Investigator Initiated Trials Management

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

• “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.

• 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

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

• 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

• 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

• 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

• 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