15 Dec What Is Clinical Research?
Clinical research is medical research where people volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose, and understand human disease. Clinical research includes trials that test new treatments and therapies as well as long-term natural history studies, which provide valuable information about how disease and health progress.
Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.
Phase 1 Clinical Trials
Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
Phase 2 Clinical Trials
The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3 Clinical Trials
The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase 4 Clinical Trials
Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.
Below are different types of clinical studies:
- Treatment Research – generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.
- Prevention Research – looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Diagnostic Research – refers to the practice of looking for better ways to identify a particular disorder or condition.
- Screening Research – aims to find the best ways to detect certain disorders or health conditions.
- Quality of Life – Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.
- Genetic studies – aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up.
- Epidemiological studies – seek to identify the patterns, causes, and control of disorders in groups of people.
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