A clinical trial is a research study conducted to evaluate the effects, efficacy, and safety of medical interventions, such as drugs, devices, therapies, or procedures, in humans. These trials are crucial for advancing medical knowledge and improving patient care. Clinical trials typically follow a structured protocol and are conducted in phases: 1. **Phase I**: Focuses on assessing the safety, dosage, and potential side effects of a new treatment in a small group of participants.
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A clinical trial is a research study that prospectively assigns people to an intervention to evaluate health-related outcomes. The intervention can be a medicine, procedure, device or behavioural approach. In a randomized controlled trial, random assignment creates comparison groups; blinding reduces some measurement and expectation effects. For example, comparing a new treatment with usual care requires a prespecified outcome and follow-up interval, not merely observing whether treated participants improve. A trial differs from an observational study, where investigators do not assign the exposure.[ref]
https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. NIH, The Basics: clinical trials and research phases