What are clinical trials?

Clinical trials are scientific research studies involving patients. They are specifically designed to answer a particular question, which usually has to do with identifying new and/or better ways to detect, treat or prevent cancer.

What are the different types of clinical trials?

Clinical trials can fall into several different categories, such as:

  • Prevention studies, which test how types of cancers can be prevented in people;
  • Detection studies, which test ways in which types of cancer are diagnosed, with the aim of increasing the chance of early diagnosis;
  • Treatment studies, which are conducted to find out which treatments are the most effective, and to test new treatments to see if they are more effective than existing standard treatments. Treatments tested can include drugs (chemotherapy) as well as radiotherapy, surgery, and complementary therapies;
  • Quality-of-life studies, which look for ways of improving the overall comfort of patients with cancer, and;
  • Cost-effectiveness studies, which compare new treatments with existing treatments in terms of costs, efficiency, and benefits.

Who runs clinical trials?

Clinical trials are run by teams of researchers at universities, hospitals and private institutions. The Australasian Gastro-Intestinal Trials Group (AGITG) coordinates most GI cancer trials in Australia and New Zealand. The AGITG has been conducting clinical trials for the last 23 years and there are many doctors and research professionals who volunteer their time to conduct these trials. Each clinical trial has a Study Chairman who is in charge of running the trial and a Principal Investigator (PI) from each institution taking part.

Why are clinical trials important?

Clinical trials are necessary to find out if new treatments are more effective than those currently accepted as the best available standard therapy. Trials are also essential for new, improved treatments to be adopted, as all treatments and procedures must be scientifically proven before they can be made widely accessible. Furthermore, because not all people or cancer tumours are the same, clinical trials are needed in order to test how effective different types and/or combinations of treatments are for different people and tumours.

Additionally, conducting clinical trials in Australia means patients are able to access new treatments three to five years earlier than if they were conducted overseas.

What are the benefits of clinical trials to participants?

Clinical trials provide many benefits to participants. For example:

  • Patients who participate in clinical trials often receive immediate access to the latest treatments before they are made widely available to cancer patients.
  • The treatments offered on a clinical trial are either the best current standard therapy or therapy that is thought to be as good, or better, than the current standard therapy.
  • Some patients worry that they will receive no treatment if they are allocated to a control group, however all clinical trials are required to ensure that all patients receive at least the same level of treatment that would have been prescribed for them if they did not participate in the trial.
  • Patients involved in clinical trials receive an excellent standard of care, and are closely and regularly monitored by leading doctors, research nurses, and other medical experts.
  • Research shows that patients treated in clinical trials usually have greater cure rates and a better quality of life than those who are not involved.
  • Patients who take part in clinical trials play an active role in ensuring future cancer sufferers have access to the best medication.

Are clinical trials safe?

No cancer treatment is guaranteed to be successful and most treatments have a number of side effects, and the treatments given in clinical trials are no exception. However, clinical trials must conform to a number of safety rules before they are approved by an independent ethics committee. Researchers must ensure that clinical trials are scientifically sound, that they do not produce more harm than good, that they keep patients informed of developments and results, and that they meet internationally agreed standards about the right way to carry out research involving people.

Before joining a trial, participants must be given accurate information about the study that outlines the purpose, all foreseeable benefits and risks (including side effects), full details of what is required of patients, and patients’ rights. Once all information about the trial is understood, the patient will sign a patient information and consent form. Most importantly, participants are free to opt out of the trial at any time for whatever reason, without any compromise to their future medical care.

What is randomisation?

If a trial involves more than one type of treatment, then a participant’s particular treatment is chosen for them randomly from the available trial treatments. This means that all patients on a trial are equally likely to receive the standard or the new treatment. If patients do not receive the new treatment they will receive the best standard available treatment; there will not be any control group that receives no treatment. Sometimes the participant will not know what particular treatment plan they are on and neither will their doctor. This is known as a double blind approach, in which any potential bias is minimised.

What are the different phases in clinical trials?

Early initial trials are known as Phase I and Phase II trials. Many patients involved in these trials are people for whom current treatments are no longer effective. These trials involve small numbers of patients, and are used to determine whether new treatments are effective and safe enough to progress to Phase III trials.

Most clinical trials for cancer are Phase III trials, which compare new treatment options with current treatments. In Phase III trials, much information about the benefits, risks and side effects of the treatments under study have already been discovered through smaller trials. New treatments are not considered for Phase III trials unless they are shown to be an improvement on current standard treatments, and are at least as safe as current treatments.

How can I take part in a clinical trial?

When you are discussing treatment with your doctor, they may suggest that you participate in a clinical trial or tell you about a trial for which you would be eligible. If they do not, you can ask your doctor if there is a trial for which you would be eligible. Alternatively, you can find trials on the Australian Cancer Trials website and discuss their suitability with your doctor.

However, in some cases there will not be a trial available that you and your type of cancer would be eligible for, as trials are usually very specific. In addition, if you have certain health conditions such as a susceptibility to particular side effects, or if you are taking other medications, you may be ineligible for some clinical trials.

If you are eligible for a suitable trial, take time to reflect on the information, discuss things with family and friends, weigh up the pros and cons, and have further discussions with your doctor before you come to a decision.

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