Clinical trial participation is voluntary and open to anyone who meets certain guidelines set out in the research protocol. These guidelines are called inclusion and exclusion criteria and are often based on factors such as age, gender, type and stage of disease, previous medical treatments and other medical conditions. Inclusion and exclusion criteria help ensure the safety of participants.

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

Clinical trials are the best way of testing a new treatment, or of seeing whether one particular treatment works better than another. All clinical trials must be approved by a Victorian Human Research Ethics Committee before recruitment can begin. This approval process provides assurance to participants that their rights and any research benefits and risks have been carefully considered.

Benefits: Clinical trials enable eligible participants to

Play an active role in their own health care
Possibly gain access to new research treatments before they're widely available
Get expert medical care at leading health care facilities
Help others by contributing to medical research

Risks: There are risks to clinical trials

There may be unpleasant, serious or even life-threatening side effects to some experimental treatments
The experimental treatment may not be effective for the participant
The research protocol may require more of the participants time and attention than standard treatment would

What's a research protocol?

All clinical trials are carried out according to a protocol. A protocol is like an instruction manual for a clinical trial. Protocols are written by experts in their field to protect the safety of participants and to ensure the research question is being answered.

A protocol sets out who can participate in the trial, how long the trial will go for and how many visits to a clinic or hospital a participant will need to make. The protocol will also outline any tests to be carried out as part of the trial and give details of any medications to be taken as part of the research.

What are the different types of clinical trials?

Treatment trials: test experimental treatments, new combinations of medication, or new approaches to surgery or radiation therapy.
Prevention trials: look for ways to prevent disease in people who are disease-free, or to prevent a disease from returning. Prevention trials may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
Diagnostic trials: are done 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.
Supportive care trials: explore ways to improve comfort and quality of life for people with an illness.

What are the different phases of treatment clinical trials?

Treatment clinical trials are conducted in phases. A new treatment must start in a phase 1 trial and progress through the different phases before it can be made available to the public. The trials at each phase have a different purpose and help scientists answer different questions.

In Phase 1 trials, researchers test an experimental treatment for the first time in a small group of people (approximately 20) to asses its safety, to determine what is a safe dose and to identify any side effects.

In Phase 2 trials, the experimental treatment is given to a larger group of people (about 80) to see if it's effective against the illness or condition being studied and to further evaluate its safety.

In Phase 3 trials, the experimental treatment is given to an even larger group of people (hundreds, even thousands) to confirm its effectiveness, to monitor side effects and to compare it to commonly used treatments or current usual practice.

What is informed consent?

Informed consent is the process of learning about a clinical trial before deciding whether or not to participate. The research team will first give a detailed explanation of the study. If the participant's native language is not English, translation assistance can usually be provided. The research team then provides an informed consent document, which includes all of the information a potential participant should know about the clinical trial.

Those considering entering a clinical trial should read the informed consent document carefully and ask their doctor or a member of the research team to explain anything that's unclear. The participant then decides whether or not to sign the document and proceed with the trial. Informed consent is not a contract, and the participant may withdraw from the trial at any time and still receive the best available care.

What happens during a clinical trial?

Participants in a clinical trial work very closely with the research team which can include doctors, nurses, clinical research coordinators and other health care professionals.

At the beginning of a clinical trial, participants may be asked to have extra tests such as CT and bone scans to make sure they are eligible to participate. They're then guided through the trial by the research team who will monitor their progress carefully and organise any tests or investigations that are required as part of the trial. Some clinical trials involve more tests and hospital visits than the participant would normally have for their illness or condition.

What are side effects and adverse events?

Side effects are any undesirable outcomes from the experimental treatment and are often expected to occur. For example, hair loss is a known side effect of some types of chemotherapy. Other side effects of cancer treatment can include fatigue, headaches, nausea and skin irritation.

Adverse events are unexpeced medical problems that arise during treatment. Side effects and adverse events are monitored by research staff throughout a clinical trial and the treatment given to participants may be altered if they experience severe side effects or adverse events.

Will taking part in a clinical trial cost me money?

No more so than if you did not take part in a clinical trial. Any tests, medications or procedures that are part of a clinical trial and not part of standard care will be paid for by the sponsor of the trial. It's rare that people are paid to participate in clinical trials but sometimes money is provided to cover travel expenses.

What kind of preparation should a potential participant make for a meeting with the research coordinator or doctor?

Plan ahead and write down possible questions to ask.
Ask a friend or relative to come along for support. It's also a good idea to have someone there as a second set of ears when hearing new information for the first time and to hear responses to any questions.
Bring a tape recorder to record the discussion to replay later.

What should I consider before participating in a trial?

People should know as much as possible about the clinical trial before deciding to take part. Click here to download our list of questions to ask your doctor about participating in clinical trials.

Does a participant continue to see their General Practitioner while in a trial?

Yes. Most clinical trials provide short-term treatments related to a specific illness or condition, but do not provide extended or complete primary health care. In addition, by having the GP health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the trial treatments.

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

Yes. Participation in a clinical trial is completely voluntary and participants can choose to leave a clinical trial at any time, without even providing a reason. This will not change the relationship they have with their doctor and treating clinic, who will still receive the best possible care.

Do people involved in a trial get access to the results all the way through?

Results of a clinical trial are usually not published until the trial has finished. Some results may be released while the study is ongoing but this happens rarely. It can take a number of years for a research question to be completely answered.

For example, a trial may want to measure survival without any evidence of disease in women with a certain type of breast cancer at 5 years post-diagnosis. It will take time, sometimes years, to recruit the required number of participants. They are then monitored for 5 years and following that the research team has to analyse all of the data they have collected during that time. It would not be unusual for a trial such as that to take 8 years or more to publish any results.

Once published, all participants should have access to the results. Results may also be presented at scientific meetings.

Why are clinical trials registered?

The International Committee of Medical Journal Editors (ICJME) has established a requirement that all clinical trials are entered in a public registry before the onset of patient enrolment, as a condition of consideration for publication.

Rather than a single trial, it's usually a body of evidence, consisting of many clinical trials, that changes medical practice. When research sponsors or investigators conceal the presence of selected trials, possibly because of negative results, these studies can't influence the thinking of patients, clinicians, other researchers, and experts who write practice guidelines or decide on insurance-coverage policy. If all trials are registered in a public repository at their inception, every trial's existence is part of the public record and the many stakeholders in clinical research can explore the full range of clinical evidence.

The Victorian Cancer Trials Link database is not a clinical trial registry but provides links to several registries within the information about the trial.

Is there someone, other than a doctor, to talk to about being in a clinical trial?

The cancer nurses at Cancer Council Victoria's Cancer Information and Support Service can help potential participants put together a list of questions for their doctors when discussing clinical trials and treatment options. They can also provide general information about clinical trials. Call 13 11 20 to speak to a cancer nurse.

How can I find a clinical trial that is suitable for me?

Cancer Council Victoria has developed a unique resource called the Victorian Cancer Trials Link (VCTL). The VCTL is searchable database of all cancer clinical trials being conducted in Victoria and can be used by both consumers and clinicians.

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Updated: 25 Feb, 2009