Rigorous clinical trials are necessary to move psychedelic research forward, ensuring safety and efficacy while moving toward formal regulatory approval.

“So I don't see it as a race between the decriminalization or legalization of these compounds versus their medical development.”

A study design should include pre-specified primary outcomes to prevent the bias inherent in multiple hypothesis testing.

“it's really important that when people are pre-registering studies they State what the primary outcome is and what the secondary outcomes are and typically a study that fails to meet its primary outcome will be deemed a null study even if it meets secondary outcomes”

Researchers currently lack actionable biological clocks that have sufficient clinical utility for human trials.

“I don't think anybody knows exactly how to do that yet including us but we're doing our best and learning as we go.”

He contends that two months of post-vaccination follow-up is sufficient to identify serious side effects.

“I was on a cdc conference call yesterday with a group of folks that are associated with the advisory committee for immunization practices and we collectively could not think of a serious side effect that was not picked up after two months so i'm optimistic that that would happen here as well”

Clinical trials in oncology frequently utilize surrogate endpoints like tumor shrinkage rather than focusing on endpoints that directly reflect patient longevity or quality of life.

“two-thirds of cancer drugs are being approved one-third i know they shrink tumors more than 30 in a fraction of people the other third i know they delay tumor growth by 20 and then the other third i know you live longer live better”