Questions & Answers

2. Do all clinical trials carry risk?

There are risks to participating in some clinical trials. There may be unpleasant, serious or even life-threatening side effects to experimental treatment. The experimental treatment may not be effective for the participant. The research plan or protocol may require more of their time and attention than would the standard treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements. There are some clinical trials — quality-of-life trials — that pose little or no risk.

3. What mechanisms protect the safety of volunteers in medical research?

The ethical and legal guidelines of medical practice also apply to clinical trials. Most clinical research is conducted according to federal regulations, which contain built-in safeguards to protect the participants. The trial follows a carefully controlled protocol — a study plan which explains what the researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals and to various government agencies.

4. If an individual agrees to participate in research, does that mean that he or she is committed for the entire length of the study?

No. An individual can withdrawal from a clinical trial at any time. It is important for the individual to let the researchers know the reason why they are leaving the study.

5. Who sponsors clinical trials?

Clinical trials are sponsored or funded by various organizations or individuals, such as physicians, medical institutions, foundations, voluntary groups and pharmaceutical companies. Federal or governmental agencies, such as the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs also sponsor clinical trials. Trials can take place in a variety of locations — hospitals, universities, doctors’ offices or community clinics.

6. What are the different types of clinical trials?

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These studies may include medicines, vaccines, vitamins, minerals or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. Screening trials look for the best way to initially detect certain diseases or health conditions.
Quality-of-life trials (or supportive care trials) look at ways to improve comfort and the quality of life for individuals with a certain ongoing illness.

7. Why are some people reluctant to volunteer for clinical research?

Some individuals are reluctant to volunteer to participate in clinical trials because in the past there were not always strict ethical, medical and legal guidelines in place to protect the safety of the volunteers. Others are reluctant because they know more about the risks and less about the potential benefits of participating in clinical research. Lastly, some people do not realize that by participating in clinical research they are helping researchers to learn about new potential treatments or procedures.

8. If your primary care physician does not offer you a clinical trial, what is the best way to find one?

Access to information on available clinical trials is available online, or through teaching hospitals or medical centers.

9. Who pays for medical research?

Medical research is paid for by grants which can be funded through governmental agencies, such as the National Institutes of Health and the Department of Defense, private foundations, pharmaceutical companies and medical institutions.