Real-world evidence vs clinical trial requirements for psilocybin and MDMA

Question

1. What is the TGA's current position on the use of real-world evidence in the evaluation of new chemical entities such as psilocybin and MDMA? 2. Why does the TGA continue to require Phase 3 randomised controlled trials (RCTs) as the primary basis for registration, even where large-scale real-world evidence is becoming available? 3. Has the TGA assessed whether blinding limitations in psychedelic-assisted therapy trials materially affect the reliability of RCT outcomes? 4. What assessment has been made of the variability between clinical trial populations and real-world patient populations in this therapeutic area? 5. Why is registry-based real-world evidence not currently accepted as sufficient for registration decisions in this context?

Answer

Please see attached answer.

Documents

• Question with answer (PDF) (opens in a new tab)
• DHDA SQ26-002764.pdf (opens in a new tab)