Ethical Considerations Ethical Considerations Associated with Investigator Associated with Investigator Payments & Patient Recruitment Payments & Patient Recruitment Ginger Clasby - EVP, Business Development Ginger Clasby - EVP, Business Development Promedica International Promedica International Costa Mesa, CA Costa Mesa, CA 714-799-1617 x 25 714-799-1617 x 25 [email protected][email protected]
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Ethical Considerations Associated with Investigator Payments & Patient Recruitment Ginger Clasby - EVP, Business Development Promedica International Costa.
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Ethical Considerations Associated Ethical Considerations Associated with Investigator Payments & Patient with Investigator Payments & Patient RecruitmentRecruitment
Ginger Clasby - EVP, Business DevelopmentGinger Clasby - EVP, Business DevelopmentPromedica InternationalPromedica International
Costa Mesa, CACosta Mesa, CA714-799-1617 x 25714-799-1617 x 25
Fast Track Systems: Industry Study Cost Trends, October 2003
And SoIn the Rush to Enroll…
• Subject disqualification criteria may be overlooked
• Subjects may not be given full disclosure regarding trial objectives
• Subjects may not be given full disclosure regarding associated risks
• Subjects may be rushed to participate (without given time to think it over)
Investigator ManagementFDA’s Toolbox
• Investigator Agreement – Form 1572• Financial Disclosure by Clinical Investigators• FDA Bioresearch Monitoring Program – Clinical Sites,
Sponsors, IRBs• Application of sanctions in association with violative
behaviors
BUT -
FDA does not have authority to review financial agreements
Investigator ManagementSponsor’s Toolbox
• Appropriate financial agreements• Formal investigator training programs• Study monitoring activities• Internal auditing program• Investigator termination from study
Investigator ManagementInvestigator Agreement – FDA Form 1572
• Commits to conduct study in accordance with protocol, FDA regulations & IRB conditions
• Commits to ensure informed consent requirements are met for all subjects (including controls)
• Commits to ensure that IRB reviews & approves study initially & on a continuing basis
Disregard to terms of agreement may be considered a criminal offense
• Applies to FDA-directed marketing applications only• No financial arrangements where study outcome may
affect investigator compensation• Investigator has no proprietary interest in tested
product • Investigator has no significant equity interest in
company• Investigator has not received significant payments of
other sorts
Investigator ManagementFDA Bioresearch Monitoring Program
• Comprehensive program of on-site inspections & data audits to monitor all aspects of conduct & reporting of FDA-regulated research
• Inspections typically include clinical investigators, IRBs, sponsor &/or CRO
Investigator ManagementFDA Sanctions
• Exclusion of questionable quality or integrity data• Restriction of parties corrupting process through
misconduct of malfeasance• Notification to affected parties to implement corrective
action
Investigator ManagementInvestigator Training Programs by Sponsor
• Provide detailed training on protocol implementation, study-related documentation & GCP
• Provide periodic training throughout study based on protocol or procedural amendments
• Training should be documented
Investigator ManagementStudy Monitoring Activities by Sponsor
• Perform study initiation visits• Perform interim study visits at appropriate intervals• Perform appropriate study data review to ID protocol
deviations, data inconsistencies, unreported safety events
• Review IRB submissions & responses
Get technicalFill in the blanks
Don’t be intimidatedAddress nonconformities appropriately
Investigator ManagementInternal Audits by Sponsor
• Perform interim site audits by trained auditors uninvolved in study
Be suspicious
Expect fraud
Investigator ManagementInvestigator Termination by Sponsor
• Terminate shipment of investigational product• Terminate investigator participation in study• Report investigator to FDA
The Role of the IRB
• Responsible for subject rights & welfare May insist on documentation of GCP training
• Reviews/approves study protocol & consent documents
• Reviews/approves most subject recruitment materials
• Reviews periodic study progress reports
• Reviews serious adverse event reports
21 CFR 50.25Consent Document Must Include
• Study involves “research”; explains research purpose• Known risks/benefits• Alternative treatments or procedures• Extent to which confidentiality will be maintained• Compensation & medical tx available in event of injury
or illness• Contact(s) to discuss study/subject rights• Participation is voluntary
21 CFR 50.25Add’l Consent Document Language
• Tx may involve unforeseeable risks• Anticipated circumstances when participation may be
terminated w/o regard to consent• Additional costs to subject for participation• Consequences associated with withdrawal of consent• Commitment to provide info on significant new findings
during study that may affect willingness to participate • Approximate # of subjects involved
Subject Recruitment ProgramsWANTED – Study Subjects NOW!
• Study websites
• Call centers
• Professional referrals
• Community outreach
• In-office awareness materials
• Direct to patient media advertising – newspaper, radio, TV, bulletin boards, posters, flyers, etc.
• Financial compensation
Subject Recruitment ProgramsPrint Recruitment Advertising Should Include
• Name & address of investigator or research facility• Condition under study or purpose of research• Summary of criteria used to determine study eligibility• Brief list of participation benefits (including cash)• Time or other commitment required of participants• Location of research & who to contact for further
• Payment amount & schedule must be approved by IRB• Payment amount should be reasonable – not coercive• Payment schedule should accrue - not contingent on
study completion
IRB Review of Subject Recruitment MaterialsProhibited Practices
• Coercive language– “New treatment”– “Free medical treatment”– “Make $100!”
• Stated or implied certainty of favorable outcome• Claims of safety or effectiveness • Claims of equivalence/superiority to other products
Integrity In Corporate PracticesWhat Industry Can Do
• Be thoughtful about patient eligibility criteria• Be realistic with respect to enrollment timetable• Provide appropriate investigator training & oversight• Follow-up promptly & appropriately on complaints