Are ANZGOG clinical trials safe?
Clinical trials are research studies conducted on people by researchers and doctors to find better ways of treating diseases in an ongoing challenge to improve health care. Every research study or clinical trial, tries to answer a specific scientific/medical question that would advance the prevention, diagnosis or treatment of a disease or would improve the quality of life of the patients suffering from that disease. A clinical trial or research study compares the potentially new or improved method/treatment against the existing best or most effective method/treatment practiced by the medical profession to ensure its safety and effectiveness. It is through the success of a clinical trial that any new or improved treatment for a particular disease or a better means of prevention and diagnosis for that particular disease becomes available to all patients and to the public. The treatments and care that are currently considered the most safe and effective for gynaecological cancers have become available to the public as the standard treatment or care because they have been tested and proved successful on groups of gynaecological cancer patients in clinical trials over the past years.
A Clinical trial in gynaecological cancer research is explicitly designed to:
1. Identify the best possible treatment for a gynaecological cancer by comparing a new treatment to the standard of care; OR
2. Demonstrate a better/different way to use the existing treatment for a gynaecological cancer; OR
3. Measure improvements in gynaecological cancer patients quality of life after a certain treatment; OR
4. Obtain scientific information about prevention and early detection of gynaecological malignancies.
Past successful clinical trials in gynaecological cancers have been the catalyst for scientific findings such as :
· It is possible to alter or regulate the dosage of certain drug treatments to improve quality of life or to delay the re-occurrence of gynaecological cancers.
· Certain types of gynaecological cancers respond best to a combination of treatments for example surgery and radiation, or radiation and chemotherapy as opposed to just one type of treatment alone.
· The delivery of known drugs in different ways such as directly into the abdominal cavity assists in improving the quality of life or delaying the recurrence of gynaecological cancers.
Are ANZGOG clinical trials safe?
Any new or improved treatment tested in an ANZGOG clinical trial has already been established as safe and effective, first through long-term, meticulous lab-testing followed by the successful testing of the new or improved treatment on a very small group of patients in a phase 1 trial.
A phase 1 trial is conducted often on only about a dozen patients to first test how best this new or improved treatment should be given ((by mouth, injected into the blood or injected into the muscle), the safest dosage (if relevant) and how frequently it should be administered. Phase 1 trials are the most risky as there is more uncertainty and are usually undertaken by patients who have not responded to existing treatments. ANZGOG does not currently run any phase 1 clinical trials.
ANZGOG only runs phase 2 and phase 3 trials.
A phase 2 trial continues to test and monitor the safety of the treatment and begins to evaluate how well it works on more people, usually on about 20 to 50 patients suffering from the same type of cancer. These patients are closely monitored for side effects and undergo numerous scans and blood tests to measure the effects of the treatment.
A phase 3 trial has successfully progressed through phase 1 and 2, and is designed to test a new or improved treatment in comparison to the existing best standard treatment. It is conducted on hundreds of participants with the same type of cancer. A participant will usually be assigned to either the group receiving the current standard treatment or to the group receiving the new or improved treatment at random, this process of random assignment is called randomisation and is done thru a computer to minimize any bias in the selection process thus ensuring the validity of the results of the research study. Phase 3 trials are conducted at doctors' offices, clinics, and cancer centers nationwide and worldwide. Participants in phase 3 trials are also very closely monitored for side effects and to measure the effects on their cancer as well as their length and quality of life. This is the only way to determine whether the new or improved treatment is more effective than the existing standard treatment.
ANZGOG phase 2 or phase 3 clinical trials ensure high levels of safety because there is recorded experience with the treatment being tested and so the clinical trial physicians are aware of most of the benefits and risks of the new or improved treatment being offered through the particular clinical trial. Furthermore, the close monitoring of the patients on these studies ensures that any unexpected side effects will be noted and treated promptly.
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Will I get better care being on an ANZGOG gynaecological clinical trial?
Yes. As an ANZGOG gynaecological clinical trial participant you will be receiving at least the existing best standard treatment for your diagnosis or potentially a better treatment or combination of treatments for your diagnosis. You will also have a clinical trial team consisting of leading gynaecological oncologists very closely monitoring any side effects and your disease progression. Any side effects will be treated immediately. Being on an ANZGOG gynaecological clinical trial will likely entail more visits with your treating physician, more scans and more blood tests giving you a clearer picture of the status of your health. You will also have access to a medical research team to answer all your questions regarding your diagnosis and access to more medical documentation/information. You will also have follow-up treatment by these leading gynaecological oncologists during the follow-up period of the clinical trial. You will have a more active role in your health care.
You can withdraw from an ANZGOG gynaecological clinical trial at any time, before the study starts, during your trial treatments or during the follow-up period.
What is Informed Consent when considering participating in a gynaecological clinical trial?
Informed consent is the process of learning all the key facts about the particular clinical trial you are considering before deciding whether to participate. Your research team of gynaecological oncology physicians and nurses will give you all the necessary information for your to be fully informed before participating in a clinical trial. This information is documented in the Informed Consent Form that you will be required to sign before participating in the trial. You will be able to take this form home to read and discuss before signing. The Informed Consent Form will detail the question to be answered through the clinical trial, the intervention given in the trial, any possible risks and benefits, the tests you may have to undertake and the expected length of the trial. Informed consent continues as long as you are on the study, thus giving you full disclosure of the study status and results at all times.
