FMV Budget is a Top Criterion Among Surveyed Companies When Evaluating IIT Proposals

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 21, 2017) - Nearly one-third of surveyed pharmaceutical companies look to fair-market value (FMV) budget as one their most important criteria for evaluating investigator initiated trial (IIT) proposals, according to a study by business intelligence firm Cutting Edge Information.

The study, Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices, found that many drug companies channel IIT submissions through a financial or budget department to conduct an FMV evaluation of the investigator's itemized budget.

Scrutiny over investigator fair-market value has increased since the Sunshine Act passed in 2009. The US Physician Payment Sunshine Act requires pharmaceutical companies to ensure that any money paid to a physician for a particular task is done so at fair-market value. And if the proposed budget is not FMV-compliant, the investigator must revise the budget or provide ample justification for each offending expenditure. Moreover, if the investigator does not submit a detailed budget for an FMV analysis, the proposal will be rejected.

"The first step toward a quality FMV review actually occurs before the investigator submits the IIT proposal," said Natalie DeMasi, research team leader at Cutting Edge Information. "Medical affairs teams need to effectively communicate the need for an itemized budget to be accompanied with each proposal."

However, IIT teams should not expect all new proposals to conform to fair-market value. The study revealed that the most common way of responding to IIT proposals is to send budgets back so investigators can make revisions themselves; 83% of surveyed IIT teams take this approach. A third of surveyed teams send an already revised budget back for the investigator to approve, sign and return to the company. Some teams take an even firmer stance with offending budget proposals. The line-item veto approach is used by 43% of teams, and 13% of teams reject proposals outright -- meaning if the proposal does not conform to FMV or is deemed too expensive, investigators are not given a chance for revisions.

Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices by Cutting Edge Information, available at, provides performance metrics about IIT evaluation timelines and the number of IIT submissions teams receive, evaluate and approve. The report also examines the structure of proposal evaluation committees and IIT budgets. Highlights from the report include:

  • Processes for receiving IIT submissions and investigator updates
  • Key criteria and red flags for evaluating IIT submissions
  • Case studies of itemized budgets for IIT approval, by therapeutic area
  • IIT trends, such as the number of research sites, target patient population and types of data collected

For more information about investigator-initiated trial management and IIT performance metrics, please download the report summary at:

Cutting Edge Information's FMVConnect Database

FMVConnect, a benchmarking and analysis solution by Cutting Edge Information, provides healthcare companies with the data necessary to build healthcare provider (HCP) relationships and to establish top-notch physician and non-physician fair-market value fee schedules.

A team of research experts has worked with thought leaders and pharmaceutical executives to develop a time-tested methodology for identifying and segmenting healthcare professionals and for determining fair-market value for specific thought leader activities. With Cutting Edge Information's FMV services, compliance executives can:

  • Implement a fee schedule based on detailed HCP compensation benchmarks
  • Establish sound consultant and advisor payment practices
  • Receive a customized data set based on your company's specific needs

FMV data for different thought leader activities are presented in tables and grouped by specialty, geographic region and tier. Our comprehensive database includes information from 115+ countries and 285+ specialty titles, including payer, patient and hospital administrator roles. For more information on FMVConnect, download the brochure at:

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Contact Information:


Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information

investigator-initiated trials, budget, clinical milestone payments