Clinical studies

A clinical study involves research using human volunteers (also known as participants) intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies. Clinical studies are part of clinical research and are at the heart of all medical advancements. They look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical studies is to determine if a new test or treatment works and is safe. Clinical studies can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

Types of Clinical Studies

Clinical Trials

In clinical trials, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet.

Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other.

Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).

• Phase I trials: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• Phase II trials: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
• Phase III trials: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• Phase IV trials: Studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.

Observational Studies

In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator.

Ethical Conduct

Clinical studies should follow ethical guidelines to protect the rights and welfare of the participants. These guidelines include obtaining informed consent from the participant or the participant's legal representative, ensuring that the benefits of participation outweigh the risks, and respecting the privacy and confidentiality of the participant's information.

See Also

• Randomized Controlled Trial
• Placebo
• Observational Study
• Informed Consent
• Phases of Clinical Trials
• Precision Medicine Intervention in Severe Asthma (PRISM) Clinical Study

References

Clinical studies Resources
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