SOURCE: Cutting Edge Information

April 22, 2008 08:00 ET

New Study From Cutting Edge Information Shows That 45% of Investigator-Initiated Trial Proposals Reach Final Approval

RESEARCH TRIANGLE PARK, NC--(Marketwire - April 22, 2008) - Although some companies approve as few as 10% of their investigator-initiated trial (IIT) proposals, the industry average is closer to 45%, according to a new study from pharmaceutical intelligence leader Cutting Edge Information (www.investigatorinitiatedtrials.com).

Cutting Edge Information studied the IIT approval processes of 18 top pharmaceutical and biotechnology firms. After investigators submit their IIT proposals, they are typically entered into a company's tracking system, and the screening process begins. Approval rates ranged from as low as 10% to as high as 92% of proposals received. The discrepancy often lies in the pre-submittal screening process that companies have in place.

"Some pharmaceutical companies are working very diligently to weed out proposals of no value well before the investigator submits his proposal," said Eric Bolesh, research team leader at Cutting Edge Information. "Other companies will allow investigators to submit their proposals without any pre-screening process in place."

"Investigator-Initiated Trials: Building Superior IIT Capabilities" shows that 89% of IIT proposals reach a formal review committee. During first-pass analyses, review committees quickly identify proposals and weed out those that are lacking necessary information or that are obviously bad fits for the company. Only if a proposal passes this initial screening does it move on to the formal review committee.

To offer a comprehensive look at the current state of IIT management, Cutting Edge Information's study provides data benchmarks that will enable companies to improve their IIT initiatives. Findings center on the following topics:

--  Companies' assessments of IIT performance and areas of improvement
--  Study proposal review and evaluation timelines
--  Budgets and funding
--  IIT program profiles
    

One executive describes her company's selective process for pushing proposals through to committee. To help minimize the back-and-forth process between the review team and the investigator, her company uses a group of global research specialists to verify that a proposal meets all of the basic requirements before it ever reaches the formal committee -- in effect, this team serves as a prescreening function. If key pieces of information are missing from a proposal, the global research team requests them from the investigator.

Download a free summary of "Investigator-Initiated Trials: Building Superior IIT Capabilities" or purchase the report at: http://www.cuttingedgeinfo.com/investigatorinitiatedtrials/PH114_Download.asp#body.

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