Effective Functioning of Clinical Trials in a Site: Challenges and Recommendations

Abstract

Clinical trials are studies conducted to determine whether a new treatment or drug is safe to use and to measure its efficacy. Some medications are brand-new, such as the COVID-19 vaccination COVISHIELD from Oxford University and AstraZeneca and COVAXIN from Bharat Biotech, which is an indigenous project. Some medicines are created based on non-patent formulations or expired patent licenses. Companies like Serum Institute of India develop the latter from existing formulations. This type of drug development may arise as an alternative in efficacy or competition in price for existing drugs on the market. For a drug to be used as a treatment, the founder of the medicine will be the sponsor that provides funding to the sites through a contract research organization. Once a site is selected, the study will commence. Volunteers will participate in the entire process, and they will be informed about their progress and any adverse events during the study. Based on the results, the efficacy of the medicine will be evaluated, and it will be brought to market as a commercial product.