What are clinical trials?

ClinicalTrials.gov describe clinical trials (also called interventional studies) as research studies in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes.


As nia.nih.gov explains, before the U.S. Food and Drug Administration (FDA) approves a clinical trial, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA approves the intervention to be tested in humans.

Who can participate?

Clinical trials have specific guidelines about who can participate. People can enroll or not in a study based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Are clinical trials safe?

The safety of our patients is our priority. The ethical and legal codes that govern medical practice also apply to clinical trials, and most clinical research is federally regulated with built-in safeguards to protect participants.

What to expect?

The process depends on the kind of trial being conducted (phases I to IV). The research team includes doctors, nurses, and other healthcare professionals. Providers check patients at the beginning of the trial, give specific instructions for participating, monitor their performance during the trial, and follow up after the study is completed.

What are the four phases
of clinical trials?

Clinical trials advance through four phases to test a treatment, find an appropriate dosage and look for side effects. If researchers find a drug or other intervention safe and effective after the first three phases, the U.S. Food and Drug Administration (FDA) approves it for clinical use and continues monitoring its effects.

Phase I trial: Tests an experimental treatment on a small group of often healthy people to judge its safety and side effects and to find the correct drug dosage.

Phase II trial: While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people with a certain disease or condition. These trials also continue to study safety, including short-term side effects.

Phase III trial: Gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.

Phase IV trial: This is the final phase for drugs or devices. It takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, in a diverse population.

Source: nia.nih.gov

Should I continue with my regular treatment while enrolling in a study?

Yes. However, speaking with the doctor about your situation is crucial to ensure treatments and medications are consistent with the protocol.

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