RESEARCH TRIANGLE PARK, NC–( EMWNews – April 2, 2008) – A new study released by Cutting

Edge Information finds that the biggest challenge facing organizations in

their investigator-initiated trials (IITs) is the investigators’ lack of

familiarity with the regulatory process. 38% of companies claim that

understanding the complexity of regulations regarding trials led by outside

investigators — and imparting that knowledge to the investigators — is

their most crucial concern. CEI’s report, “Investigator-Initiated Trials:

Building Superior IIT Capabilities,” examines IIT strategies, structures,

timelines and investments.

Historically drug companies have maintained a hands-off approach to IITs.

Often, due to lack of company oversight and organization, IITs ended before

completion. In other instances the data was unusable because the

investigator did not adhere to guidelines. With decreasing revenues and

limited pipelines, sponsoring companies have recently begun to proactively

oversee the trials to ensure that opportunities are not missed and funds

are not wasted.

“Until recently, the communication between companies and external

investigators has tended to be infrequent,” says lead author on the report,

Eric Bolesh. “However, many IIT management groups now attach milestones to

funding allocations and to regulatory guidelines to help foster more

frequent, results-driven communication.”

Current research shows that 75% of drug companies now have centralized IIT

management, up from the 50% found in a previous study by CEI. In addition,

60% of companies surveyed would like to further increase the size of their

IIT management department to increase their ability to review, oversee and

facilitate IIT endeavors.

To offer a comprehensive look at the current state of IIT management, the

report 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

    

Surveyed respondents reveal difficulties in selecting viable study

opportunities, tracking studies, overseeing clinical trial management and

making use of study findings. Beyond identifying these obstacles, however,

companies provide creative solutions. Based on data and these insights,

the report authors recommend strategies to optimize IIT performance.

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.