What Are Clinical Trials?

Clinical trials are prospective biomedical or behavioral research studies conducted on human participants. They aim to gather specific information about the safety and effectiveness of interventions such as drugs, treatments, therapies, medical devices, and behavioral interventions. These trials follow a well-defined protocol and are categorized into phases to assess the intervention's impact.
Phase I trials involve a small group of participants and primarily focus on evaluating the intervention's safety and determining appropriate dosages. Phase II trials include a larger group of participants and further evaluate the intervention's safety and preliminary effectiveness. Phase III trials involve an even larger population and compare the intervention's effectiveness against standard treatments or placebos.

Once regulatory approval is obtained, Phase IV trials may be conducted to monitor the intervention's long-term safety and effectiveness in larger populations. These trials provide valuable real-world data and insights.

Clinical trials are conducted after satisfactory preclinical studies, which involve laboratory experiments and studies on animals, have been completed. Ethical considerations are paramount, with independent ethics committees reviewing and approving study protocols to protect participant rights and well-being.

Clinical trials play a crucial role in advancing medical knowledge, improving patient care, and supporting the development of new therapies. They contribute to evidence-based decision-making in healthcare and help save lives.