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BIOSTATISTICS & RESEARCH METHODOLOGY WITH AN OVERVIEW ON CLINICAL RESEARCH

Abstract

Abhishek Kumar Yadav

Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug. Clinical Research is conducted in 4 Phases. Phase I trials - the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way. Phase II trials – the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects. Phase III trials - between 1000 and 5000 patients use statistics to analyze the results. If the results are favourable, the data is presented to the licensing authorities for a commercial licence. Phase IV trials - the medicine is make available to doctors, who start prescribing it & effects are monitored on thousands of patients to help identify any unforeseen side effects. The role of statics is to investigate proposed medical treatments, assessing benefits of competing therapies and establishing optimal treatment combination. Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. Selection of the proper statistical test depends on the type and number of variables and whether parametric conditions are met. Various methods include t-tests, analysis of variance, repeated measures ANOVA, linear regression, analysis of covariance, non-parametric tests, binomial tests, chi-square test, Fisher's exact test, McNamara’s test, Cochran-Mantel-Haenszel test, logistic regression, log-rank test, and Cox proportional hazards model. Bio statistical analysis is an important part of clinical trials because it allows researchers to determine whether or not their results were meaningful on a statistical level. Thus Biostatisticians are those who perform statistical programming, design, and analysis for clinical trial projects. Planning, coordinating and providing statistical analyses, summaries and reports of studies is also a part of their job profile. They are also responsible for New Drug Applications and Biological License Applications submissions

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