“Clinical trial” means a systematic study of new drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological (including pharmacodynamics and pharmacokinetics) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug. The process of drug development can be broadly classified as pre-clinical and clinical. Pre-clinical refers to experimentation that occurs before it is given to human subjects; whereas, clinical refers to experimentation with humans. Within the realm of clinical research, clinical trials are classified into four phases: Discovery Phase, Pre-Clinical Phase, Clinical Phase and Commercial Phase.

This topic describes: Types of Clinical Trails (According to u.s NIH), Classification of Various phases of clinical trials, Distinctive features, Purpose, Study Design, Subjects involved, No. of subjects and Length of Studies.

Various phases of clinical trial

Also checkout: Full Clinical Research Notes Pharm.D Notes for Other Subjects