4 ms·

Quick summary of the meaning of Phases in medical trials: Phase 0: exploration of effectiveness Phase I: is the treatment safe? Phase II: does the treatment

Quick summary of the meaning of Phases in medical trials: Phase 0: exploration of effectiveness Phase I: is the treatment safe? Phase II: does the treatment work? Phase III: is the treatment better than existing alternatives? Phase IV: After approval, monitor the long term effects of the treatment.

caycep 7y ago
I think also w/ increasing phase, the n sample size of the trial increases so the fisherian statistic has more "power" and more practitioners trust the study results...
lucb1e 7y ago
Just to be clear, which of these phases is the "clinical trials" stage? Are all of them clinical trails and we're starting at zero now? (Not that Roman numerals have zero, by the way :).) The dictionary says clinical trials are about "safety and effectiveness" so I guess that is indeed early phases?
- Wohlf 7y ago
  I may be wrong, but I think they are all different forms of clinical trials.
- herodotus 7y ago
  NIH Definition of a Clinical Trial: "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." A phase 1 clinical trial is used to determine safety (including dosage) and involves far fewer people than a stage III clinical trial. For Biotech startups, the companies value usually increases with each successfully completed trial. Conversely, the cost of conducting a trail also increases at each stage.
Gatsky 7y ago
Phase I is more “what is the highest dose that can be given safely?”
Alex3917 7y ago
More like: Phase I: Will this treatment immediately kill people? Phase II: Does this methodology seem like the right methodology to show some sort of result in larger trials? Phase III: Does the treatment work better than some type of placebo for at least a few weeks without causing obvious and unjustifiable harms during those few weeks. Phase IV: Let's shift our marketing budget into R&D so that we can claim to be unprofitable to congress.
- sszz 7y ago
  This is a super pessimistic and misleading description of phase 2 & 3 trials; actual efficacious drugs do come out of the FDA review process. Many phase 3 trials are against standard of care rather than placebo and many are longer than a few weeks, particularly for treatments where efficacy is hard to prove.
  - ozfive 7y ago
    Or take a long time to prove such as against cancer.
  - Alex3917 7y ago
    > Many phase 3 trials are against standard of care rather than placebo and many are longer than a few weeks Yeah but they (usually) don't have to be tested against the existing standard of care, or tested longer than a few weeks. So really it's misleading to claim that Phase III trials guarantee anything other than the extremely minimal standard of safety and efficacy that they actually guarantee.

caycep 7y ago

I think also w/ increasing phase, the n sample size of the trial increases so the fisherian statistic has more "power" and more practitioners trust the study results...

lucb1e 7y ago

Just to be clear, which of these phases is the "clinical trials" stage? Are all of them clinical trails and we're starting at zero now? (Not that Roman numerals have zero, by the way :).) The dictionary says clinical trials are about "safety and effectiveness" so I guess that is indeed early phases?

Wohlf 7y ago
I may be wrong, but I think they are all different forms of clinical trials.
herodotus 7y ago
NIH Definition of a Clinical Trial: "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." A phase 1 clinical trial is used to determine safety (including dosage) and involves far fewer people than a stage III clinical trial. For Biotech startups, the companies value usually increases with each successfully completed trial. Conversely, the cost of conducting a trail also increases at each stage.

Gatsky 7y ago

Phase I is more “what is the highest dose that can be given safely?”

Alex3917 7y ago

More like: Phase I: Will this treatment immediately kill people? Phase II: Does this methodology seem like the right methodology to show some sort of result in larger trials? Phase III: Does the treatment work better than some type of placebo for at least a few weeks without causing obvious and unjustifiable harms during those few weeks. Phase IV: Let's shift our marketing budget into R&D so that we can claim to be unprofitable to congress.

sszz 7y ago
This is a super pessimistic and misleading description of phase 2 & 3 trials; actual efficacious drugs do come out of the FDA review process. Many phase 3 trials are against standard of care rather than placebo and many are longer than a few weeks, particularly for treatments where efficacy is hard to prove.
- ozfive 7y ago
  Or take a long time to prove such as against cancer.
- Alex3917 7y ago
  > Many phase 3 trials are against standard of care rather than placebo and many are longer than a few weeks Yeah but they (usually) don't have to be tested against the existing standard of care, or tested longer than a few weeks. So really it's misleading to claim that Phase III trials guarantee anything other than the extremely minimal standard of safety and efficacy that they actually guarantee.