What will taking part in a clinical trial mean to you?

Protection for participants
There are a number of ways that participants are protected when they take part in a clinical trial. The drugs themselves are initially tested in the laboratory before they are tested on people. The first tests in people are in Phase 1 trials. (This is unless they have undergone Phase 0 testing where the drug is first tested in humans.) Phase 1 studies are conducted at centres with specialised monitoring facilities and the ability to carry out intensive surveillance. In most trials, the plan is reviewed by both a scientific review panel and an ethics committee before it gets final approval. For large multi-centre Phase 3 trials, a Data and Safety Monitoring Board supervises the trial. Many trials are also reviewed by a scientific review panel. 

The ethics committee is kept informed of important results during the trial. Before a person agrees to participate in a trial they must be given full information about the purpose of the trial and its risks and benefits. This process is called 'informed consent'. Your privacy is protected in trials. Participants can withdraw from a trial at any time. 

In a randomised trial there are generally two types of treatments being compared:

• the standard treatment (the best available treatment for your cancer)     
• the new trial treatment (the intervention treatment). 

You can't assume the new treatment is better than the standard treatment. That is why it is being tested in a trial. Even though there is this unknown aspect to the trial, there are advantages to taking part: 

• If you do not get the new treatment in the trial, you will receive the best known standard treatment. This may be as good as or better than the new treatment.
• If you are taking the new treatment, it might turn out that it is better than the standard treatment, and you might benefit.
• You can help in the future treatment of people with cancer.
• You might have more blood tests and scans and more visits to your cancer specialist and this closer monitoring might benefit you.

There is some risk with treatments being studied in a trial. It is important to remember that drugs tested in the trial have been tested in the laboratory before going to Phase 1 and 2 clinical trials. In Phase 3 trials more is known about the side effects of treatments so there is less risk than in Phase 1 and 2 trials. Even though the new treatment is still being tested, the research team will know a lot about the treatment. 

The possible drawbacks of being in a trial are:

• The new treatment may be less effective than standard care.
• Even if the new treatment is effective, it might not work for you.
• If you receive standard care in the trial, it might turn out that this is not as effective as the new treatment.
• You may experience unexpected side effects.
• You may need to travel to the hospital more often, which will take time and may cost money (although trials will generally cover the cost of any additional tests or treatments for you, and may cover travel and accommodation costs too).
• You will need to read a lot of information and sign paperwork.
• You may not hear the results of the trial, or you may see them in the media before being told. To avoid this, it is important to ask your cancer specialist for the results of the trial as soon as they become available.

You can withdraw from the trial at any time. It is not necessary to give a reason. You will not be disadvantaged if you do this. You will be able to receive the standard treatment, or the most appropriate treatment for you, when you withdraw from the trial.

Taking part in a clinical trial should not cost you more money than not taking part. Some of the tests and treatments that you receive in the trial are part of standard care. The costs of extra tests or treatments are covered by the trial organisers. Make sure this is covered in the document that you sign.

Participants might sometimes need extra visits to their cancer specialist. Some people may wish to travel to another hospital to participate in a clinical trial (for example, people living in rural areas). In most cases, travel and accommodation costs are paid for by participants. It is possible to ask your cancer specialist if there are ways to be reimbursed for travel and accommodation expenses. Social workers can often provide assistance with options for financial support. 

Financial assistance will vary depending on where you live in Australia so it is important to check what local support schemes are available for you.

Government travel assistance

There are a number of state government travel assistance schemes including:

• Isolated Patients Travel and Accommodation Scheme (IPTAAS) in NSW
• Patient Assisted Travel Schemes (PATS) in other states 
• Interstate Patient Travel and Assistance Scheme (IPTAS)  

These schemes subsidise travel and accommodation costs to assist people to access planned clinical care that is not available locally. These schemes do not currently cover travel to take part in a clinical trial.

Other forms of travel assistance

Some private health insurers provide travel and accommodation cover for their members who must travel a specified minimum distance to receive health care. Benefits vary across insurers. You must check with your insurer to see if costs to participate in a clinical trial are covered.  

A number of not-for-profit organisations - including volunteer organisations - provide free or subsidised transport to medical appointments. Further, there are various (but limited) accommodation facilities, which house people undergoing specialist treatment. Check the Cancer Council website in your state for a list of accommodation. Your social worker or GP can help you find out about organisations that may be able to assist you with financial and practical support during your cancer journey.

How can the results be accessed?

You will know how the trialed treatment has affected you individually, through results of your own tests. However, trials take a long time. It can take many years to recruit the numbers of participants needed for large Phase 3 trial. After the trial has finished, there is a follow-up period which can be up to 5 years or may be more in some cases. For this reason, the results of the trial that you took part in may not be available for a number of years. Sometimes, the data is analysed in an early report called an 'interim analysis'. This may give some helpful early results. It is important that your cancer specialist lets you know the clinical trial results as soon as they become available. However, it is possible that you will need to remind your cancer specialist to give you the results of the trial.

Publishing the results

It is important that the results of a trial, whether they are positive or negative, be published in medical journals. This is so that the cancer community can find out about important results so that treatment can improve for patients. Sometimes the results of trials are presented at meetings and conferences attended by doctors and nurses involved in cancer research and care, and reported in the media. Some people find this way of hearing results distressing and confusing.

How do you make sense of the results?

It is helpful to understand the language used by doctors to describe the results of clinical trials. The common terms used are:

• Response rate - how much of the cancer the treatment kills. If the cancer disappears for a period of time it is called a 'complete response'. If half of the cancer disappears it is called a 'partial response'. If it stays about the same size it is called 'stable disease.
• Duration of response - the time it takes for the cancer to come back or start growing again
• Disease progression - this is when the cancer continues to increase in size even when you are having treatment, or a new secondary cancer is found
• Disease free survival - the percentage of people who are alive and cancer free after a specified number of years (usually 5 years)
• Overall survival - the percentage of people who are alive, with or without cancer, after a specified number of years (usually 5 years)
• Median survival - the length of time after randomisation when half of the patients are still alive.