The Informed Consent Form is a legal document; therefore, it is very wordy and at times very detailed and hard to understand. You should feel free to ask the clinical trial team any questions you have regarding the form or the trial, even before agreeing to join the trial, they are there to ensure you understand all that the trial entails, side effects, benefits, any costs to you, risks and all. It is a legal requirement for you to have full disclosure on the gynaecological cancer clinical trial you are considering.
The Placebo misconception
There is a common misconception in the community that all clinical trials involve half the participants being given a placebo or no treatment while the other half of participants receive treatment for their diagnosis. This is not true. Ethically, clinical trial participants have to be given at least the existing best standard of care for their diagnosis. In a clinical trial testing whether a new or improved treatment is better than the current best standard treatment, half the trial participants would receive the current best standard treatment while the other half would receive the already lab-tested, safe and effective, new treatment that is considered potentially superior, but cannot be made available until clinically tested first. This selection process is randomly carried out using a computer and is known as Randomisation. This allows for the unbiased scientific measurement and comparison of a new treatment against the current best available standard treatment.
Blinded randomization is when the patient in unaware of which treatment they are receiving - the standard of care or the new treatment.
It is only when a gynaecological cancer diagnosis has no current standard treatment available, a placebo (a tablet containing no active ingredients, but looks like the trial medication) is used. In this case, half the trial participants are given the already lab-tested, safe and effective new treatment and the other half are given the placebo. This selection is done thru double-blinded randomisation, with neither the patient nor the doctor knowing which arm of the clinical trial the participant is in. It is only the study coordinating centre that has this information. Thus, an unbiased evaluation of the effects of the new treatment can be recorded.
How is an ANZGOG gynaecological cancer clinical trial created?
An ANZGOG gynaecological clinical trial undergoes a very rigorous scientific process before becoming an active trial. First, the scientific medical research question to be answered is determined. Then the research study plan outlining the procedures/interventions required to answer the question is compiled. The blue print for the proposed clinical trial is thus created, identifying all procedures, trial participants, test schedules, medications and dosages, length of the study, follow-up processes, data collection and analysis processes is called the clinical trial Protocol. The protocol is carefully designed to safeguard the health of the participants as well as justify and answer the specific research question. Every site participating in the clinical trial uses the same protocol to ensure the medical treatment is the same for all participants across all sites.
The clinical trial protocol undergoes rigorous scrutiny and is review by the Research Advisory Committee of ANZGOG consisting of leading gynaecological oncology researchers and physicians, statisticians, psychologists, a consumer and a research nurse. Following this the protocol is sent to the Ethics Committee of the University of Sydney and Ethics Committees at each of the sites that will participate in the trial. A protocol could be amended numerous times before all relevant ethics approvals are received. It is only once the protocol passes all ethics approvals that the gynaecological cancer clinical trial becomes activated and open for recruitment.
Who funds ANZGOG gynaecological cancer clinical trials?
ANZGOG clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, pharmaceutical companies, in addition to state and federal bodies such as the National Health and Medical Research Council, Cancer Australia and the Cancer Institute.
Why do women participate in ANZGOG gynaecological clinical trials?
The ANZGOG Consumer/Community Committee, through their own individual experiences and/or thru their discussions with other trial participants have outlined the following as some of the major reasons women participate in gynaecological cancer clinical trials.
· Patients on clinical trials will always receive at least the best existing standard treatment or a new treatment that could potentially be relatively better if not the same.
· Patients on clinical trials are better informed of their diagnosis and treatment as they have access to extensive documentation.
· Patients on clinical trials receive an extra level of care and supervision from their medical team who will closely monitor their progress throughout their clinical trial treatment and through the follow-up phase of the trial.
· Patients on clinical trials could have access to a new treatment before it is made available as the standard of care to all gynaecological cancer patients.
· Some patients participate in clinical trials because they want to be involved in advancing science and ensuring a better future for all women. They want to be a part of assisting scientists and medical practitioners discover new and better ways to treat the disease that they suffer from.
· There is medical research that scientifically proves that women on clinical trials are more likely to have a better outcome.
· Patients on clinical trials more often feel empowered from their participation, they feel they are more actively involved in their own health care.
How can I find out about ANZGOG gynaecological clinical trials and other clinical trials?
If you would like to consider a taking part in an ANZGOG gynaecological clinical trial or another clinical trial and one has not been suggested to you by your doctor, you may ask your doctor to suggest a suitable trial you would be eligible to participate in. However, if your clinician is not involved in any clinical trial or your hospital is not registered to run an ANZGOG clinical trial or other clinical trials, you can go to the clinical trial registry at www.anzctr.org.au where all clinical trials conducted in Australia and New Zealand are listed or you can click on ANZGOG trials open to recruitment if you would like information on ANZGOG clinical trials.
Once you find out about a particular clinical trial that relates to your diagnosis you can ask your doctor about it, or you could contact the principal investigator listed on the trial to obtain further details including a participating site near you.
The trial will be explained to you in great detail by your physician to enable you to make an informed decision whether you want to partcipate. You will not be disadvantaged if you chose not to participate in a trial.
Please note that enrolment in a clinical trial can only be done through a medical practitioner. Neither ANZGOG nor the Clinical Trials Centre staff can enroll you in a clinical trial.