SOURCE: Cutting Edge Information

Cutting Edge Information

June 28, 2016 08:17 ET

77% of Investigator-Initiated Trial Committees With Complete Voting Privileges Let High-Level Executives Make Final Decisions

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 28, 2016) - Investigator-initiated trial (IIT) review committees are often small and contain individuals from a variety of backgrounds. Most frequently, global- and local-level review committees include staff from legal, compliance, medical affairs and clinical teams. A recent study of pharmaceutical IIT committees found that of the 42% of surveyed committees that give each member voting privileges, 77% of these teams give high-level executives the final word on approval.

The study, Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant, published by Cutting Edge Information, also found that of the remaining 58% of surveyed committees that have voting and nonvoting members, 67% give their voting members the power to give final approval.

Although drug companies organize their Investigator-Initiated Trial (IIT) approval programs in different ways, most structures involve input from teams at both the local and global levels. Companies may also have more than one committee operating at local and global levels. Not all companies enable each of their committee members to vote. Commercial employees rarely have voting privileges, compared to their regulatory, medical affairs and clinical counterparts. Regardless of companies' preferred structures, some committees may also house commercial-facing personnel such as marketing and business development team members.

"Our research found that the number of IIT submissions is increasing and causing existing management challenges to magnify," said Natalie DeMasi, senior analyst at Cutting Edge Information. "The final outcome of an IIT isn't in the pharmaceutical company's hands, so the vetting process for each proposal is essential."

Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices is a complete guide of IIT best practices. The report, available at http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials/, provides benchmarks and best-in-class tactics for managing investigator-initiated trial programs. This report delves into each of these challenges -- IIT proposal selection, resources, performance metrics and compliance -- and serves as a guide to improving IIT management. It contains best practices and benchmarks for efficient and rigorous IIT evaluation.

Backed by quantitative and qualitative research, this study examines dedicated teams' roles and responsibilities. The report's highlights and metrics 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 about Cutting Edge Information's IIT benchmarking products and services, please visit www.CuttingEdgeInformation.com.

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