MDHB News

Clinical Trials

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. Whether you have been asked or not, you may want to know more about clinical trials and how they are carried out in our Clinical Trials Unit.

Contact Clinical Trials

Palmerston North Hospital nurse listening to a patient's heart beat with a stethoscope

Common Questions

The sort of questions people most often ask appear below. Click on a questions and information will appear which will try to answer that question.

Tell me about the Clinical Trials Unit?
What staff make up the trial team?
Where is the unit?
What are its aims?
What types of trials are offered?
How do I contact the Clinical Trials Unit?
How can I take part in a Clinical trial?
What is a Clinical Trial?
Why have Clinical trials?
Are Clinical trials safe?
Why do people enter Clinical trials?
What are the risks and benefits of being in a clinical trial?
What are some features of Clinical trials?

The three phases
Trial protocol
Patient consent
Randomization
Blinding and Placebos
Quality of life

What are my rights as a participant?
Who can answer my questions or concerns about a study or about my rights?
What considerations are given to Maori participants?
What other questions should I ask?
What Internet sites are useful?

Tell me about the Clinical Trials Unit?

What staff make up the trial team?

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.

Where is the unit?

The Clinical Trials Unit is located in the Radiotherapy Department on the first floor of the Palmerston North Hospital.

What are its aims?

We aim to:

Provide access to new treatments.
Improve understanding of cancer and haematological conditions.
Improve standards of care by taking part in high quality clinical trials.
Help advance treatment for cancer and haematological conditions.

What types of trials are offered?

Trials we conduct are usually international studies and may include studies in:

Haematological conditions such as Deep Vein Thrombosis
Breast cancer
Lung cancer
Colo-rectal cancer
Ovarian cancer
Prostate cancer
Bladder cancer
Leukaemia
Other cancers

How can I take part in a clinical trial?

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.
Patients from the six District Health Boards covered by RCTS can be included in a clinical trial if the trial is suitable for them and they meet the study criteria.
When treatment is being planned your doctor may ask you to consider taking part in a clinical trial which is suitable for you. Alternatively, you may like to ask your doctor if there is a trial for which you would be suitable. Or, you may like to contact one of the Clinical Trials Unit staff (see How do I contact the Clinical Trials Unit?)
If you are included in a trial it may mean that you have your treatment at Palmerston North Hospital.

What is a clinical trial?

A clinical trial is a study that tests new and possibly better ways of improving people’s health.
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
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. This may involve using a new cancer drug, a new form of surgery or of radiation therapy. In some cases, clinical trials may investigate new combinations of a range of different treatments and therapies.
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.

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.

Why have clinical trials?

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.
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.

Are clinical trials safe?

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, all serious events and any changes to the trial plan. A trial plan cannot be changed without the re-approval of the ethics committee.
Clinical trials will also 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.

Why do people enter clinical trials?

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.

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

It is important to consider the risks and benefits of becoming involved in a clinical trial.
Potential benefits are discussed in the section “Why do people enter Clinical Trials?
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.

What are some features of clinical trials?

If you are thinking of taking part in a clinical trial or are already in a trial you may hear reference to words such as trial phase, protocol (trial plan), patient consent, randomization (choosing of available treatment by chance), placebo (dummy treatment) and quality of life. These features are explained below.

The three phases of clinical trials

Clinical trials are classified into three phases, each phase representing a different step in the testing of a new treatment. Each step allows researchers to ask and answer important questions about the type of treatment and its effectiveness and safety for patients. Generally our Trials Unit conducts Phase III trials, and occasionally, Phase II trials.

Phase I trials: Phase I trials determine the most appropriate way to give a new treatment. For example, should it be given by mouth, injected into the blood or injected into the muscle? These studies also evaluate what dose is safe and how often it should be used. A Phase I trial focuses on the safety of a treatment and generally involves only a small number of people.

Phase II trials: A Phase II trial determines how well a new treatment works. These trials test the safety of the treatment at a more advanced level than Phase I trials and evaluate the effect of the treatment.

