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Operationalizing Compliance Requirements in Clinical TrialsUniversity of ColoradoDenver | Anschutz Medical CampusPresented 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 Disorder-CIADD– 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 12-month trial
• Open-label IMP-1138 for next 12 months
– Standard care counseling– Monthly clinic visits
Institutional Review Board
• Research vs. Standard of Care• Vulnerable Populations• FDA vs. DHHS Regulations• Consent form
– Readability– Consent Traps
• Biobanking
Clinical Trial Agreement
• 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
• 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?