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?

Thank youUniversity of ColoradoDenver