BIOSTATISTICS IN CLINICAL RESEARCH: A REVIEW
Keywords:
Biostatisticians,, clinical research,, statistical analysis plan, sample size,, TLFs.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.
