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Are all Phase 1 trials done on healthy human guinea pigs. Why do we allow otherwise healthy people to be guinea pigs? Presumably there are patients who have the
by intrasight 11y ago
Are all Phase 1 trials done on healthy human guinea pigs. Why do we allow otherwise healthy people to be guinea pigs? Presumably there are patients who have the disease this drug targets.
- stan_rogers 11y agoParkinson's is a toughie - you don't really know what a patient is suffering from, just the syndrome they're exhibiting. I "have Parkinson's", by which I mean I have a series of symptoms that aren't related to any known purely-genetic disease (there are several, and I've been tested for all of them), tumors or structural issues in the brain (lived many a night in various scanning devices), are similar in general tone to those common to Parkinson's sufferers, and which respond well to treatments for Parkinson's. The syndrome itself, though, is a bit idiosyncratic, and may in fact be a constellation of similar diseases rather than a single disease. Diagnosis is still mostly a process of observation and elimination, despite what a few optimistic studies may have reported.
- jonlucc 11y agoYes, phase 1 is to ascertain if the drug is safe in healthy patients. These people opt in for these studies.
- icegreentea 11y agoPhase 1 is typically done to determine dosing and side effects. It's more difficult to get this information from unhealthy subjects - more confounding factors.