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Investigator Initiated Trials Management

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8	Info Graphics
37	Data Graphics
560+	Metrics
15	Narratives

Pages: 60

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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.

Benchmark Class
Study Snapshot
Key Findings
View TOC and List of Exhibits

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 Summary	pgs. 3-9
	Research Overview	pg. 3
	Participating Companies	pg. 4
	Key Findings	pgs. 5-9
II.	Activities and Responsibilities	pgs. 10-19
	Therapeutic Area Responsibility
	Functional Involvement and MSL’s Role
III.	Reporting and Governance	pgs. 20-29
	IIT Types, Structure and Leadership Level
	SOPs, IIT Process & Challenges
IV.	Resource Allocation	pgs. 30-40
	IIT Budget and Staffing
	IIT Committee Members & Review, Management
V.	Performance Assessment	pgs. 41-48
	Criteria for IIT Evaluation & Rejection
	IIT Performance Management & Auditing
VI.	Communication	pgs. 49-55
VII.	Study Participant Demographics	pgs. 56-58
VIII.	About Best Practices, LLC	pg. 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

Communication

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

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Investigator Initiated Trials Management

Benchmark Class

Study Snapshot

Key Findings

View TOC and List of Exhibits