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Products & Services Medical Affairs Clinical Trials

Best Practices in the Oversight and Management of Investigator Initiated Trials in CNS Therapeutic Area

ID: POP-340


Features:

12 Info Graphics

34 Data Graphics

370+ Metrics

20 Narratives


Pages: 62


Published: 2021


Delivery Format: Shipped


 

License Options:


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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
As the number of investigator initiated trial (IIT) submissions continues to rise for CNS drug candidates, it has become a critical operational area for most CNS manufacturers.

Forward-looking 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 conducted this benchmarking research to provide a detailed roadmap for improving IIT management within CNS companies, capturing critical metrics and insights on IIT management team staffing, budget, and communication. This report also identifies the top challenges and future improvements to IIT management process for CNS treatments.

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


Companies Profiled:
Allergan; Blue Earth Diagnostics; EMD Serono; Gedeon Richter ; Guerbet; Ipsen; Jazz Pharmaceuticals; Lundbeck; Merck; Novartis; Sage Therapeutics; Sanofi; Solidfarma

Study Snapshot

Best Practices, LLC engaged 17 leaders from 13 bio-pharmaceutical companies offering CNS products through a benchmarking survey. Nearly 90% of the benchmark partners 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.

  • Engagement:
    • MSLs are the bridge connecting sponsors and investigators: MSLs act as the “bridge” connecting sponsors and investigators, facilitate engagement with them as well as provide updates and clarifications throughout the study process.
    • Most IIT submissions occur in an online setting: More than 40% of companies use tools like online portals, trackers and database tools to facilitate submission review.
Table of Contents

Sr. No.
Topic
Slide No.
I.
Overviewpgs. 3-5
Research Overviewpg. 4
Universe of Learningpg. 5
II.
Key Findings and Insightspgs. 6-8
III.
Activities and Responsibilitiespgs. 9-18
IV.
Governance and SOPs with IITspgs. 19-22
V.
IIT Committeepgs. 23-28
VI.
Proposal Evaluationpgs. 29-31
VII.
Review Process in IITpgs. 32-36
VIII.
Resource Allocationpgs. 37-45
IX.
Investigator Networkingpgs. 46-47
X.
Payment Milestonespgs. 48-51
XI.
Communicationpgs. 52-54
XII.
Future Prospectspgs. 55-58
XIII.
Participant Demographicspgs. 59-61
XIV.
About Best Practices, LLCpg. 62

    List of Charts & Exhibits

    I. Activities and Responsibilities

    • Presence of a dedicated IIT management department within CNS companies
    • Executive narratives around staff utilization to manage IITs vs. internal trials
    • Types of IIT studies supported by CNS organizations
    • Executive narrative around the growing interest in certain types of studies
    • IIT leadership roles within CNS companies
    • 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

    • Job level of the IIT operational team lead within CNS companies
    • 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 CNS companies
    • Functions represented on the IIT committee
    • Frequency of IIT review committee meetings
    • Role of medical science liaisons (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
    • Tools used to facilitate submission review, components of these tools
    • Review of concept proposals - on a rolling basis or within a submission window
    • Effectiveness of various metrics used to measure IIT performance

    VI. Resource Allocation

    • Number of FTEs dedicated to IIT management within CNS companies, FTE management of the entire process from submission to study activation and study close out
    • Time spent on IIT management within CNS companies
    • Dedicated IIT funding within benchmark companies; Total budget for IIT management in the last fiscal year ($USD), number of IITs included in 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 CNS 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
    • Percentage of IIT generated publications in the last year; Requirement of publication (abstract or peer review manuscript) as a condition for final milestone payment

    IX. Communication

    • Preferred channels for receiving IIT updates and its frequency of IIT updates
    • 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 within CNS companies
    • Plans to improve the IIT management process within CNS companies