The decision to participate in a clinical trial is an important, personal decision. The following frequently asked questions may assist in helping you make the decision. Please feel free to contact the clinical research staff if you have any questions that are not covered below. Relevant contacts for the current clinical trials are listed under each clinical trial.

What is a clinical trial?

Clinical trials are biomedical or health-related research studies in humans. Studies are either interventional (where participants are given a treatment and the outcomes are recorded) or observational (where participants are just observed and their outcomes are measured by the investigators).

Who can participate in a clinical trial?

Clinical trials have set guidelines about who can participate. There are certain inclusion and exclusion criteria that define who can participate in a clinical trial. This is essential as it helps produce reliable and statistically significant results. Criteria are based on factors such as age, gender, medical history, family history and current medication. Some research studies seek participants with a particular illness or conditions that are to be studied, while others need healthy participants as “control” subjects. Most studies require both patients and healthy participants.

What happens during a clinical trial?

The clinical trial process depends on what kind of trial is being conducted. Doctors, nurses, researchers and other health care professionals are usually involved in the trial. They will check the health of the participants at the beginning of the trial, give specific instructions for participating throughout the trial, monitor the participant during and at the end of the trial, and often stay in touch after the trial is completed.

What is informed consent?

Before a patient decides whether or not to participate, they are given the key facts about the trial. This is known as informed consent and a patient must be fully aware of the benefits and risks involved in a trial before choosing whether or not to be involved. It is also a continuing process throughout the study. Informed consent is not a contract and the participant can withdraw from the trial at any time.

How is the safety of the participant protected?

There are ethical and legal codes that apply to clinical trials. The trial follows a carefully controlled study plan which details what researchers will do in the study. This plan must first be approved by the Princess Alexandra Hospital Human Research Ethics Committee. The Committee is an independent committee of physicians, a nurse, a lawyer, a pharmacist, a minister of religion, community members and others who ensure that a clinical trial is ethical, that the risks are as low as possible and the potential benefits are worthwhile. The Diamantina Institute also has a Human Ethics Committee at The University of Queensland that may also initially approve and periodically review the research. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, in scientific journals and to various government agencies. Individual participants' names will not be disclosed and will not be mentioned in any of these reports.