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.
Contact Information: CONTACT:
Eric Bolesh
919-433-0209