Medical breakthroughs — and even cures — for some of the most pressing health concerns depend on patients’ participation in clinical research. Clinical research helps doctors and researchers learn more about disease and improve health care for people today and in the future.
A clinical research study engages human volunteers (also called study participants or subjects) in research that is intended to contribute to medical knowledge and/or collect information toward the commercialization of a new treatment. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.
Clinical trials evaluate the effects of a new or investigational intervention (e.g., a drug, device, or health behavior) on health outcomes, and may examine new ways to prevent, detect, or treat disease. Clinical trials may study:
- New drugs or combinations of drugs
- New surgical procedures
- New medical devices
- New ways to use existing treatments
- New ways to change behaviors to improve health
- New ways to improve the quality of life for people with acute or chronic illnesses.
In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions or procedures (which can include approved medical products such as drugs or devices) as part of their routine medical care, but participants are not typically assigned to specific interventions by the physician investigator (as in a clinical trial).