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Phase O Trials: Ethical Considerations

Phase O Trials: Ethical Considerations. Holly Taylor, PhD, MPH Department of Health Policy and Management Bloomberg School of Public Health Berman Institute of Bioethics Johns Hopkins University. Summary. Subject Understanding Respect for Persons Empirical Evidence from Phase I

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Phase O Trials: Ethical Considerations

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  1. Phase O Trials:Ethical Considerations Holly Taylor, PhD, MPH Department of Health Policy and Management Bloomberg School of Public Health Berman Institute of Bioethics Johns Hopkins University

  2. Summary • Subject Understanding • Respect for Persons • Empirical Evidence from Phase I • Patient Subject • Physician Investigator • Moving Forward • Voluntariness • Disclosure • Understanding

  3. Subject Understanding • Respect for Persons • Informed Consent • Elements of Consent • Threshold • Competence • Voluntariness • Informational • Disclosure • Understanding • Consent • Decision Source: Beauchamp & Childress (2001)

  4. 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

  5. Subject Understanding • Empirical Evidence from Phase I • Dynamic • Advice of and trust in physician motivating factors for patient subject enrollment

  6. Subject Understanding • Moving Forward • Voluntariness • Appreciate the ‘vulnerability’ of patients who are at end of life and exhausted all treatment options.

  7. 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

  8. Subject Understanding • Moving Forward • Understanding • Implementation of best practices regarding consent process • Assessment of patient understanding before and after participation

  9. Subject Understanding • Moving Forward • Commitment to evidence-based research practice • Apply knowledge to other phases of drug development

  10. IRB Risk Assessment: Do the Benefits Outweigh the Risks? Individual Individual Society Benefit Risk

  11. IRB Risk Assessment: Do the Benefits Outweigh the Risks? Intervention- related Intervention- related Society Benefit Risk

  12. IRB Risk Assessment: Do the Benefits Outweigh the Risks? Individual Society Individual Benefit Risk

  13. Summary • Subject Understanding • Respect for Persons • Empirical Evidence from Phase I • Patient Subject • Physician Investigator • Moving Forward • Voluntariness • Disclosure • Understanding

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