ABSTRACT
Every novel drug undergoes various levels of testing to determine its safety, efficacy for treating the condition it is intended to treat, and the correct dosage and administration route before it reaches a patient. Clinical trials help in deciding the correct medical approach that works best for certain types of diseases or for a specific group of people. The implementation of clinical trials involves a rigorous approach based on scientific, statistical, ethical, and legal considerations. The general procedure for a new drug to be established as a therapeutic agent starts with the establishment of the maximum tolerated dose in humans in phase I, followed by pharmacodynamics and pharmacokinetic studies and an understanding of its therapeutic benefit in phase II. Comparison of the drug efficacy with an established therapeutic agent in a large population of volunteers is carried out in phase III, and finally postmarket evaluation for adverse reactions and effectiveness after administration to the general public is investigated in phase IV. The drug development and approval process has been defined and regulated by the Food and Drug Administration (FDA) where the safety and efficacy of the drug is the primary focus. The Center for Drug Evaluation and Research (CDER) works to evaluate new drugs before they enter the market for sale. In order to ensure the drug evaluation process to local and national standards of safety and ethics, regulatory bodies like institutional review boards (IRBs) and data and safety monitoring boards (DSMBs) review the process and protocol of clinical trials.
