New Study From Cutting Edge Information Reveals That Regulations Are Considered Top Challenge for Investigator-Initiated Trials Departments

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 .

CONTACT: Eric Bolesh Email Contact 919-433-0209