Clinical research refers to the comprehensive study of health and illness in humans. It is different from laboratory research. Clinical research requires people to volunteer to help us understand health and medicine, while laboratory research does not usually require people for their research. Clinical research is primarily of two types: observational studies and clinical trials.
Clinical research is important to improve knowledge about new treatments, diseases, etc., to be able to provide better patient care. Contact an expert for more info on clinical research at clinical research Falls Church today.
Types of clinical research
- Observational Studies: People are observed in a normal setting without interventions. Researchers collect data from people and analyze changes over time. These studies are done to identify new treatments, risks for different diseases, prevention methods, etc., that are further examined during clinical trials.
- Clinical Trials: These studies are also known as interventional studies. Clinical trials test medical interventions like new medicines, treatments, and devices in living people. These trials are the main way of discovering if a new treatment or medical device is safe and effective enough to be marketed. Clinical trials are mostly conducted in four phases.
Phases of clinical trial
Generally, the research of a new drug needs to get through multiple phases to be considered effective and safe. Each phase helps researchers learn about a drug’s risks and benefits.
- Phase 1 trial tests a new drug or treatment on a small group of around 20-80 people who are volunteers to determine the right dosage, if the drug is safe, and if there are any side effects.
- Phase 2 trial tests the same drug on a large group of around 100-300 people to determine if it is effective and continues to evaluate the safety of the drug. The people involved in this research generally have the condition that the drug is purposed to treat.
- Phase 3 trial tests if the new drug is more effective than the medicines already available in the medicine market. This phase involves more people (about a few thousand) to study further its safety and effectiveness on different populations with different dosages. Some of the volunteers are given an already-approved drug to compare its results with the new drug.
- Phase 4 trial is conducted after the drug is approved by the FDA. This phase looks for new information on the drug after giving it to an even larger population. This phase of the trial mainly evaluates the side effects of the drug that are not evident until a few years, so the drug is studied for a longer period of time in this phase.