Research
Clinical trials, also called clinical research, are studies that involve volunteers to test whether new treatments are safe and effective.
Clinical trials are essential to developing new treatments, which must first show positive results in laboratory or animal studies before human testing. Interventional trials test whether new or existing therapies are safe and effective under controlled conditions, while observational trials study health issues in large populations in natural settings. The FDA oversees most trials to protect participants and the public, and reviews the resulting data to decide whether a treatment should be approved.
Trials remain the safest and fastest way to confirm whether a treatment truly benefits patients, and they may give you access to a promising new therapy, often compared against a currently approved one.
If you’re considering a trial, talk with your doctor about the benefits and risks and whether you meet its eligibility requirements, since each trial sets its own. Before enrolling, the FDA requires you to read and sign an informed consent form explaining the study’s key facts, which you can review with your family and doctor. Make sure you understand everything before signing, and don’t hesitate to ask questions.
Phase I tests safety in a small group of 20 to 100 people, usually healthy volunteers. Researchers study how the body handles the treatment and what side effects appear at different doses.
Phase II tests whether the treatment works, in up to several hundred patients. Patients are often randomly assigned to receive either the new treatment or a standard treatment or placebo, without knowing which they’re getting.
Phase III confirms how well the treatment works and checks for side effects in several hundred to several thousand patients, often over several years. If successful, the company can apply for FDA approval.
Phase IV takes place after approval to track long-term safety and effectiveness and compare the treatment with others. These findings can lead to new restrictions or removal from the market.
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