SOURCE: Cutting Edge Information

Cutting Edge Information

February 27, 2015 09:30 ET

91% of Surveyed Pharma Teams have at Least One Dedicated Investigator-Initiated Trials (IIT) Management Team

Dedicated Teams Streamline Existing Management Procedures

RESEARCH TRIANGLE PARK, NC--(Marketwired - February 27, 2015) - Investigator-initiated trials (IITs) are important to any life science company's long list of medical and clinical activities. Teams must ensure that these studies are selected prudently and, once approved, remain primarily at the discretion of independent, third party clinicians. Some companies elect to manage IITs as part of their medical affairs responsibilities. Others organize this function outside of their medical affairs team's scope. However, according to pharmaceutical intelligence provider Cutting Edge Information, one thing is certain: with 91% of surveyed teams reporting dedicated IIT groups -- a dramatic uptick from 50% of surveyed teams in 2006 -- IIT management is not to be overlooked.

Teams may enlist a myriad of different structural organizations to support IIT collection, processing and approval. For example, US teams may predominantly organize their IIT management groups by business unit. Groups outside the US may prefer to segment their teams by either region or therapeutic area.

Regardless of the structure selected, dedicated groups work to streamline existing IIT management procedures. In its recent investigator-initiated trial benchmarking study, Cutting Edge Information found that 86% of surveyed global groups involve their dedicated teams in the proposal collection and initial screening processes. Beyond including clinical and medical affairs groups, 71% of surveyed companies also leverage IIT teams to assist in formal review activities. 

"Dedicated teams can expedite approval processes and -- with the help of additional technologies -- keep investigators apprised of proposal status," said Natalie DeMasi, research analyst at Cutting Edge Information. "Likewise, it's unsurprising that many surveyed companies involve them during every step of the IIT management process." 

"Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices" discusses a myriad of IIT best practices. Available at http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials/, this report provides benchmarks and best practices for managing investigator-initiated trial programs. Backed by quantitative and qualitative research, this study examines dedicated teams' roles and responsibilities. Highlights include:

  • Structural and staffing recommendations regarding companies' dedicated IIT management teams
  • Strategic, step-by-step analyses of IIT progression: from submission to first patient enrolled, including best practices for speeding up associated timelines
  • An enhanced look at IIT budgets from average overall costs to specific expenditures

For more information on "Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices", please visit http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials/.

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