Third and last session of #psychedelics @NIH 🇺🇲 workshop starting now, looking at how to optimize clinical trials design and how to get these treatments approved 🧵
Starting with Ido @hartogsohn 🇮🇱 on psychedelic set and setting theory
Important Q ❓
Do we have an (excessively) costly and complicated drug regulation apparatus?
Now my friend @DrSureshMuthu, lead author of one of the most important papers of 2021 tandfonline.com/doi/full/10.10…, on how to improve clinical trial designs 🤓
The unblinding problem has been drawn ✍️
High unblinding in psychedelic trials
A paradox? 🙃
Possible treatment designs
Many biases. What was controlled in the end?
Great work and excellent talk @DrSureshMuthu 🇳🇿
Next @appelbap on Ethical issues and challenges for research and clinical use
Sexual abuse issues ⚠️
Steering the future through ethics
Next is Javier Muniz from @US_FDA 🇺🇲
Unique challenges
Psychotherapy and labeling
Important recommendations to reduce bias 🧐
Last panel now facing some hard questions:
How do we regulate this in safe and beneficial ways?
What else is needed and how will it unfold?
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