Clinical trials are research studies that test new medical treatments, drugs, devices, or procedures in people to evaluate their safety, effectiveness, and potential side effects. They play a crucial role in advancing healthcare by providing evidence about how well interventions work and whether they are safe to use in the general population.
Focuses on safety and dosage. A small group of healthy volunteers (20-100) is given the treatment to assess its safety, determine as safe dosage range, and identify any side effects.
Tests effectiveness and further evaluates safety. A larger group (100-300 people) who have the condition being treated participates to see if the treatment works and how well it works.
Compares the new treatment to existing treatments (or a placebo). This phase involves a large group (1,000-3,000 people) and provides more comprehensive data on effectiveness, benefits, and side effects.
Happens after the treatment has been approved and marketed. It monitors long-term effects, effectiveness, and any rare side effects over time.
Researchers observe participants without providing a specific intervention to understand the effects of a condition or behavior
Participants receive the treatment or intervention being tested.
Before joining a clinical trial, participants must give informed consent, meaning they are fully educated about the trial’s purpose, procedures, risks, and benefits.
Many trials use random assignment to groups (treatment vs. placebo or standard care) and blinding (where participants or researchers do not know which group participants are in) to eliminate bias.
Clinical trials are closely monitored by regulatory bodies (like the FDA in the U.S.) and ethics committees to ensure the safety of participants and the integrity of the data collected.