Frequently Asked Questions

Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. All clinical trials have guidelines about who can participate. A specific criteria for each individual study is an important principle of medical research that helps to produce reliable results. These criteria are based on factors such as:

• Age
• Gender
• Type and stage of a disease
• Previous treatment history
• Other medical conditions

It is important to note that the criteria is not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. All criteria help ensure that researchers will be able to answer the questions they plan to study.

The specific clinical trial process depends on the type of trial being conducted. The clinical trial team includes doctors and nurses as well as other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitors the participant carefully during the trial and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with the research team one on one. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

Clinical trials that are well designed and well executed are the best approach for eligible participants to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Help others by contributing to medical research.

The risks to clinical trials:

• There may be unpleasant, serious or even life-threatening side effects to treatment.
• 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.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate.

The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document as well.

The consent is updated throughout the study to provide any updates about the study to include any new side effects, timelines, effectiveness, additional visits or additional procedures, this is a continuing process throughout the study to provide information for participants.

The consent is also a document to help someone decide whether to participate or not based on the requirements from the participant.

At the screening visit the doctors and nurses involved in the trial explain the details of the study and answer any questions you may have. The participant then decides whether to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

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 that 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 remain secret, and are never mentioned in these reports.

Side effects are any undesired actions or effects of a drug or treatment. Any known side effect is included in the informed consent form, reviewed before the study begins. Negative or adverse effects may include headache, nausea, hair loss, skin irritation or other physical problems and vary depending on the medication/or medical device. Experimental treatments must be evaluated for both immediate and long-term side effects.

Participants should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some 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 my 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 trials be provided to me?
• Who will be in charge of my care?

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. Consider making the following preparations:

• Plan and write down possible questions to ask.
• Ask a friend or relative to come along for support and to hear the responses to the questions.
• Bring a tape recorder to record the discussion to replay later.

do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. The trial of a new treatment builds a much clearer picture of its risks and its effectiveness.

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies and medical device companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD) and the Department of Veterans Affairs (VA). Trials can take place in a variety of locations, such as dedicated clinical research sites, hospitals, universities, doctors’ offices or community clinics.

The protocol is the study plan on which a clinical trial is based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

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 treatment effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or 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.

Treatment trials test new treatments, new combinations of drugs, new medical devices, 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 approaches may include medicines, vaccines, vitamins and minerals or lifestyle changes. Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition. Screening trials test the best way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.