Abstract

Abhimanyu, Aaditya Soni, Akash Kurmi, Aakash Patel and Dr. Vivek Jain*

ABSTRACT

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. Statistics is a major tool in pharmacological research that is used to sum up experimental data in terms of central tendency like mean or median and variance like standard deviation, standard error of the mean, confidence interval or range but more importantly it authorize us to managing hypothesis testing. It is the science that helps in control medical uncertains. It is consist of different steps like generation of hypothesis, collection of data and importance of statistical analysis in medical reasearches and experimental pharmacologyClinical 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. 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.