SOURCE: Cutting Edge Information

May 08, 2008 09:13 ET

60% of Investigator Initiated Studies Result in New Medical Publications, Says Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - May 8, 2008) - A recent study found that only 60% of investigator initiated clinical trials (IITs) result in new medical publications. The finding emphasizes a gap in the pharmaceutical industry's desire to publish new research findings and its ability to meet a primary goal of every investigator sponsored study.

Once the data from IITs are published, companies use the information to arm their field forces, according to pharmaceutical intelligence firm Cutting Edge Information. IIT findings appear in sales force materials and in content distributed to the medical community through medical education materials. Promotional materials such as posters, and detail aids reflect the data that appear in publications. But none of these are possible when IITs do not result in publication.

"The lack of publications can be a serious problem for pharmaceutical companies desperate to promote new findings," said Eric Bolesh, research team leader at Cutting Edge Information. "As the pharma industry continues to struggle to launch new drugs, it has to rely on existing products to hit escalating financial goals. IITs have been a solution to finding new uses for old medicines."

"Investigator-Initiated Trials: Building Superior IIT Capabilities," available at, finds that although publications are not the only goal for pursuing an investigator sponsored study, they are a valuable vehicle for promoting new research and meeting expanded needs for patients.

Cutting Edge Information studied the IIT approval processes of 18 top pharmaceutical and biotechnology firms. The 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 interviewed for the study plainly states, "We want publications." Another executive said, "Nine out of ten times, the use is publications," referring to how his company uses the findings from an IIT. When labels are particularly narrow, IIT data prove very useful. Approved indications and dosages may trail behind actual use in the field.

Download a free summary of "Investigator-Initiated Trials: Building Superior IIT Capabilities" or purchase the report at:

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