Best Practices in the Oversight and Management of Investigator Initiated Trials

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.

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

• 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.

Sr. No.	Topic	Slide No.
I.	Overview	pgs. 3-6
	Research Overview	pg. 4
	Universe of Learning	pgs. 5-6
II.	Key Findings and Insights	pgs. 7-9
III.	Activities and Responsibilities	pgs. 10-19
IV.	Governance and SOPs with IITs	pgs. 20-23
V.	IIT Committee	pgs. 24-30
VI.	Proposal Evaluation	pgs. 31-33
VII.	Review Process in IIT	pgs. 34-38
VIII.	Resource Allocation	pgs. 39-49
IX.	Investigator Networking	pgs. 50-51
X.	Payment Milestones	pgs. 52-55
XI.	Communication	pgs. 56-58
XII.	Future Prospects	pgs. 59-62
XIII.	Participant Demographics	pgs. 63-64
XIV.	About Best Practices, LLC	pg. 65

• 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

• 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

• 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

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

• 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

• 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

• 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

• 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

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

• 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