SOURCE: Cutting Edge Information

Cutting Edge Information

August 06, 2015 10:00 ET

New Study by Cutting Edge Information Finds Medical Affairs at the Helm of Pharmaceutical Investigator-Initiated Trial Approval Committees

RESEARCH TRIANGLE PARK, NC--(Marketwired - August 06, 2015) - Investigator-initiated trial (IIT) committees at life sciences companies may draw upon the expertise of external functions to ensure that involved teams remain apprised of IIT activities. According to a recent report by pharmaceutical intelligence firm Cutting Edge Information, medical affairs staff represents a common denominator across all surveyed global organizations.

The study, "Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices," found that all surveyed global teams report two to four medical affairs full-time employees on their dedicated IIT committees. Less frequently, organizations opt to involve business development and marketing staff. Teams may also involve drug safety or compliance personnel in their IITs.

Although global teams involve a number of functions in their IIT committees, not all of these members have voting privileges. In some cases, the types of committee members allowed to vote are consistent across surveyed teams. Comparing the number of global teams' total committee members against those who actually vote shows that medical affairs, clinical, regulatory and legal groups consistently report voting privileges.

"Companies that do not extend voting privileges to the entire IIT team typically leverage the expertise of medical and regulatory functions while limiting the contributions of commercial-facing groups," said Natalie DeMasi, senior research analyst at Cutting Edge Information.

"Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices," available at, provides performance metrics about IIT evaluation timelines and the number of IIT submissions teams receive, evaluate and approve. The report also examines the structure of proposal evaluation committees and IIT budgets. Highlights from the report include:

• Processes for receiving IIT submissions and investigator updates
• Key criteria and red flags for evaluating IIT submissions
• Case studies of itemized budgets for approved IITs, by therapeutic area
• IIT trends, such as the number of research sites, target patient population and types of data collected

For more information about "Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices" and IIT performance metrics, please download the report summary at

Contact Information