SOURCE: Cutting Edge Information

Cutting Edge Information

December 28, 2015 09:30 ET

50 Percent of Drug and Device Companies Lean on Thought Leader Management and Medical Science Liaison Teams for New Investigator-Initiated Trial Proposals

RESEARCH TRIANGLE PARK, NC--(Marketwired - December 28, 2015) - Roughly half of all surveyed global and U.S. pharmaceutical teams report involving key opinion leader (KOL) management or medical science liaison (MSL) teams in their investigator-initiated trial (IIT) proposal collection processes. A recent benchmarking study from primary intelligence firm Cutting Edge Information found that U.S. teams report more disparity in the functions involved in IIT proposal collection. 

Seventy-nine percent of surveyed U.S. teams involve medical affairs. However, unlike global teams, U.S. groups are less likely to involve a dedicated IIT group in the proposal screening process. Only 36 percent of U.S. teams assign partial responsibility for proposal screening to dedicated groups. A small percentage of teams also involve regulatory affairs, medical grants and drug safety functions.

The study, Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices, contains primary research collected from executives at Top 25 pharmaceutical companies, as well as life sciences firms of different sizes. These executives explained that while MSLs may support the IIT management process, they are not allowed to solicit physician for new proposals. Instead, to communicate trial opportunities, Top 25 companies typically leverage web-based resources owned by medical affairs organizations.

On the other side of the spectrum, small pharmaceutical companies may employ an online presence to describe the types of studies for which they seeking new IIT proposals. Other types of relevant information that companies' web sites may communicate include proposal submission and review schedules, submission review criteria, and IIT staff contact information.

The benchmarking report found that although companies' IIT programs may not change frequently, making sure that IITs are updated as needed is helpful when seeking the interest of outside parties. For example, small drug companies routinely update their websites to reflect current IIT needs and to stay abreast of changing regulations and products' evolving lifecycles.

"With the exception of global teams, more pharmaceutical companies involve medical affairs in proposal collection and initial screening than any other function," said Natalie DeMasi, senior analyst at Cutting Edge Information. "Teams with global responsibility typically position their dedicated IIT groups at the forefront of IIT collection." 

Dedicated groups are involved in proposal collection and IIT screening at 86 percent of surveyed global teams. The benchmarking analysis found that only 71 percent of global teams involve medical affairs in IIT collection and screening. Beyond these functions, some global groups also involve thought leader management and clinical/R&D teams-43 percent and 29 percent, respectively.

Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices is a complete guide of IIT best practices. The report, available at, provides benchmarks and best-in-class tactics for managing investigator-initiated trial programs. 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 on Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices, please visit

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