Fundamentals of Clinical Trials¶
Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials. Springer.
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3 citations across 3 artifacts.
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Primes¶
- Control Sample
- In clinical research it is placebo arms, standard-of-care comparators, and crossover designs in which each subject serves as their own control across periods.
This sourceStandard reference on control arms in clinical trials — placebo, standard-of-care, and crossover (within-subject) designs.
- In clinical research it is placebo arms, standard-of-care comparators, and crossover designs in which each subject serves as their own control across periods.
- Counterfactual Subtraction
- A pharmaceutical phase-III trial reports that a drug reduced 30-day mortality by 4 percentage points.
This sourceStandard clinical-trials methodology text on placebo-controlled design, where the placebo arm is the constructed counterfactual baseline and the randomisation-plus-blinding assumption licenses subtracting it to obtain the treatment effect (e.g., a placebo-subtracted mortality difference).
- A pharmaceutical phase-III trial reports that a drug reduced 30-day mortality by 4 percentage points.
- Empty Set
- In medicine it is the disease-free baseline and the placebo arm — "no detectable virus" being a structural state, not a missing reading.
This sourceEstablishes the control/placebo arm and the baseline assessment as defined reference states against which the intervention's effect is measured — a structural disease-free/no-treatment baseline, not a missing reading.
- In medicine it is the disease-free baseline and the placebo arm — "no detectable virus" being a structural state, not a missing reading.
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