The protocol is designed to answer specific research questions and safeguard the health of participants. Or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigatorįor example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.Ī clinical study is conducted according to a research plan known as the protocol. Participants may receive interventions (which can include medical products such as drugs or devices) In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. More information on expanded access from the FDA.
#Research studies trial
Some people who are not eligible to participate in a clinical trial may be able to getĮxperimental drugs or devices outside of a clinical trial through expanded access. Phases are defined by the Food and Drug Administration (FDA). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.įor example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.Ĭlinical trials used in drug development are sometimes described by phase. It is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). When a new product or approach is being studied, Some clinical trials compare interventions that are already available to each other. Placebo that contains no active ingredients, or to no intervention. These interventions may be medical products, such as drugs or devices procedures or changes to participants' behavior, such as diet.Ĭlinical trials may compare a new medical approach to a standard one that is already available, to a In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.Ĭ includes both interventional and observational studies. Who Can Participate in a Clinical Study?Ī clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.Reasons for Conducting Clinical Studies.Why Should I Register and Submit Results?.
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