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1 Clinical Trials An information sheet for women with ovarian cancer, their families and friends Treatment for ovarian cancer usually involves a combination of surgery and chemotherapy and sometimes radiotherapy. The type of treatment women receive is dependent on the type and stage of their ovarian cancer and their general health. Sometimes women are interested in finding out what treatments are currently being developed or their doctor might ask if they would like to participate in a clinical trial. The following information will tell you more about clinical trials; what they are, what s involved, how to find out about current clinical trials and some questions you might like to ask your medical or research team when considering a clinical trial. What is a clinical trial? A clinical trial is a study conducted to test the safety and effectiveness of a newly developed approach to prevention, diagnosis, treatment and quality of life for a specific disease or condition. Such studies are conducted by researchers and medical professionals on people who fit specific clinical trial criteria and who voluntarily choose to participate. Why do clinical trials exist? Clinical trials are vital for the development and progression of treatment for ovarian cancer and many other diseases. Prior to clinical trials, treatments are extensively tested in laboratories. This enables researchers and doctors to predict the effect of a new treatment on women with ovarian cancer. But, doctors and researchers can t be sure of the actual potential beneficial effect a new treatment might have until they have collected data from a clinical trial. It is not until this data is collected and assessed that a new treatment can become available as a standard treatment for women with ovarian cancer. Who runs clinical trials and how? Clinical trials are run by a research team and usually conducted in teaching hospitals. Research team members may include doctors, nurses, social workers, dieticians, and other health care professionals. These people provide care, monitor participants health carefully, and give participants specific instructions to follow for the study. What are clinical trial phases? Clinical trials go through a number of phases to answer specific questions. Each of these phases test the effectiveness and safety of the new treatment in the hope that the new treatment will be better than the current standard treatment. As a new treatment progresses through each phase of the See over... Clinical Trials Page 1

2 clinical trial, greater knowledge is obtained about its safety and effectiveness. Phase 1 In this phase researchers and doctors want to find out how the new treatment should be given to women (e.g. mouth, injected in to blood or muscle), what dose and how often. This phase usually involves a few participants, sometimes as few as six. Phase 2 In this phase doctors and researchers want to find out how well the new treatment works for participants (response rate). This phase usually involves approximately 20 to 50 participants. Phase 3 In this phase doctors and researchers want to find out how effective the new treatment is in comparison with standard treatment. In these trials half of the participants are randomly given the new treatment and half of the participants are given the standard treatment. For the purpose of the study, participants may not know which treatment they are given. This phase usually involves a large number of people, and may be conducted at many different hospitals, clinics, and cancer centres. It may involve many hundreds or thousands of participants. Phase 4 After the new treatment has been approved and is being used as a standard treatment, researchers and doctors may want to monitor the new treatment over a longer period of time to evaluate the side effects, risks, and benefits of a drug. This phase usually involves thousands of participants. Who is eligible to participate in a clinical trial? Often clinical trials for ovarian cancer are only eligible to some women with a specific ovarian cancer experience. Like all studies the results will be more accurate if there are fewer variables. Some variables that may determine if a woman is eligible for a specific clinical trial include stage of cancer, age and previous treatments. The eligibility criteria for every clinical trial will be clearly stated in the protocol (plan which outlines the clinical trial), and you can discuss the eligibility criteria with your doctor or the principal investigator of the study. What are the potential benefits of participating in a clinical trial? Participants receive treatment from leading physicians in cancer research Participants get access to the best standard care or a new treatment which is better than standard treatment Participants are closely monitored and regularly checked for any side effects Participants have a more active role in their treatment Participants have an opportunity to make a valuable contribution to cancer research See over... Clinical Trials Page 2

