Clinical study

Clinical Study

A clinical study is a research investigation in which people volunteer to test new treatments, interventions, or tests as a means to prevent, detect, treat, or manage various diseases or medical conditions. Clinical studies are fundamental to the advancement of medical knowledge and the development of new therapies.

Types of Clinical Studies

Clinical studies can be broadly categorized into two types:

Clinical Trials

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker), is safe and effective in people.

• Phase I Trials: These trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects).
• Phase II Trials: The biomedical intervention is given to a larger group of people (e.g., several hundred) to see if it is effective and to further evaluate its safety.
• Phase III Trials: The intervention is given to large groups of people (e.g., several hundred to several thousand) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the intervention to be used safely.
• Phase IV Trials: These are post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

Observational Studies

Observational studies involve assessing 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 they are not assigned to specific interventions by the investigator.

• Cohort Studies: These studies follow a group of people over time to determine how certain factors affect rates of a certain outcome.
• Case-Control Studies: These studies compare people with a specific outcome of interest (cases) to people from the same population without that outcome (controls).
• Cross-Sectional Studies: These studies analyze data from a population, or a representative subset, at a specific point in time.

Ethical Considerations

Ethical considerations are paramount in clinical studies. The Declaration of Helsinki and the Belmont Report are key documents that outline ethical principles for conducting research involving human subjects. Informed consent is a critical component, ensuring that participants are fully aware of the study's nature, risks, and benefits before agreeing to participate.

Regulatory Oversight

Clinical studies are subject to rigorous regulatory oversight to ensure the safety and rights of participants. In the United States, the Food and Drug Administration (FDA) oversees clinical trials of drugs and devices. Institutional Review Boards (IRBs) review and approve study protocols to ensure ethical standards are met.

Also see

• Clinical trial
• Observational study
• Informed consent
• Declaration of Helsinki
• Belmont Report

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