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Phase 1 tests safety in small groups of healthy volunteers or patients. Phase 2 explores dosing and early efficacy in dozens to hundreds. Phase 3 conf...
Why Randomization Matters in MedicineRandom assignment is the only way to guarantee, on average, that treatment groups are similar in both measured and unmeasured factors. Without it, con...
The Placebo Effect and Blinding in Clinical TrialsPlacebo controls and blinding protect trials from expectation effects on both patients and investigators. ORBITA showed why sham procedures matter eve...
Surrogate Endpoints: When Shortcuts MisleadSurrogate endpoints like bone density, PVC suppression, or HDL changes promise faster, smaller trials. Sometimes they work, as with LDL and blood pres...
How to Read a Clinical Trial PaperStart with the question and population: who was studied and does it match your patient. Check randomization, blinding, and allocation concealment. Loo...
Why So Many Promising Trials FailMost trials fail because the underlying hypothesis is wrong, the dose or timing is off, or the population is diluted. Heterogeneous diseases like hear...