Common Questions, Answered

Clinical studies involve research using human volunteers (also called participants). The purpose of clinical studies is to develop new and better ways to treat patients. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.

Clinical trials are conducted to collect data regarding the safety and efficacy of new drugs and devices and usually occur after extensive testing in the laboratory. Drugs and devices must submit to three phases of clinical trial testing before being considered for approval by the Food and Drug Administration (FDA) and available to consumers. These phases test the safety of drugs, how the drugs are absorbed and cleared from the body, how much drug is needed to be therapeutic, and the subsequent side effects. Typically, the clinical trial has two groups: one group that receives the study drug or device, and another group that receives a placebo (not the real drug) or the usual treatment. The participants and the research team are usually “blinded,” which means that they do not know which group the participant is in — though this information can be revealed if necessary. Approved drugs and devices may submit for a fourth phase to review the long-term effectiveness and impact on a patient’s life and to compare it to similar drugs on the market.

Observational studies collect information to assess how participants or groups do with standard therapies, such as drugs, devices, activities, or diets prescribed as part of their routine medical care.

Other types of research include health services, behavioral, survey, specimen, pharmacokinetics (how drugs are absorbed and cleared from the body), and pharmacodynamics (how much drug is needed to be therapeutic and the subsequent side effects). For more information about clinical studies and the phases or stages of testing that new drugs or devices must go through to obtain approval by the FDA, go toCenterWatch.com or ClinicalTrials.gov.

The Institutional Review Board, or IRB for short, is made up of research professionals and community members (i.e. non-research professionals) and review research study proposals prior to allowing research to begin to assure protection of all human subjects in research projects.

It is your right to step away from the study at any time, should you choose to do so!

Informed consent is the process of providing you with key information about a research study before you decide whether to accept the offer to take part. The process of informed consent continues throughout the study. To help you decide whether to take part, members of the research team explain the details of the study. If you do not understand English, a translator or interpreter may be provided. The research team provides an informed consent document that includes details about the study, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The informed consent document also explains risks and potential benefits. You can then decide whether to sign the document. Taking part in a clinical trial is voluntary and you can leave the study at any time.

Only through clinical research can we gain insights and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.