SOURCE: Cutting Edge Information

Cutting Edge Information

June 30, 2015 09:30 ET

87% of IIT Teams Use Achieving Target Patient Enrollment as a Milestone Payment, According to Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 30, 2015) - Increased regulatory and compliance concerns mean that investigator-initiated trial (IIT) teams have to be especially careful about who and what they fund. As a result, IIT teams thoroughly vet each proposal before approving it. However, even after approval, IIT teams follow-up with investigators to ensure they are conducting their trials according to plan.

One common method teams use to ensure investigators are using their IIT funding appropriately is milestone payments. In fact, according to "Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices," a report by pharmaceutical intelligence firm Cutting Edge Information, 100% of surveyed teams use milestone payments. Typical milestones include IRB approval, submission of interim study report and submission of manuscript for publication. However, the most common milestone payment -- used by 87% of surveyed teams -- is achieving target patient enrollment.

"Essentially, companies pay investigators based on the level of work they perform," explained Natalie DeMasi, senior analyst at Cutting Edge Information. "If an investigator is unable to recruit sufficient numbers of patients, the company will request that additional funds be returned. These milestones serve the dual purpose of ensuring that trials stay on track and that companies remain prudent as they fund IIT trials."

The key to milestone payments is receiving timely updates from investigators about their progress. These updates may be as simple as emails or phone calls, or medical science liaisons (MSLs) may personally visit the investigator to learn about trial progress. Nevertheless, 45% of surveyed teams have investigators submit IIT updates via a company-sponsored portal or website. These portals offer both teams and investigators an efficient and transparent means for communicating any IIT concerns and tracking updates.

"Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices" provides IIT compliance best practices and case studies of itemized IIT payments, by therapeutic area. The report, which is available at http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials,
also examines the structure of proposal evaluation committees and IIT submissions evaluation criteria and performance metrics. Highlights from the report include:

  • Percentage of IIT budget dedicated at the beginning of the fiscal year
  • Processes for receiving IIT submissions and investigator updates
  • Timeline metrics for the number of days it takes teams to evaluate submissions and negotiate clinical trial agreements (CTAs)
  • The number of IIT submissions teams receive, evaluate and approve for 2013, 2014 and 2015

For more information about "Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices" and IIT budgets, please visit http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials/.

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