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

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

• 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.

Sr. No.	Topic	Slide No.
I.	Overview	pgs. 3-5
	Research Overview	pg. 4
	Universe of Learning	pg. 5
II.	Key Findings and Insights	pgs. 6-8
III.	Activities and Responsibilities	pgs. 9-18
IV.	Governance and SOPs with IITs	pgs. 19-22
V.	IIT Committee	pgs. 23-28
VI.	Proposal Evaluation	pgs. 29-31
VII.	Review Process in IIT	pgs. 32-36
VIII.	Resource Allocation	pgs. 37-45
IX.	Investigator Networking	pgs. 46-47
X.	Payment Milestones	pgs. 48-51
XI.	Communication	pgs. 52-54
XII.	Future Prospects	pgs. 55-58
XIII.	Participant Demographics	pgs. 59-61
XIV.	About Best Practices, LLC	pg. 62

• 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

• 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

• 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

• 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
• 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

• 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

• 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

• 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

• 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

• 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