Phase III trials: These studies compare a new treatment with current standard treatments. Phase III trials are conducted only if the results of Phase I and II trials show that the new treatment is safe and effective and likely to be as good as, or better than, the standard treatment. Phase III trials involve hundreds of patients, often from around the world.

Trial protocol

All clinical trials have a trial plan called a trial protocol. Everyone doing the trial must follow the guidelines contained in the protocol.
The protocol describes the reasons behind the trial, how patients will be selected, how the treatments will be given, what tests will be done, how participants will be monitored, how and at what time points the trial will be analysed and reported and so on.

Patient Consent

No patient should ever be included in a clinical trial without giving their consent in writing. It is required by law and is an essential part of being in a clinical trial.
Before giving consent and joining the trial:

The doctor should tell you all about the study.
You will be given an Information Sheet which will contain all the information you should know about the trial.
You should understand why the trial is being conducted, the potential risks and benefits and what your involvement would be.
You should be satisfied that you have enough information to make an informed decision and should feel free to ask any questions that you believe are important in helping reach a decision.
You should be given enough time to think about the trial and what it will mean to you before you decide.

If you decide not to take part in the trial your decision will be respected and you do not have to give a reason. There will be no change in the way that you are treated by the hospital staff and you will be offered the standard treatment for your illness.
If you decide to take part in the trial, you will be asked to give your consent in writing, that is, to sign the Consent Form. This form will be countersigned by the Doctor and you will be given a copy. This whole process is called informed consent. The consent process is on-going and you should receive any new relevant information about the trial when it becomes available.
Even after giving consent, you are free to withdraw from the trial at any time without giving a reason and without this affecting your future care.

Randomization

If a trial is comparing more than one treatment, the participants may be randomized. This means that, of the treatments available on the trail, the particular treatment you receive will be chosen by chance (i.e. randomly) so neither your doctor nor you choose.
If the doctor decided who should get which treatment, they might be influenced by what they know about their patient. Consciously or unconsciously they might put patients who were more or less likely to respond to a new treatment into a particular group. This would introduce bias.
Randomization ensures that all patients on a trial have an equal chance of getting one or other of the treatments. It ensures each group has a similar mix of people so the groups can be compared without bias.

Blinding and placebos

In a study of a new treatment, neither the patient nor the doctor may be told which treatment the patient is getting. This is called a “double-blind” study.
If people know they are taking the new treatment, they might expect it to work and report positive reactions because they want to believe they are getting better. This can make the trial results look better than they really are.

Blinding is done by making the medicines look the same so that they cannot be told apart. Sometimes this involves “dummy” (placebo) treatments that look the same as the new treatment but don’t contain the active ingredient (a Placebo would not be appropriate for a Phase III cancer trial).

In an emergency the doctor can always find out from the trial centre which treatment his or her patient is having.
The study Information Sheet will tell patients if the trial they are considering is blinded or if some people will receive a placebo.

Quality of life

Many studies not only measure the effect of a treatment on a disease, but also how that treatment impacts on a person’s life.
You may be asked to fill out questionnaires to measure how the treatment has affected your quality of life. The questionnaires, called Quality of Life questionnaires, ask people how they feel and how they are able to carry out everyday tasks. The effects are compared with those of other treatments.

What are my rights as a participant?

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 do decide to take part in a study your rights are discussed in the section “Patient Consent”.

Who can answer my questions or concerns about a study or about my rights?

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. His name will be on the Information Sheet.
Alternatively any queries or concerns regarding your rights as a participant in a study can be answered by the Health and Disability Services Consumer Advocate for the mid and lower North Island. Their telephone number is freephone 0800 42 36 38 (4 ADNET) or 0800 377 766.

What considerations are given to Maori participants?

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

What other questions should I ask?

Here are some other questions which you may like answered 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?

All these questions can be answered by your doctor or should be available in the Information Sheet provided to you if you are considering participating in a clinical trial.