About Clinical Research
In a clinical trial, 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.
What are clinical studies?
Clinical studies are research studies in which real people participate as volunteers. Clinical research studies are a means of improving our understanding of disease, such as in observational studies, or developing new treatments and medications for diseases and conditions. Some clinical trials evaluate the effects of a biomedical or behavioral intervention on health outcomes. There are strict rules for clinical trials, which are monitored by the National Institutes of Health for the trials it funds, and the U.S. Food and Drug Administration (FDA) more broadly.
Before the FDA approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
Why should I participate in a clinical study?
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations.
What are Phase 1, Phase 2 and Phase 3 studies?
Phase 1 studies are used to learn the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects.
Phase 2 studies evaluate the efficacy of new drugs at various doses, the safety of said treatments and dosage specifications. Phase 3 studies evaluate safety and efficacy in a larger set of patients. Results are often used for marketing approval. In cancer research, product approvals can occur with Phase 1b or 2b studies of sufficient size that demonstrate safety and efficacy.