A Practical Approach to Clinical Trials: Concepts and Methodologies

Abstract

Clinical trial is a research study that is conducted on human volunteers to collect safety and efficacy data for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). Clinical trial is intended to produce knowledge valuable for understanding human disease, preventing and treating illness and promoting health. Clinical trials can only be conducted after gathering satisfactory information on the quality and non-clinical safety of the product, and after taking Ethics Committee approval. Initially, these trials are conducted on small number of subjects. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multi-center trials in multiple countries. Clinical trials are used to test the safety and efficacy of new drugs and therapies on human volunteers. Today, such investigations are carried out using protocols that adhere to accepted standards of safety, patient care and data interpretation. However, history shows that patient welfare was not always such a high priority. Recently, clinical trials are facing several challenges, such as imperfect public understanding of clinical research, lack of interest in practitioners, and poor coordination between health management organizations and academic medical centers. So, there is a need to educate all practitioners about clinical research, and to stimulate their interest in clinical research careers. The aim of this review is to enlighten general public and practitioners about the facts and general details of clinical trials.