Designing clinical research

Sect. I. Basic ingredients

Getting started: the anatomy and physiology of clinical research

Conceiving the research question and developing the study plan

Choosing the study subjects: specification, sampling, and recruitment

Planning the measurements: precision, accuracy, and validity

Getting ready to estimate sample size: hypotheses and underlying principles

Estimating sample size and power: applications and examples

Sect. II. Study designs

Designing cross-sectional and cohort studies

Designing case-control studies

Enhancing casual inference in observational studies

Designing a randomized blinded trial

Alternative clinical trial designs and implementation issues

Designing studies of medical tests

Research using existing data

Sect. III. Implementation

Addressing ethical issues

Designing questionnaires, interviews, and online surveys

Data management

Implementing the study and quality control

Community and international studies

Writing a proposal for funding research.