The Regional Cancer Treatment Service (RCTS) has as strong focus on improving health outcomes for our community, through research and development. This service is involved with national and international clinical trials (studies) focused on enhancing cancer care.
If you are a patient in the Regional Cancer Treatment Services (RCTS) you may be asked by your doctor if you would like to participate in a clinical trial.
A clinical trial is a study that tests new and possibly better ways of improving people’s health. A clinical trial tries to answer particular scientific questions that will help decide how safe and effective a new promising treatment or investigation is compared to the current standard of care. In a nutshell, a clinical trial involves taking the best available treatment and/or practice and trying to improve it.
A well-designed and well-controlled trial is the fastest and safest route to find better treatments for people. It is the only reliable way to find out if a different treatment, chemotherapy or radiotherapy is better than that being used as the standard treatment.
A study may look at whether prevention, diagnosis or treatment is possible, is effective and is also safe. Most trials also look at ways of improving a person’s quality of life.
Clinical trials are usually the end stage of a very long process which often starts with an idea from researchers or from a promising laboratory result. It normally takes several years before the results of a trial are known and published. If the new treatment is proved better, it usually takes several more years before it becomes available or widely used. Clinical trials don’t stop when a treatment is shown to be more effective than the current treatment. Further trials may look at whether a different dose is better or whether it is better combined with other treatments. Some of the most effective treatments used today are the result of past clinical trials from the last 30 years. And the results of clinical trials today will improve treatment for people who develop cancer in the future.
In the Trials Unit there are a number of trial co-ordinators. They have either a nursing or allied health qualification/background and are responsible for the co-ordination of trials. They are responsible for the co-ordination of the trial. Each trial also has a Doctor, called the Principal Investigator, who is responsible for that trial at MidCentral District Health Board. The patient’s RCTS doctor is responsible for their treatment on the trial.
The Clinical Trials Unit is located in the Radiation Oncology Department on the first floor of the Palmerston North Hospital.
Phone numbers 06 350 8098 or 06 950 8099
Taking part in a clinical trial
Your doctor may ask you to consider taking part in a clinical trial. Alternatively, you may like to ask your doctor if there is a trial for which you would be suitable. All trials have strict criteria about who can take part. For instance, a patient may have to be a certain age, or have a certain stage of cancer before they can be included in a study. If they meet the study criteria, they can be included in the study and are considered “eligible”. Criteria are there to protect the patients and to ensure researchers are able to answer the study question.
Taking part in a study is voluntary. You may choose not to take part or may leave the study at any time and this will not affect your ongoing care.
If you have questions about taking part in a study or if you suffer a research-related injury talk to your doctor, or meet with the doctor who is in charge of the study at this institution.
Possible Questions for Your Doctor
Here are some questions which you may like to talk through with your doctor before deciding whether to take part in a clinical trial:
• What are my treatment options?
• What is the purpose of the trial?
• What are the side effects of the trial treatment compared to the standard treatment?
• What tests are involved?
• Will I have to be hospitalized?
• Where will I be treated?
• Will there be any financial cost to me?
• How long will the trial last?
• Will details of my case remain confidential?
Usually our unit participates in studies that are international and are therefore non-specific to Maori. However, the trial team ensures that study procedures and documentation are conducted in accordance with local regulatory requirements and thus that Articles Two and Three of the Treaty of Waitangi are respected in any dealings with Maori participants.
The study team recognizes the importance of information as tāonga and that knowledge belongs to tangata whenua and must not be removed or handed on without their express approval. We are aware that discussions must be appropriate for Maori participants and in particular we ensure that information is understood. Whanau are welcome during discussions with the patient about participation or during the course of the study.
The Maori Health Unit at Te Whare Rapuora are advised about every trial we conduct. They are available for advice and support at any stage during the study and a contact name and phone number will be found on the study’s Patient Information sheet. Their phone number is: 06 350 8210
A new treatment is very carefully tested long before it is offered to patients. It will only be considered for a study if it looks like it will be an improvement on the standard treatment and seems as safe as the standard treatment. Before they are conducted, Clinical trials must go through a number of reviews and processes to make sure they are as safe as possible and that they are ethically sound. They need to show that, within reason, they can be expected to benefit society without harming the subjects enrolled in the trial.
As a first step, the clinical trial must be approved by a number of independent scientists. The next step is for the trial to be approved by an ethics committee. No trial may be undertaken before it is approved by such a committee. In New Zealand this committee includes members of the public, researchers, health care professionals, Maori representatives, legal experts and spiritual leaders. The ethics committee makes sure people taking part in the trial are offered the best available treatment and that their rights and interests are protected. Once the trial is approved and operating, the ethics committee must be informed of trial progress and any changes to the trial plan. A trial plan cannot be changed without the re-approval of the ethics committee. Clinical trials usually have a data monitoring committee. This is an independent committee which keeps an eye on the trial progress, assesses interim results and ensures that the trial is safe. The committee may stop the trial if there are more side effects than is expected or if one treatment is clearly worse or better than the other. In addition, our clinical trials are run according to strict scientific national and international guidelines for conducting good clinical trials.
It is important to consider the risks and benefits of becoming involved in a clinical trial. The potential risks of participating in a clinical trial may be:
New treatments may have undesired effects, called “side-effects”, such as headaches or hair loss. Some of these may not be expected because there has been less experience with the new treatment.
The efficacy of new treatments may be unpredictable and, in some cases, they may even be less effective than the standard treatment.
You may be required to have extra tests and procedures that may be time consuming and can sometimes cause discomfort.
People take part in clinical trials for a number of reasons:
They may receive a new treatment before it becomes widely available to patients generally.
They will receive the best available treatment or a treatment that is thought to be as good as, or better than the current best available treatment.
They are very carefully and thoroughly monitored during and after treatment. The benefit of this extra attention is that any changes in their health may be detected and acted upon earlier than if they were not in a trial.
Participants may have a better outcome from their involvement in a study.
The results of the trial may advance medical knowledge by improving the general understanding of the disease and the best way to treat it and so benefit future patients. The idea of helping others is important to many trial participants.