RESEARCH TRIANGLE PARK, N.C.--(investigator-initiated trial (IIT) operations, according to a benchmarking study by Cutting Edge Information.)--Drug companies employ an average of 28 full-time equivalents (FTEs) around the world to oversee their
“Generally, within an individual country, very few FTEs focus solely on IIT management”
The study, “Investigator Initiated Trial Management,” found that global headcounts for IIT management reach across several business units, as well as countries in some cases. Some of these FTEs act as filters for a centralized global team — receiving and performing an initial screening on proposals submitted in their country, region or business unit.
IIT management teams primarily coordinate the processes surrounding these trials and the various other activities necessary to support the research. Companies do not maintain a particularly high amount of staffing to cover IIT management in the US, however. Cutting Edge Information’s data found that, on average, drug companies have 1.5 FTEs managing American IITs.
“Generally, within an individual country, very few FTEs focus solely on IIT management,” according to Ryan McGuire, research team leader at Cutting Edge Information. “For the most part, dealing with IIT management is merely a fraction of an individual’s job.”
Staffing for IIT management depends largely on two factors: company size and the amount of emphasis placed on IITs in general compared to company-sponsored studies. While size influences a company’s ability to amply support IIT management efforts, what tends to have an even greater impact are product portfolios and development drug pipelines. Extensive portfolios, successful franchises – or brands – and exciting drugs in development can spur an increase in volume of IIT proposals, which in turn, drives staffing needs.
Cutting Edge Information has studied pharmaceutical companies’ IIT processes since 2006. Its latest study, “Investigator Initiated Trial Management” (http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials/), contains benchmarks and best practices that enable better IIT management, from allocating resources efficiently to streamlining processes. The study also outlines several benefits to implementing an electronic submission system for IIT proposals, including:
• Receive more uniform and compliant proposals.
• Automate submission tracking, review, approval and KOL spend data.
• Provide payment history for regulatory compliance audits.
• Reduce the burden on medical science liaisons to drive IIT submissions.
For more information about investigator trial management, contact Elio Evangelista at 919-403-6583.