SOURCE: Cutting Edge Information

Cutting Edge Information

March 03, 2010 09:17 ET

75 Percent of Drug Companies Formally Manage Investigator-Initiated Trials

Cutting Edge Information Identifies Key Principles for IIT Success

RESEARCH TRIANGLE PARK, NC--(Marketwire - March 3, 2010) -  Investigator-initiated trials (IITs) provide companies with clinical data to expand scientific understanding of their drugs and reap a number of additional benefits. IIT management, however, can be challenging.

Data collected by business intelligence firm Cutting Edge Information show that 75% of surveyed companies have some form of dedicated IIT management group in place. Such teams accelerate IIT processing and help in long-term trial oversight.

"To translate strategic goals into a concrete plan of action, many companies have developed standard operating procedures for collecting, screening, and approving IIT proposals," said Jason Richardson, president of Cutting Edge Information. "IIT management teams save time, reduce confusion during the evaluation and approval process, and ensure that each study proposal receives a fair appraisal."

Companies have taken further steps to ensure tangible results from IITs -- and to find a range of uses for their results. To accomplish this goal, they have adopted hands-on IIT philosophies and increased oversight during trials.

"Even with standardized processes in place, the proposal-evaluation process can take a while," said Eric Bolesh, research director at Cutting Edge Information. "Rather than using a high-level committee to formally evaluate proposals -- only to reject them or find information missing -- IIT teams quickly identify proposals that are lacking necessary information or that are obviously bad fits for the company."

A key step in improving ongoing study management is managing investigators' expectations while clarifying their roles and responsibilities. This process begins even before a trial starts, as IIT groups quickly respond to trial proposals. During a study, some investigators expect to be left alone to run their studies, whereas others prefer regular contact, so IIT groups customize their approaches based on each investigator's needs and expectations.

While surveying teams who handle their companies' IIT processes, Cutting Edge Information (http://www.cuttingedgeinfo.com/) identified the following key principles for success:

  • Define IIT proposal protocols
  • Quickly eliminate undesirable proposals
  • Build dedicated IIT groups and budgets
  • Take a proactive approach to attracting, managing and using IITs
  • Manage investigators' expectations and clarify roles and responsibilities

For more inquiries about Cutting Edge Information's Clinical Development collection, visit: http://www.cuttingedgeinfo.com/reports/clinical-development.php.

Subscribe to Cutting Edge Information's free, monthly clinical newsletter, "CEInsider: Clinical Insights Edition" here: http://www.cuttingedgeinfo.com/news/newsletter.php.

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