FAQs

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What is a clinical trial?

A clinical trial is a scientific study, or an organised test of medicines and new treatment options involving patient and non-patient human volunteers. Clinical trials confirm whether medicines are safe and effective before they can be introduced as new treatments for a particular disease or condition.

Are all clinical trials the same?

There are four different types of clinical trials, each one associated with a different phase in the development of a new medicine or treatment:

Phase 1: Determines the safety of the medicine, how it works and how well it is tolerated in small groups of people
Phase 2: Determines the effectiveness of the medicine and further evaluate the safety in a larger group of people
Phase 3: Determines the effectiveness, monitors side-effects and compares it to commonly used treatments in large groups of people
Phase 4: Post marketing studies reflect additional information including the drugs risks, benefits and optimal use
Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments at no cost before they are widely available, receive extensive medical care associated with the trial and help others by contributing to medical research.

What happens in a clinical trial?

A clinical trial team includes doctors, nurses and other health professionals who carefully follow the protocol or plan of the trial. They check the health of the participant at the start of the trial, give specific instructions for participating in the trial, monitor the participant through the trial and stay in touch after the trial is completed.

What is informed consent?

Informed consent is the process of learning the key facts about the clinical trial before deciding whether to participate. Doctors and nurses involved in the trial explain the details of the study and provide an informed consent document that outlines the study purpose, duration, required procedures, risks and benefits and key contacts. The patient 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.

What are the benefits and risks of participating in a trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments at no cost before they are widely available, receive extensive medical care associated with the trial and help others by contributing to medical research.

There are risks to clinical trials; there may be unpleasant, serious or even life threatening side effects to experimental treatments. The treatment may not be effective for the participant. The protocol or plan may require more of their time and attention, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are adverse reactions?

Adverse reactions are undesired actions or side-effects of the experimental drug or treatment. They may include headache, nausea, hair loss, skin irritation or other physical problems.

What should people consider before participating in a clinical trial?

People should know as much as possible about the clinical trial and feel comfortable asking members of the trial team questions about the trial, the care expected and why the researchers believe the experimental treatment being tested might be effective.

What is a protocol?

The protocol is a study plan on which all trials are based. The plan is designed to safeguard the health of the participants as well as answer any specific research questions. The protocol describes the types of people who are eligible to participate in the trial, the schedule of tests, procedures, medication and dosage and the duration of the trial.

What is a placebo?

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 effectiveness of the experimental treatment.

What is a control or control group?

A control is the standard to which experimental observations are compared. 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.

Can a participant leave a clinical trial after it has begun?

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.

What happens with the results?

As well as being reviewed by government authorities such as the Therapeutic Goods Administration, the results of a clinical trial may be reported in the medical press. The results are published so that doctors can make scientifically valid assessments of the risks and benefits of a new medicine. Although the results are published, nothing that identifies individual patients will be released. All details of a clinical trial participant's treatment are kept confidential and patient anonymity is assured.

How to cross refer?

The ALLG actively supports c​ross referral from clinicians at neighbouring hospital sites to clinicians located at a site where the clinical trial is open. Cross referral assists with increasing recruitment to the trial, and the benefit is that it also provides access to new treatment options. If you are a patient wanting to participate in a trial that is open at another hospital then please speak to your doctor to organise the referral.