Biostatistics in Clinical Research: A Review

Abstract

Statistics is the discipline concerning collection, organizing, analyzing, interpretation and presentation of data as the basis for explanation, description and comparison. In clinical trials and in the drug development process, statistics play a key role, from trial design to protocol development. The credibility of a clinical trial can be upheld and cooperation between physicians and statisticians can be strengthened by providing a fundamental understanding of statistical issues. In any phase of clinical research, including trial design, development of procedures, data management and tracking, data processing, and reporting of clinical trials, biostatistics are involved. Statisticians also have roles in formulate hypothesis, develop statistical analysis plan (SAP), choosing the appropriate test, choose an apt sample size, data collection, perform the tests, generating TLGs (tables, listings, and graphs) and reporting the inferences. It is important that the rest of the research team recognizes the statistical approach suggested by the biostatistician, because statisticians can specialize in study designs, therapeutic areas and statistical methods.