Understanding Clinical Trials

Clinical trials depend on people like you. Your participation is not only important to clinical research, but also provides the clinical data needed for medical advances to become available to the public. Clinical trials look at new ways to prevent, detect or treat disease or conditions. Clinical research also provides valuable information about how health and disease progress.

At Borland Groover we value our patients and strive to meet your care expectations through a delivery system based on compassionate, confidential care. Our commitment to providing excellent healthcare also involves conducting clinical research with the purpose of helping our patients live longer, healthier lives.

People choose to participate in clinical studies for a variety of reasons including: receiving the newest treatment, additional care and attention from the clinical trial staff, helping others, personal interest in research and playing an active role in their own health care. Research participants may be compensated for meals, travel costs, time and effort that they devote to a clinical trial.

Clinical studies have guidelines about who can participate. Factors that allow someone to take part in a clinical study are called “inclusion criteria.” Factors that do not allow participation are called “exclusion criteria.” These criteria are based on considerations such as: age, sex, disease and other medical conditions. The criteria are used to find appropriate people for the study, ensure their safety and to help researchers find needed information.

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and 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, monitor 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 closely with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided.

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. The participant then decides whether or not to sign the document. Informed consent is not a contract and the participant may withdraw from the trial at any time.

Benefits

• Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
  • Play an active role in their health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks

• All medical research involves some level of risk.
• Risks and benefits may be different depending on the study.
• The research team is required to tell you about known risks, benefits and available alternative health care options.

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, detailing 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.

People 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 you to discuss with your health care team. Some of the answers to these questions can be 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 experimental treatment being tested may be effective? Has it been tested before?
• What kinds of tests and experimental 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 experimental 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 experimental treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

• Plan ahead 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.