RESEARCH TRIANGLE PARK, NC--(Marketwired - March 18, 2015) - According to a new study by life sciences intelligence firm Cutting Edge Information, the average cost per investigator initiated trial (IIT) in 2014 was more than $100,000. While these funding requests vary greatly, companies must carefully scrutinize each proposal to ensure fair market value (FMV).

IIT managers surveyed for the study reported funding requests ranging from $10,240 for a urology chart review to $6.5 million for a 50-site, 1,000 patient multiple sclerosis study. On average, IIT teams fund $115,000 per study. 

"The average funding per study is a useful metric that investigator initiated trial teams can use to build annual budgets. For example, given a $1 million annual budget, a team knows that it can comfortably approve nine studies for the year," said Natalie DeMasi, senior research analyst at Cutting Edge Information. "It is important, however, that each proposal is independently measured against FMV standards."

To ensure FMV adherence, IIT reviewers should effectively communicate the need for an itemized budget with each study proposal. Line items can then be cross-referenced against internal and third-party databases. A budget outside of the acceptable limits can then be revised to maintain compliance. 

"Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices", 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 approved IITs, 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: Expedite Approval Timelines and Establish Compliant Funding Practices" and IIT performance metrics, please download the report summary at

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Rachel Shockley
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