SOURCE: Cutting Edge Information

Cutting Edge Information

March 05, 2015 09:30 ET

Most Investigator-Initiated Trial Teams Take at Least 60 Days to Negotiate IIT Contracts With Investigators

RESEARCH TRIANGLE PARK, NC--(Marketwired - March 05, 2015) - According to a recent survey by pharmaceutical intelligence firm Cutting Edge Information, the number of investigator-initiated trial (IIT) proposals that life science companies receive is increasing. As the volume of submissions grows, IIT management teams experience more pressure to expedite IIT evaluation timelines. The first step in optimizing these timelines, however, is to track metrics about the team's current practices.

It can take an IIT team anywhere between 38 days and 329 days to move a proposal from concept submission to contract negotiation, with an average of 156.1 days. Once a proposal reaches the clinical trial agreement (CTA) negotiation stage, surveyed teams average 70.5 days in between contract negotiation start and contract execution -- potentially adding severe delays to IIT timelines.

"Many companies approve and fund IITs to fill gaps in a product's portfolio or to fulfill other unmet needs," explained Natalie DeMasi, research analyst at Cutting Edge Information. "If it takes longer than expected for the trial to begin, the trial data may not be published for years. This delay denies the company, physicians and patients potentially useful data. Moreover, extended IIT timelines can drain team resources and frustrate investigators." 

According to Cutting Edge Information's newest report, "Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices," the two main reasons for prolonged CTA negotiation timelines are complex contract review processes and difficult negotiations. To simplify discussions, teams with fast CTA negotiations will often approach the investigator with a list of items that are nonnegotiable -- like intellectual property (IP) protection, for example. Contract negotiators armed with a list of the IIT team's requirements and flexible criteria will be poised to conduct efficient CTA negotiations.

"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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