Clinical trial

A Clinical trial is a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. These trials are primarily conducted to determine the safety and effectiveness of new drugs, devices, diagnostic products, and treatment regimens intended for human use.

File:AI & ML in clinical trials.jpg

AI & ML in clinical trials

Types

• Clinical trials can be categorized into:
• Observational studies: Where researchers observe the participants without intervention.
• Interventional studies: Where researchers apply an intervention and measure its effect on the participants.
• Interventional studies are further divided into phases:
• Phase I trials: The new drug or treatment is tested in a small group for safety and dosage.
• Phase II trials: The drug or treatment is given to a larger group to further evaluate its safety and efficacy.
• Phase III trials: The drug or treatment is given to a large group to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
• Phase IV trials: Post marketing studies, which are conducted after a drug or treatment has been approved for use by the FDA.

Clinical Trial Participant Receives Injection (34033294061)

Procedure

Participants in a clinical trial may receive interventions such as medical products like drugs or devices, or procedures managed by the research team. Some participants may instead receive a placebo or other treatments as a control for comparison.

Ethics and Regulations

Clinical trials are regulated by health authorities and ethics committees. Informed consent from participants is a fundamental requirement in all clinical trials.

See Also

• Placebo
• Informed consent
• Epidemiology
• FDA approval

References

• "What Are Clinical Trials?". National Institutes of Health.
• "Learn About Clinical Studies". ClinicalTrials.gov.

External Links

Clinical Trials - MedlinePlus Clinical Trials - National Cancer Institute

Clinical trial Resources
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