Definition of clinical trial

The term "clinical trial" refers to a systematic and controlled experimental study that evaluates the safety, efficacy, and optimal dosage of a potential new drug, diagnostic test, or medical device on human subjects. The term originated from the clinical setting, where doctors provide medical care and treatment to patients. In the context of medical research, a clinical trial tests and compares the effectiveness of the new treatment or intervention against a current standard of care or a placebo, under carefully monitored and rigorous conditions. The results of clinical trials are critical in determining whether a new drug or therapy is effective, safe, and worthy of further clinical and regulatory approval for widespread use by healthcare providers. The history of clinical trials can be traced back over a century, with the first clinical trials conducted to evaluate the safety and efficacy of vaccines in the late 1800s. However, the modern concept and regulatory framework of clinical trials emerged in the mid-20th century, particularly after the introduction of the US Food and Drug Administration (FDA) regulatory pathways that require the submission of clinical trial data as a requirement for drug approval. The need for well-designed and robust clinical trials to support regulatory approval of new drugs and medical products continues to grow in present times, as there is an increasing demand for innovative and effective treatments for diseases and health conditions that pose significant medical, economic, and social burdens. Therefore, clinical trials continue to play a critical role in advancing our understanding of the safety, efficacy, and potential benefits and risks of new drugs and diagnostic tests, as well as in shaping the future of healthcare and medical research.