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Best Practices in the Oversight and Management of Investigator Initiated Trials

ID: POP-327


8 Info Graphics

41 Data Graphics

610+ Metrics

14 Narratives

Pages: 65

Published: 2020

Delivery Format: Shipped


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The number of investigator-initiated trial (IIT) submissions in the healthcare industry has increased in recent years, marking them as a critical operational area for most biopharma manufacturers.

Successful companies must manage a series of challenges in this area, including: proper vetting of proposals, approvals for those that demonstrate scientific merit and align with corporate strategy, and effective utilization of resources to ensure costs do not outrun results.

Best Practices, LLC has created this benchmarking report to help biopharma leaders improve IIT management, delivering critical data on insights on IIT management team structures, staffing trends, budget levels and performance assessment metrics.

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

Companies Profiled:
Alcon; Allergan; Arena Pharmaceuticals; Bayer; Beckman Coulter; Becton Dickinson; Biofrontera; Bioventus; Blue Earth Diagnostics; Cipla; Daiichi Sankyo; Edwards Lifesciences; Eisai; EMD Serono; Fidia; Gedeon Richter ; Grifols; Guerbet; Ipsen; Jazz Pharmaceuticals; Julphar; Karyopharm Therapeutics; Lundbeck; Merck; Merz Pharma; Novartis; Sage Therapeutics; Sandoz; Sanofi; Santen; Seqirus; Solidfarma; Takeda Pharmaceuticals; Terumo Corporation

Study Snapshot

Best Practices, LLC engaged 46 leaders from 34 bio-pharmaceutical and medical device companies in this research through a benchmarking survey. Nearly three-fourths of the respondents serve at the director level or above.

Key topics covered in this report include:

  • IIT Submission Review and Systems
  • Functional Involvement
  • IIT Funding
  • Future Improvements
  • Challenges
  • Important Criteria for IIT Evaluation
  • Key Reasons for Rejecting IIT Proposals

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • Strategic fit and scientific merit most often determine IIT approval; high costs and strategic misalignment lead to IIT denials
    • The most used criteria for evaluating new IIT proposals were “strategic fit” and “scientific value.”
    • Some companies also evaluate based on “clinical feasibility” and “potential impact.” IIT denials occur most often because of strategic misalignment and high costs.
  • Companies are requiring more frequent IIT updates
    • Cycle times are shrinking for key IIT categories, such as (1) protocol review to protocol decision; (2) protocol decision to contract negotiation start, and (3) contract execution to first patient in study.
Table of Contents

Sr. No.
Slide No.
Overviewpgs. 3-6
Research Overviewpg. 4
Universe of Learningpgs. 5-6
Key Findings and Insightspgs. 7-9
Activities and Responsibilitiespgs. 10-19
Governance and SOPs with IITspgs. 20-23
IIT Committeepgs. 24-30
Proposal Evaluationpgs. 31-33
Review Process in IITpgs. 34-38
Resource Allocationpgs. 39-49
Investigator Networkingpgs. 50-51
Payment Milestonespgs. 52-55
Communicationpgs. 56-58
Future Prospectspgs. 59-62
Participant Demographicspgs. 63-64
About Best Practices, LLCpg. 65

    List of Charts & Exhibits

    I. Activities and Responsibilities

    • Presence of a dedicated IIT management department within benchmarked companies
    • Executive narratives around staff utilization to manage IITs vs. internal trials
    • Types of IIT studies supported by benchmark organizations
    • Executive narrative around the growing interest in certain types of studies
    • IIT leadership roles
    • Involvement of various functions during concept review
    • Involvement of various functions during protocol review
    • Involvement of various functions throughout IIT operational management
    • Involvement of various functions during IIT publication review

    II. Governance and SOPs with IITs

    • Level of position of the IIT operational team lead
    • Most challenging part of IIT structure and management
    • SOPs and impact of SOPs on investigator initiated trial process

    III. IIT Committee

    • Presence of an IIT committee that oversees the selection process within benchmarked companies
    • Functions represented on the IIT committee
    • Frequency of IIT review committee meeting
    • Role of MSLs in IIT management
    • Stage at which IIT committee allows the conversion of an IIT to a collaborative study
    • Approximate percentage of total number of approved IIT submissions belonging to each of the listed study types

    IV. Proposal Evaluation

    • Most important criteria when evaluating an IIT proposal
    • Reasons for automatically rejecting an IIT proposal

    V. Review Process in IIT

    • Top three approaches to increase the efficiency of IIT review
    • Use of tools to facilitate submission review, components of these tools
    • Review of concept proposals - on a rolling basis or within a submission window
    • Effectiveness of metrics used to measure IIT performance

    VI. Resource Allocation

    • Number of FTEs dedicated to IIT management, management of the entire process from submission to study activation and study close out
    • Time spent on IIT management
    • Time spent on IIT management – comparison with 2017 data
    • Dedicated IIT funding within benchmark companies; Total budget for IIT management in the last fiscal year ($USD), number of IITs included the total budget in the last fiscal year
    • Methods of budget forecasting for IIT programs
    • Functions providing financial support to IITs
    • Percentage of total IIT budget allocated to each of the listed areas
    • Allowable indirect cost rates (in %); Escalation process if IDC requests are higher than allowable rates, Limitations on the direct costs to which IDC is applied
    • Category of the budget request to which IDC is applied
    • Payment of fringe benefits on salary; Allowable percentage on salary, management of budgets with fringe benefits request in case of no fringe benefits on salary

    VII. Investigator Networking

    • In case of multiple investigators submitting similar proposals, whether benchmark organizations allow introducing these investigators to each other in case they may be interested in collaborating

    VIII. Payment Milestones

    • Determination of milestone payments for clinical IITs
    • Payment milestone used for IITs
    • What percentage of IITs generated publications in the last year?
    • Requirement of publication (abstract or peer review manuscript) as a condition for final milestone payment

    IX. Communication

    • Preferred channel for receiving IIT updates and its frequency
    • Extent of feedback provided by the IIT committee to investigators after the concept submission review

    X. Future Prospects

    • Anticipated trend regarding IIT funding over the next 24-36 months; Parameters used to invite investigators onsite to present on their study findings after their study is completed
    • Top challenges to the IIT management process
    • Plans to improve the IIT management process