Discussion and questions Ethical issues of placebo controlled - - PowerPoint PPT Presentation

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Discussion and questions Ethical issues of placebo controlled - - PowerPoint PPT Presentation

Sep 04, 2023 449 likes •522 views

Discussion and questions Ethical issues of placebo controlled studies in type 1 SMA Use of palliative care in studies in type I SMA Discussion and questions Ethical issues of placebo controlled studies in type 1 SMA Use of

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SLIDE 1

Discussion and questions

  • Ethical issues of placebo controlled

studies in type 1 SMA

  • Use of palliative care in studies in type I

SMA

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SLIDE 2

Discussion and questions

  • Ethical issues of placebo controlled

studies in type 1 SMA

  • Use of palliative care in studies in type I

SMA

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SLIDE 3

Placebo Drug under investigation Effective drug

  • Provides natural history in the context of a trial
  • Limitations of natural history studies
  • When is a single arm study appropriate?
  • Convergence of multiple studies
  • Recruitment challenges
  • Impact on the field
  • Standard of care
  • Clinical Trial design
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SLIDE 4

Discussion and questions

  • Ethical issues of placebo controlled

studies in type 1 SMA

  • Use of palliative care in studies in type I

SMA

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SLIDE 5

SOC and Clinical Trials

Ethical quandary

Autonomy

Clinical Trial Efficiency

  • Allow parental decisions about palliative care
  • Yet support the participant for sufficient time to respond to

drug

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SLIDE 6

Decision of parents in the context of a trial Agreement of physicians

Palliative Care Reactive Measures

To implement:

– Respiratory measures

  • Non-invasive ventilation
  • Invasive ventilation
  • Tracheostomy

– Nutritional measures

  • Nasogastric tube
  • Gastrostomy tube

Proactive measures