Participant Information

Clinical trials are considered to be health-related research studies in human beings that follow a pre-defined protocol. All clinical trials have guidelines about who can participate. Using inclusion and exclusion criteria is an important principle of medical research that helps to produce reliable results. The criterion is usually based on factors including age, the type and stage of a disease, previous treatment history and other medical conditions. Participants must qualify for the study before joining a clinical trial. 

A clinical trial team consists of doctors, research coordinators, social workers, nurses and other health care professionals. They check and monitor participants throughout the duration of the trial. Some trials may require more tests and doctors’ visits than usual for an illness or condition. The participants work with a research team for all types of trials. Clinical trial participation is the most successful when the protocol is followed carefully with frequent contact with the research staff.  

Informed consent is the process of learning the important facts about a clinical trial before deciding whether or not to participate. Doctors or research coordinators involved in the trial will explain the details about the study and help a person decide whether or not to participate.
The research team provides an informed consent document that includes the details of the study, procedures and key contacts. All risks and potential benefits are explained in the informed consent document. The informed consent document is not a contract and the participant may withdraw from the trial at any time.

You should know as much as possible about the clinical trial and feel comfortable asking the members of the healthcare team questions about it, the care expected while in a trial, and the cost of the trial. Asking the following questions can be helpful for any participant to discuss with the healthcare team. Many of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with the current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working? Will results of the trial be provided to me?
• Who will be in charge of my care?

Side effects are any undesirable effects of drugs or treatment.  Some negative effects may include headaches, nausea, increased risk of infection, or other physical problems. If the trial is an experimental treatment, it must be evaluated for both immediate and long-term side effects. 

Well-designed and properly executed clinical trials are the best treatment approach for eligible participants to:

• Have an active role in their own healthcare
• Obtain access to new research treatments before they are widely available
• Obtain expert medical care at leading healthcare facilities
• Help others by contributing to medical research

Below are the risks to participating in a clinical trial:

• There may be unpleasant or serious side effects
• The treatment may not be effective for the participant
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what 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. Individual participants' names will remain secret and will not be mentioned in these reports.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Yes. A participant may leave a clinical trial at any time.  If you leave a clinical trial you will be returned to standard medical treatment and will receive the appropriate medical care. The participant should let the research team know when and the reasons why for leaving the study. 

Researchers usually come up with the ideas for clinical trials. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most encouraging results are moved into clinical trials. During a trial, more information is gained about an experimental treatment, its risks and how well it may or may not work.
Clinical trials are typically sponsored or funded by a variety of organizations or individuals including doctors, medical institutions, foundations, voluntary groups, and pharmaceutical companies as well as federal agencies such as the National Institutes of Health, the Department of Defense, and the Department of Veteran’s Affairs. Trials can take place in a variety of locations, such as hospitals, college campuses, doctors’ offices, or community clinics.

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.

A protocol is a study plan on which all clinical trials are based. This plan is designed to safeguard the health of the participants and answer specific research questions. A protocol describes what types of people may participate in the trial; procedures, medications and dosages; the length of the study and the test schedule. Participants in a clinical trial that follows a protocol are seen regularly by the research staff to monitor their and determine the safety and effectiveness of their treatment.

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.