INFORMATION FOR PARTICIPANTS

Clinical studies are research studies in which real people participate as volunteers. Clinical research studies are a means of improving our understanding of disease, such as in observational studies, or developing new treatments and medications for diseases and conditions, such as clinical trials, which are evaluating the effects of a biomedical or behavioral intervention on health outcomes. Clinical trials can look at:

• New drugs or new combinations of drugs
• New ways of doing surgery
• New medical devices
• New ways to use existing treatments
• New ways to change behaviors to improve health
• New ways to improve the quality of life for people with acute or chronic illnesses.

The goal of the study is to determine if these treatment, prevention, and behavior approaches are safe and effective.

A volunteer subject with no known significant health problems who participates in research to test a new drug, device, or intervention is known as a “healthy volunteer” or “Clinical Research Volunteer.”

Research procedures with these volunteers are designed to develop new knowledge, not to provide direct benefit to study participants.

Clinical research volunteers have always played a vital role in medical research. Healthy volunteers are important for several reasons: When developing a new technique such as a blood test or imaging device, clinical research volunteers to help define the limits of “normal.”

Phase I studies are used to learn the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase I studies typically offer little or no benefit to the volunteer subjects.

Phase II studies involve a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase II study.

Phase III studies compare the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition.

Phase IV studies (sometimes known as “post-marketing” or “surveillance” studies) gathers additional information about an approved drug’s side effects. In some cases the FDA requires a Phase IV study be conducted after drug approval.

The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:

• The Protocol Review Process
• Informed Consent Procedures

Protocol review. All clinical research protocols must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.

Informed consent. Your participation in any research project is voluntary.

• For every study in which you intend to participate, you will receive a document that explains the study in straightforward language.
• A member of the research team will discuss the protocol with you, explain its details, and answer your questions.
• Reading and understanding the protocol is your responsibility.
• You may discuss the protocol with family and friends.
• You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment.
• At any time after signing the protocol, you are free to change your mind and decide not to participate further.

Absolutely.

Everyone who joins a clinical trial has the right to change their mind at any time and withdraw their participation. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor who referred you to the research project.

You should not ever feel like you are required to participate in a clinical trial. If you feel that you have been pressured into participating in a clinical research project, you should contact the IRB listed in the informed consent form and tell them.

ClinicalTrials.Gov allows you to search for a clinical trial based on condition or disease, the name of the drug, the name of an investigator, and geography.

The National Institutes of Health offers many different resources in addition to clinicaltrials.gov to find a research trial on their website, “NIH Clinical Trials and You”.

The National Cancer Institute offers help in finding NCI-supported clinical trials.

Many local hospitals and major academic medical centers also offer the opportunity to participate in clinical research.