions.
- Establish clear accountability by outlining PI and staff responsibilities.
17 charts detailing how life science companies calculate investigator
fair-market value (FMV). The chapter contains process diagrams for
establishing an FMV process, as well as benchmarks for clinical trials across
a number of key therapeutic areas.
- Diagram showing elements of a standard investigator FMV calculation
- Percentage of companies considering specific factors to determine
investigator compensation (US, Europe, Asia)
- Infographic showing how to customize trial budgets using cost benchmarks
- Diagram showing FMV calculation process at a large medical device company
- Average investigator compensation for trials in these nine therapeutic
- CNS and neurology
- Endocrinology and metabolic disease
- Infectious disease
- Annual compensation limits for principal investigators
Chapter 2: Structuring Clinical Investigator Contracts and Pass-Through Costs (Author: Ryan)
This chapter focuses on payment structures and processes surrounding clinical
investigator compensation. It explores popular strategies and tactics used to
pay investigators as well as the different ways companies contract with
investigators. The chapter also examines common milestone payments, the number
of payments made to clinical investigators and withholding rates. Finally,
Chapter 2 provides ranges and averages of direct costs that investigators
often pass through to sponsors.
- Pay per patient visit to capture the cost of procedures and physicians'
- Establish compensation limits to ensure physicians are paid fair-market
- Use milestone payments to track trial progress and manage expectations.
- Build accurate budgets by planning for direct costs.
17 charts detailing the various facets companies consider when building a plan
for compensating clinical investigators.
- Payment structures used to compensate investigators (US, rest-of-world)
- Milestone payments in investigator contracts (US, rest of world)
- Number of payments to investigator in standard payment schedule
- Percentage of compensation withheld until trial completion
- Direct costs (by product lifecycle phase)
- Institutional Review Boards (IRB) fees
- Initial protocol review
- Continuing review
- Administrative termination
- Recruitment costs
- Equipment costs
- Pharmacy set-up fees
- Testing procedures and laboratory fees
- Document storage fees
- Office supplies
Chapter 3: Planning and Building Budgets for Investigator Meetings (Author: Natalie)
This chapter delves into the critical aspects necessary for focused and
engaging investigator meetings. To guide companies through these
recommendations, this chapter presents investigator meeting budgets by both
trial phase and reimbursed items. Interviewed executives offer ways to build
budgets and to simplify reimbursement processes. These meetings are an
opportunity for companies to train and engage physicians before a clinical
trial begins. To avoid regulatory censure, companies should ensure that
accommodations for these meetings are modest, and the meetings themselves
driven by scientific discussions. 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.
- Use cost per attendee metrics to build precise budgets.
- Review key factors - geography, timing and culture - to drive attendance.
- Project phase impact of attendance on travel, lodging and food budgets.
- Prioritize meeting convenience for attendees.
- Weigh pros and cons of online meetings.
21 charts detailing investigator meeting costs and budgets.
- Average number of investigator meeting attendees (by company and by phase)
- Percentage of companies reimbursing investigators for meeting costs, by
- Average total budget for investigator meetings (by phase and by company)
- Average investigator meeting cost per attendee (by phase and by company)
- Investigator meeting budget allocation (by percentage), by cost item
- Average cost per item, by phase