3 Participants gain knowledge about latest treatments and progress with new treatment Research shows that regardless of the treatment received women on clinical trials tend to do better than women who are not involved in a clinical trial What are the potential risks for participating in a clinical trial? Participants may experience side effects or risks as a result of the new treatment Even if a new approach has benefits, it may not work for all participants During phase 3 clinical trials it is not possible to choose which treatment you have Participants may need more tests during and after treatment than with standard treatment It may be necessary to fill in more forms and surveys than with standard treatments What measures are taken to protect patients? After rigorous testing in a laboratory researchers and doctors develop a clinical trial protocol (plan which strictly outlines a clinical trial). This protocol is developed in line with the ethical principles of the Declaration of Helsinki and International Good Clinical Practice guidelines. The protocol must also be approved by independent ethics committees which adhere to the guidelines issued by the National Health and Medical Research Council (NHMRC). Additionally clinical trials are managed by a Trial Management Committee which closely monitors the trial and patients are carefully monitored by their research team. Patients are able to leave clinical trials at any time. All of these requirements exist to protect patients. Please see links to information about patient protection below. What is informed consent? Informed consent implies participants are aware of all aspects of a clinical trial including treatments, tests, possible benefits and risks and participant requirements before they make a decision to or not to participate. Participants should feel free to ask their healthcare team questions at any time. Informed consent continues as long as participants are in the study. What is required from participants? Participants are often required to have more tests and doctor visits than if they weren't participating in a clinical trial. Participants are required to go to all doctor visits, See over... Clinical Trials Page 3

4 have all tests, take medicines on time, and complete logs or answer questionnaires as instructed by their research team. Research team members may continue to stay in contact with participants after the trial ends to ensure results from the trial are as reliable as possible. Participants can change their mind and leave the study at any time. Who pays for the costs of clinical trial? Usually clinical trials are funded, including the cost of the new treatment and any additional tests, medications or procedures that are part of the clinical trial. Clinical trials are funded by a variety of people and organisations including physicians, medical institutions and pharmaceutical companies, in addition to state and federal bodies such as the National Health and Medical Research Council, Cancer Australia and the Cancer Institute. There is generally no extra cost for participants other than the cost for standard care or treatment. Sometimes money is provided to cover travel expenses, so it s a good idea to check the protocol and speak to the research team about the costs involved. How do I find out what trials are currently being offered? Doctors may tell women about a clinical trial that is appropriate for them or women can ask their doctor about specific trials for them. For information and to find out what clinical trials exist visit: Cancer Australia website. This site has an online registry of clinical trials being undertaken in Australia including the latest in cancer care and trials open for recruitment. You can search for clinical trials specific to your cancer type at The Australian New Zealand Clinical Trials Registry also has an online registry for clinical trials being undertaken in Australia, New Zealand and other countries The ANZCTR includes a range of different trials including therapeutic areas of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies and complementary therapies. Australian New Zealand Gynaecological Oncology Group (ANZGOG) clinical trials website also has a list of clinical trials currently open to recruitment. For more information about a particular clinical trial, women can ask their doctor or contact the principal investigator listed on the trial. Questions for your doctor or research team When looking exploring a clinical trial it s good to ask your doctor or research team some questions. It can also be good to take a family member or friend with you to help ask and record the questions. Listed below are some questions you may wish to ask. Clinical Trials Page 4

5 Questions continued... Why does the trial exist? What is the treatment being studied? What effect do the researchers think this treatment will have? What is known about the possible benefits of the new treatment? What is known about the possible risks and side effects of the treatment? Who is responsible for the trial? Who is involved in running the trial? Who is paying for the trial? How will I find out the results of the trial? Whom do I contact if I have concerns or questions during the trial? How will this trial fit with me? Where will I receive my treatment? What is required of me to receive treatment e.g. frequency of attendances at treatment sites? Will I be able to take my regular medications while in the clinical trial? What kinds of therapies, procedures and /or tests will I have during the trial? How do the tests in the study compare with those I would have outside of the trial? What will it cost? Are there any costs not covered by the trial which I will need to pay for? What is my health insurance likely to cover? Who can help answer any questions from my insurance company or health plan? Will there be any travel or accommodation costs that I need to consider while I am in the trial? Information on the fact sheet was compiled from the following sites: National Cancer Institute U.S. Australian New Zealand Gynaecological Oncology Group (ANZGOG) Medicines Australia (representing pharmaceutical industry) Cancer council Vic BCNA Clinical Trials Page 5

6 Links for more information about patient protection in clinical trials National Health and Medical World Medical Association developed the Declaration of Helsinki Research Council Guidelines for good clinical practice Links to on clinical trials that are currently being offered Cancer Australia Australian New Zealand Clinical Trials Registry Australian New Zealand Gynaecological Oncology Group (ANZGOG) VIC Cancer Council Victoria NSW Cancer Council NSW NSW Cancer Trials Network Additional Information about clinical trials The Australian Clinical Trial Handbook - the practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context World Health Organisation Clinical Trials Page 6