About Clinical Studies
Medical care differ from Clinical research trials.
Your doctor diagnoses and treats your present conditions or illness. During clinical research trials, the researchers are trying to collect new information that will help in the advance of medical care for people in the future.
Epocrates Medical & Research Center conducts pharmaceutical research studies including phases II-IV.
- Phase 2: includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
- Phase 2/Phase 3: for trials that are a combination of phases 2 and 3.
- Phase 3: includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
- Phase 4: studies of FDA-approved drugs to delineate additional information including the drug’s risks, benefits, and optimal use.
Nature of the investigation.
- Interventional: studies in which subjects are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. Researchers learn if a new test or treatment works and is safe, during clinical trials .The subjects are then followed and biomedical and/or health outcomes are assessed. Treatments studied in clinical trials might be new drugs or new combinations of drugs, or new ways to use existing treatments.
- Observational: studies in which subjects are observed and/or health outcomes are assessed in pre-defined groups of patients. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the researcher does not assign specific interventions (for example, no treatment is given) to affect the subjects’ outcome.