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Products & Services Medical Affairs Clinical Trials

Investigator Initiated Trials Management

ID: POP-282


8 Info Graphics

37 Data Graphics

560+ Metrics

15 Narratives

Pages: 60

Published: Pre-2019

Delivery Format: Shipped


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As pharmaceutical and medical device companies improve their investigator-initiated trial (IIT) programs, it is critical to properly vet each proposal and approve the ones that demonstrate scientific merit and align with corporate objectives. Also, with a significant increase in the number of IIT submissions, it is important that organizations utilize their resources effectively to not let costs leapfrog results.

Best Practices, LLC published this
benchmarking report to provide a roadmap for improving IIT management at pharmaceutical and medical device companies, capturing critical metrics and insights on IIT management team structure, staffing, budget, IIT proposal evaluation, performance improvement, publication metrics and communication channels.

This report serves as a reference point for those who oversee or work in investigator-initiated trials so that they can compare the critical aspects of their IIT program with industry peers.

Industries Profiled:
Pharmaceutical; Biotech; Biopharmaceutical; Manufacturing; Consumer Products; Diagnostic; Medical Device; Health Care; Clinical Research; Laboratories

Companies Profiled:
Abbvie; Allergan; Alnylam Pharmaceuticals; Bayer; Boehringer Ingelheim; Cook Medical; Dexcom; Fresenius Medical Care; Fujirebio Diagnostics; Galderma; Grifols; Horizon Pharma; Kyowa Kirin; Medtronic; Merck; Pfizer; Pharmacyclics; Sanofi; Santen; Shire; Smith & Nephew; UCB Pharma; Vifor Pharma

Study Snapshot

Best Practices, LLC engaged 30 leaders from 23 pharmaceutical and medical device companies through a benchmarking survey. Nearly 60% of participants serve at the level of director or above. In-depth interviews were conducted with 4 executives to gather more detailed insights related to investigator initiated trials or studies.

Key topics in this report include:

  • IIT Submission Review and Systems
  • Functional Involvement and Responsibilities
  • SOPs and Impact of IIT Process
  • IIT Funding
  • IIT Audit
  • Future Improvements
  • Challenges to IIT Management Process
  • Important Criteria for IIT Evaluation
  • Key Reasons for Rejecting IIT Proposals
  • Publication Tactics
  • Communication Channels and Frequency

Key Findings

  • “Number of Publications” Is Top-Rated IIT Performance Metric: The top-rated IIT performance metric is total number of publications resulting from a study, a metric which 53% find highly effective. Close to one-third of companies also find the time taken by the review committee to approve a proposal and the total number of submissions received/approved to be highly effective ways of measuring overall IIT performance.
  • Strategic Fit and Scientific Merit Are Top Determinants of IIT Approval: The most highly rated criteria for evaluating new IIT proposals include “fit into company strategy” and “scientific merit.” Other important factors used by companies to evaluate IIT proposals include “reasonable budget,” “investigator qualifications,” and study “feasibility.” Conversely, the top reasons for which companies reject IIT submissions are strategic misalignment and high costs.

Other key insights uncovered are noted below. Detailed findings are available in the full report.

  • Medical Affairs Plays a Critical Role in IIT
  • MSLs are the Bridge Connecting Sponsors and Investigators
  • Majority of Companies Have a Dedicated IIT Management Group
  • IIT Department Structure Varies Widely from Company to Company
  • Almost All Companies Have Written SOPs
  • Average Annual IIT Management Budget of $4 Million, or $1 Million per FTE
  • Companies Allocate an Average of 4 FTEs to IIT Management
  • Access to Resources and Delays in Approval/Reviews are Top-Rated IIT Challenges
  • A Central Digital Management System is Key to IIT Efficiency
  • Quality and Budget are Top Parameters for IIT Auditing
  • IIT Updates are Typically Provided Either Quarterly and Monthly
  • Most IIT Submissions Occur in Face-to-Face Setting
  • Top Future Trend: IIT Becoming Increasingly Digitized, with ~50% Planning to Add an Online Portal or Centralized Data System
Table of Contents

I.Executive Summarypgs. 3-9
Research Overviewpg. 3
Participating Companiespg. 4
Key Findingspgs. 5-9
II.Activities and Responsibilitiespgs. 10-19
Therapeutic Area Responsibility
Functional Involvement and MSL’s Role
III.Reporting and Governancepgs. 20-29
IIT Types, Structure and Leadership Level
SOPs, IIT Process & Challenges
IV.Resource Allocationpgs. 30-40
IIT Budget and Staffing
IIT Committee Members & Review, Management
V.Performance Assessmentpgs. 41-48
Criteria for IIT Evaluation & Rejection
IIT Performance Management & Auditing
VI.Communicationpgs. 49-55
VII.Study Participant Demographicspgs. 56-58
VIII.About Best Practices, LLCpg. 60

    List of Charts & Exhibits

    Activities and Responsibilities
    • Therapeutic area responsibility for investigator initiated trial (IIT) submissions
    • Functions involved in leading roles in IIT management
    • Voices from the field: Roles played by Medical & Regulatory Affairs
    • IIT leadership roles: lead/co-lead, support role and no involvement
    • Involvement of various functions during proposal collection and initial screening of the IIT process
    • Involvement of various functions during IIT oversight
    • Involvement of various functions during IIT conclusion and use of data findings
    • Involvement of various functions during IIT publication
    • Role played by MSLs in IIT management

    Reporting and Governance
    • Whether benchmarked companies have a dedicated investigator initiated trial management department
    • Voices from the field: The importance of using a separate, dedicated team to manage investigator initiated trials
    • Structure of IIT management
    • Types of IIT studies supported by benchmark partners
    • Voices from the field: Growing interest in studies featuring patient-reported outcomes
    • Job title of the person heading IIT programs
    • Critical challenges to successful IIT structure & management
    • Impact of SOPs on investigator initiated trial process
    • Top challenges to the investigator initiated trial management process

    Resource Allocation
    • Number of FTEs dedicated to investigator initiated trial management within participating companies
    • Whether an IIT committee oversees the study selection process within participating companies
    • IIT committee membership and voting privileges
    • Frequency of IIT review committee meeting
    • Number of days spent by IIT committee on IIT submission review, approval and investigator notification
    • Payment milestones used for investigator initiated trials
    • Time spent on investigator initiated trial management
    • Approximate percentage of total number of approved IIT submissions, by study type
    • Whether benchmarked companies have a dedicated IIT funding
    • Total budget for investigator initiated trial management in the last fiscal year (USD)
    • Functions providing financial support to investigator initiated trials
    • Investigator initiated trial budget allocation
    • Anticipated trend over the next 24-36 months regarding IIT funding

    Performance Assessment
    • Important criteria to be considered when evaluating an IIT proposal
    • Reasons for automatically rejecting an IIT proposal
    • Top 3 approaches used to increase the efficiency of IIT review
    • Effectiveness of listed metrics in measuring IIT performance
    • Tactics used to ensure publication strategies are met
    • Parameters considered for auditing IIT
    • Plans for investigator initiated trial management process improvement

    • Preferred communication channels for receiving IIT updates
    • Frequency of investigator initiated trial updates
    • Number of global IITs published per year
    • Percentages of IITs published in each region
    • IIT submission channels
    • Voices from the field: Best practices for managing a robust investigator initiated trial program