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Phase O Trials:Ethical Considerations
Holly Taylor, PhD, MPHDepartment of Health Policy and ManagementBloomberg School of Public HealthBerman Institute of Bioethics Johns Hopkins University
Summary
• Subject Understanding
– Respect for Persons
– Empirical Evidence from Phase I• Patient Subject• Physician Investigator
– Moving Forward• Voluntariness• Disclosure• Understanding
Subject Understanding
• Respect for Persons
– Informed Consent• Elements of Consent
– Threshold• Competence• Voluntariness
– Informational• Disclosure• Understanding
– Consent• Decision
Source: Beauchamp & Childress (2001)
Subject Understanding
• Empirical Evidence from Phase I
– Patient subject• Majority believe they understand trial but majority
unable to correctly state purpose and other details• Majority enroll with hope for direct medical benefit• Low refusal rates
– Physician Investigator• Overstate likelihood of benefit• Role of language in presentation of options
Subject Understanding
• Empirical Evidence from Phase I
– Dynamic• Advice of and trust in physician motivating factors for
patient subject enrollment
Subject Understanding
• Moving Forward
– Voluntariness• Appreciate the ‘vulnerability’ of patients who are at
end of life and exhausted all treatment options.
Subject Understanding
• Moving Forward
– Disclosure• No potential for direct medical benefit• Physical risks
– related to intervention– serial biopsies
• Benefits to future patients only• Potential effect on quality of life • Alternatives
– Phase I or II trials– Palliative care
Subject Understanding
• Moving Forward
– Understanding• Implementation of best practices regarding consent
process• Assessment of patient understanding before and
after participation
Subject Understanding
• Moving Forward
– Commitment to evidence-based research practice
– Apply knowledge to other phases of drug
development
Individual
RiskBenefit
Society
IRB Risk Assessment:Do the Benefits Outweigh the Risks?
Individual
Intervention-related
RiskBenefit
Society
IRB Risk Assessment:Do the Benefits Outweigh the Risks?
Intervention-related
Individual
RiskBenefit
Society
IRB Risk Assessment:Do the Benefits Outweigh the Risks?
Individual
Summary
• Subject Understanding
– Respect for Persons
– Empirical Evidence from Phase I• Patient Subject• Physician Investigator
– Moving Forward• Voluntariness• Disclosure• Understanding
