This manuscript is an introduction to the design and planning of clinical research. Study designs are described and special emphasis is given to writing a protocol of a clinical trial. Sample selection and recruitment, variable measurement, randomization, follow up, statistical analysis, sample size and bias are covered.
This introduction to the design and planning of clinical research covers the theoretical background of practical issues. The refinement of a research question, the searching and critically appraising the literature and management of references are discussed. Ethical concerns are raised throughout the development of the study protocol. Study designs are described and special emphasis is given to writing a protocol of a clinical trial. Sample selection and recruitment, variable measurement, randomization, follow up, statistical analysis, sample size and bias are covered. Tips on how to successfully write and publish the research report are provided.