A clinical research study helps researchers and doctors find new or better ways to understand, detect, control, and treat human diseases. For example, a clinical research study might be conducted to identify what causes people to get a disease or test whether a new treatment, surgical procedure, or lifestyle change can cure or prevent a disease.
Clinical studies provide many benefits to you.
What are the benefits if I participate?
The benefits depend on the particular study in which you participate. The largest benefit, by far, is that you are helping others with similar conditions by contributing to health research. Other benefits may include:
- Modifying your lifestyle for the better.
- Obtaining medical care.
- Taking an active role in your own health care.
- Gaining access to new treatments that are not available to the general public.
Who can participate in a clinical research study?
All clinical research studies have guidelines, called inclusion/exclusion criteria, that determine who can participate. These guidelines are based on factors such as age, type of disease, medical history, current medical condition, and exposure history. These criteria are used to identify appropriate participants and keep them safe, as well as ensure researchers will be able to answer the questions being asked.
What is a clinical research study?
Clinical research studies are studies involving people that are aimed at evaluating new ways to prevent, detect, diagnose, or treat disease. They are the main way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people. Other clinical research studies test ways to prevent a health problem or find a disease early, sometimes before there are symptoms. A clinical research study may also look at how to make life better for people living with a life-threatening disease or a chronic health problem.
What is the difference between an observational clinical research study and a clinical trial?
Some clinical research studies are purely observational. Although the volunteers may be required to donate a blood specimen or undergo a diagnostic procedure, no treatment will be given to change the course of their disease. In this type of study, data will be collected from the volunteers through clinical testing or questionnaires. The data will be analyzed 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. Examples of some of the types of data that maybe collected for an observational clinical research study include family, medical, occupational and geographical history, ethnicity, toxicant exposure, diet, and lifestyle.
A clinical trial is a clinical research study that involves studying a drug, new medical procedure, or device. For example, a clinical trial may test the effectiveness of a new drug for treating diabetes or asthma. Many new drugs are found to be effective in animal tests done in a research lab. However, drugs, procedures, and devices must be proven to be safe and effective for people, before they can be routinely used in people. That is where volunteers in clinical trials come in.
What are the risks of participating in a clinical research study?
There is risk in all clinical research. The informed consent process allows you to learn the facts about a clinical research study, before you decide 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, what benefits can be expected, and what other treatments are available. A written consent form will explain your rights as a research participant, and describe how your privacy will be protected during the study.
Where can I find out more about clinical research and studies for specific conditions?
Further information can be found at the following websites.
- Understanding Clinical Studies
Comprehensive information about participating in clinical trials, including how they work, what volunteers should know, benefits and risks, and how volunteers are protected.
- Search the Studies at NIH
Database of all clinical studies being conducted at the NIH Clinical Center in Bethesda, Maryland. Search by diagnosis, sign, symptom, key words, or phrases.
- ClinicalTrials.gov
A comprehensive database of about 5,700 current clinical studies sponsored by the federal government and the pharmaceutical industry. Search by disease, treatment, sponsor, or keyword.
- Cancer.gov
Search the National Cancer Institute database of more than 1,800 active cancer clinical trials. You can perform a broad search, such as breast cancer, or narrow your search by specifying other criteria, like type of trial or location.