Other studies are looking for healthy participants. Some research studies seek participants who have the illnesses or conditions that will be studied. What information will be gathered about the participantsĬlinical studies have standards outlining who can participate, called eligibility criteria, which are listed in the protocol.The schedule of tests, procedures or drugs and their dosages.Who may participate in the study (the eligibility criteria).The protocol is designed to answer specific research questions as well as safeguard the health of participants. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.Ī clinical study is conducted according to a research plan known as the protocol. These will be described in the informed consent document for a particular trial. Many trials require participants to undergo additional procedures, tests and assessments based on the study protocol. (For trials approved by institutional review boards (IRB), the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.) Most trials involve some risk of harm or injury to the participant, although it may not be more than the risks related to routine medical care or disease progression. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative or diagnostic products or interventions.Ĭlinical trials provide the basis for the development and marketing of new drugs, biological products and medical devices. Participating in a clinical study contributes to medical knowledge. For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health. Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.
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Note: Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through an expanded access program. These phases are defined by the Food and Drug Administration (FDA). For 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. The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful or the same as available alternatives (including no intervention). Some clinical trials compare interventions that are already available to each other. These interventions may be medical products, such as drugs or devices, procedures or changes to participants’ behavior, for example, diet.Ĭlinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or no intervention. In a clinical trial (also called an interventional study), 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 and observational studies. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge.
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