The Lancet Handbook of Essential Concepts in Clinical Research

The Lancet Handbook of Essential Concepts in Clinical Research

By Kenneth Schulz, PhD, MBA, Vice President of Quantitative Sciences, Family Health International, Research Triangle Park, North Carolina, and Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, North Carolina, USA; and David A. Grimes, MD, Vice President of Biomedical Affairs, Family Health International, Research Triangle Park, North Carolina, and Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA


An overview of clinical research: the lay of the land.
Descriptive studies: what they can and cannot do.
Bias and causal associations in observational research.
Cohort studies: marching towards outcome.
Case-control studies: research in reverse.
Generation of allocation sequences in randomized trials: chance, not choice.
Allocation concealment in randomized trials: defending against deciphering.
Sample size slippages in randomized trials: exclusions and the lost and wayward.
Blinding in randomized trials: hiding who got what.
Uses and abuses of screening tests.
Unequal group sizes in randomized trials: guarding against guessing.
Sample size calculations in randomized trials: mandatory and mystical.
Compared to what? Finding controls for case-control studies.
Refining clinical diagnosis with likelihood ratios.
Multiplicity in randomized trials I: endpoints and treatments.
Multiplicity in randomized trials II: subgroup and interim analyses.