Journal of Clinical Trials
Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison.
Costs for clinical trials can range into the billions of dollars per approved drug. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.
Trials of drugs
Some clinical trials involve healthy subjects with no pre-existing medical conditions. Other clinical trials pertain to patients with specific health conditions who are willing to try an experimental treatment.
When participants are healthy volunteers who receive financial incentives, the goals are different than when the participants are sick. During dosing periods, study subjects typically remain under supervision for one to 40 nights.
Clinical trials are classified by the research objective created by the investigators.
In an observational study, the investigators observe the subjects and measure their outcomes. The researchers do not actively manage the study.
In an interventional study, the investigators give the research subjects an experimental drug, surgical procedure, use of a medical device, diagnostic or other intervention to compare the treated subjects with those receiving no treatment or the standard treatment. Then the researchers assess how the subjects' health changes.
Trials are classified by their purpose. After approval for human research is granted to the trial sponsor, the U.S. Food and Drug Administration (FDA) organizes and monitors the results of trials according to type:
Prevention trials look for ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include drugs, vitamins or other micronutrients, vaccines, or lifestyle changes.
Screening trials test for ways to identify certain diseases or health conditions.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Treatment trials test experimental drugs, new combinations of drugs, or new approaches to surgery or radiation therapy.
Quality of life trials (supportive care trials) evaluate how to improve comfort and quality of care for people with a chronic illness.
Genetic trials are conducted to assess the prediction accuracy of genetic disorders making a person more or less likely to develop a disease.
Epidemiological trials have the goal of identifying the general causes, patterns or control of diseases in large numbers of people.
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Journal of Clinical Trials