Facilitating Investigator-Sponsored Trials


The ninth module of the 10-part Medical Affairs Product Launch Series, this module is an analysis of key investigator-initiated trial (IIT) benchmarks, including budgetary and staffing data along with proposal submission and approval rates. It also examines teams’ IIT resource and activity levels during the product lifecycle and includes a detailed profile of budget, staffing and proposal submission timelines for a team supporting a product.

In developing this module, Cutting Edge Information’s analysts collected surveys from and consulted with a series of medical affairs leaders at several top pharmaceutical, biotechnology and medical device companies.

To learn more about the other modules in the Medical Affairs Product Launch Series and the benefits of subscribing to the entire series, click here 

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Facilitating Investigator-Sponsored Trials

Facilitating Investigator-Sponsored Trials is the ninth module of the 10-part Medical Affairs Product Launch Series. Based on primary research collected directly from executives leading top medical affairs teams, this module is designed to provide life science teams with important benchmarks to manage investigator-initiated trials resources effectively based on product strategy, market size and product type.

  • Publication Date: September 2017
  • Pages: 33
  • Figures: 14

To learn more about the other modules in the Medical Affairs Product Launch Series and the benefits of subscribing to the entire series, click here.

Top Reasons to Buy Investigator-Initiated Trials


Compare team investigator-initiated trial budgets and staffing levels to determine when to increase resource levels during the product lifecycle: Market size, the size of a product’s portfolio and IIT strategy all help to determine a team’s IIT budget. Research finds that although staffing levels remain fairly consistent throughout the product lifecycle, the number of full-time employees (FTEs) varies among IIT teams. The research and detailed profile in Facilitating Investigator-Sponsored Trials help teams determine the budget and staffing requirements needed to best support your company’s product launches.

Benchmark IIT proposal submissions throughout the product lifecycle to prepare IIT teams for activity level increases: The lifecycle stage at which teams receive the most IIT proposal submissions, activity levels adjust accordingly. This module discusses the change in workload throughout the product lifecycle and how that corresponds to activity levels and the percentage of proposals that get approved. Use the research in Facilitating InvestigatorSponsored Trials to adjust resources to meet workload demands.

Excerpt: Product Type Drives IIT Activity Timelines

Some surveyed life science teams begin IIT functions as early as Phase 2 of clinical trials. Others wait until after product launch. Data suggest that the type of product that a team supports has an impact on its activity timeline. Figure 1.9.2 gives a timeline of the cumulative percentage of surveyed teams that begin IIT activities during each product lifecycle stage, by product type.

  • Surveyed teams that support niche products begin activities, on average, earlier than teams supporting other types of products. This could be a strategy to gather more data about niche product patient populations — which are typically less well understood — before product launch. Twenty percent of niche product teams begin activities during Phase 2a, and 40% start by Phase 3a.
  • No surveyed common product team begins activities until Phase 3a. During this phase, 25% of teams that support common products begin IIT activities. By product registration/launch, 50% begin.

Examples of Companies That Have Participated in This Study:

Participating Companies