Investigator-Initiated Trial Proposals Should Pass a Fair Market Value Assessment Prior to Approval, According to Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - October 14, 2015) - Given today's regulatory climate, an investigator-initiated trial (IIT) can do a company more harm than good if payments are deemed excessive. As such, most Top 25 pharmaceutical companies in the United States require that IIT proposals pass a fair market value (FMV) assessment before the proposal is approved by a company's IIT committee, according to research from life sciences intelligence firm Cutting Edge Information.

"If an IIT proposal does not fall within established fair market value limits, an investigator must revise the budget or provide ample justification for each offending expenditure," said Natalie DeMasi, senior research analyst at Cutting Edge Information. "Otherwise, if the investigator fails to comply with FMV guidelines, the proposal will be rejected."

The first step toward a quality FMV review actually occurs before the investigator submits the proposal. Teams must effectively communicate the need for an itemized budget to be accompanied with each proposal. Most companies make this abundantly clear on the IIT website or through the submission portal. But if for some reason the website does not list proposal requirements, medical science liaisons can also remind investigators to submit detailed budgets.

Once the itemized budget is submitted, teams cross-reference each activity in the trial protocol against internal and third-party databases. For current industry benchmarks, most teams subscribe to clinical benchmarking services such as TTC's GrantPlan or Medidata's Grants Manager. These services use actual costs paid for medical procedures and then drill down to the country level -- and sometimes offer site-level benchmarks.

Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices by Cutting Edge Information, available at http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials/, 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 http://www.cuttingedgeinfo.com/download/?ref=156.

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 key opinion leader relationships and to establish top-notch physician and non-physician fair market value fee schedules.

Our 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, you can:

• Implement a fee schedule based on detailed KOL 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 118 countries, 109 specialties/subspecialties and 63 non-specialties. For more information on FMVConnect, download the brochure at http://www.cuttingedgeinfo.com/download/?ref=24426.