Vol. 7, Issue 7 (2018)
Key concepts of clinical trials and their regulations: A review
Buchepalli Ramakrishna, Brahmaiah Bonthagarala, MV Nagabhushanam, D Nagarjuna Reddy and G Ramakrishna
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are fastest and safest way to find treatment that work in people and way to improve health. Investigational trials determine whether experimental treatment or new ways of using known therapies are safe and effective under controlled environment. Observational trials address health issues in large groups of people or population in natural settings. Clinical trials aim to measure therapeutic effectiveness and constitute an important and highly specialized form of biological assay. In phase I pharmacokinetics, safety, gross effects are studied on human volunteers, by clinical pharmacologists. If the drug passes the test, it enters phase II testings, where pharmacokinetics, safety, therapeutic efficiency are studied on selected patients by clinical pharmacologist, if passes hundreds of selected patients are now studied, primarily for safety and therapeutic effectiveness by clinical investigators in phase III. If this is passed the drug is now approved and marketed. Even after marketing, physicians from various hospitals and clinics send their opinion about the drug, regarding ADR, efficacy in phase IV.
How to cite this article:
Buchepalli Ramakrishna, Brahmaiah Bonthagarala, MV Nagabhushanam, D Nagarjuna Reddy, G Ramakrishna. Key concepts of clinical trials and their regulations: A review. Pharma Innovation 2018;7(7):631-637.