Clinical Trials Day

Clinical research enables researchers and doctors to find new and better ways to understand, detect, control and treat human diseases. A clinical research study is a way to find answers to difficult scientific or health questions. For example, a clinical study might be conducted to identify what causes people to get a disease (observational study) or test whether a new treatment, surgical procedure or lifestyle change can cure or prevent a disease from occurring (interventional study).

Some clinical research studies are purely observational. Although the subjects may be required to donate a blood specimen or undergo a diagnostic procedure, no treatment will be administered to them to try to change the course of their disease. In this type of study, data will be collected from the subjects through clinical testing or questionnaires. The data will be analyzed to try to determine what caused the disease or why some people are more likely to develop it than others. Blood is often collected to test for a genetic predisposition for the condition. Different types of data are collected to determine what other factors might have contributed to the disease. Examples of some of the types of data that might be collected for an observational clinical research study include family, medical, occupational and geographical history, ethnicity, toxicant exposure, diet and lifestyle.

If a clinical research study involves studying a drug, a new medical procedure or device, it is called a clinical trial. For example, a clinical trial may test the effectiveness of a new drug for treating diabetes or asthma. Many new medicines and drugs are found to work in the researcher’s lab, and to be safe and effective in animal tests. But drugs and devices must be proven to be safe and effective for people before they can be routinely used in people.

Informed consent is the process of learning the key facts about a clinical research study before you decide whether or not to participate. The facts include: why the research is being done, what the researchers want to accomplish, what will be done during the study and for how long, what risks are involved in the trial, what benefits can be expected from the study, and what other treatments are available. A written consent form will also tell you your rights as a research subjects, i.e. that you have the right to leave a study at any time. It will also describe how your privacy will be protected during the study. You will receive an informed consent document, given an opportunity to read it and ask any questions, and then asked to sign it. A copy of the form will then be given to you.

Yes. You can leave a clinical research study at any time. At the beginning of a study, you will be given information on whom to contact if you decide to withdraw. You should let the research team know why you are leaving a study.

Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Doctors, other health care providers, and other individuals can also sponsor clinical research.

Clinical studies can take place in many locations, including hospitals, universities, doctors’ offices, and community clinics. The location depends on who is conducting the study.

The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll.

In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:

• Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition
• Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
• Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
• Examining methods for identifying a condition or the risk factors for that condition
• Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness