Transcript Branding 101 Presentation for CAC

Operationalizing
Compliance
Requirements in
Clinical Trials
University of Colorado
Denver | Anschutz Medical Campus
Presented at NCURA
Wednesday April 6, 2011
Hot Topics
• Regulatory (IRB) Role
• Clinical Trial Agreement (legal and
business issues/terms)
• Budget Negotiation
• PI/Clinician Perspective
• Conduct of Protocol
• Other considerations
Clinical Trial Summary
• Career Induced Attention Deficit DisorderCIADD
– Progressive neuropsychological disorder
– Pervasive at Academic Research Institutions
– Pater piling/hoarding
– Inability to stay on task and complete projects
– Incomplete e-mail syntax, headaches,
tremors, spontaneous verbal/emotional
outbursts
Clinical Trial Summary
• Progressing and unremitting
• >80% patients are completely debilitated within 5
years
• Current treatment-gabapentin and haloperidol
– Modest improvement to symptoms
– Slows disease progression in ~ 50% of patients
IM Pharma, Inc.
• IMP-1138
– Acts on the CNS
– Safe, well-tolerated in preclinical
and Phase I/IIa clinical studies
– Drug regimen:
• Double-blind, randomized, placebo-controlled 12month trial
• Open-label IMP-1138 for next 12 months
– Standard care counseling
– Monthly clinic visits
Institutional Review Board
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Research vs. Standard of Care
Vulnerable Populations
FDA vs. DHHS Regulations
Consent form
– Readability
– Consent Traps
• Biobanking
Clinical Trial Agreement
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Publications
Intellectual Property
Subject Injury Language
3rd Party Payor Language
Clinical Trial Agreement
• Indemnification
– Sponsor vs. Investigator-Initiated
• Law/Venue
• Contract Research Organization (CRO)
Budget Negotiation
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Payment schedule
Final payment terms
Upfront payment/Startup fees
IRB Payment
Screen Failure Payment
Invoiceable Items
Clinician Perspective
• Clinician/PI conflicted role
– Oversight of the patient’s care
– Moving science forward
– Funding
– Consent Process
• Navigating IRB/Sponsor requests
– Time Commitment
• Investigator Meetings
– Trusted Coordinator/PRA
– Consent form (exculpatory language)
Clinical-Conduct of Protocol
• Enrollment Requirements
– Start, deadline, numbers
• CRF Review/Monitor review
– Frequency and duration
• eCRF
• CRC and DM Time
• Billing compliance
Other Considerations
• Master Agreement-how much does it help?
• Template informed consent Language-bridge
the gap to ensure CTA and ICF match?
• Statement of Fees
• Long-term relationship between pharma and
university: a two-way street?
Thank you
University of Colorado
Denver