What is a clinical trial?

20 May 2021

WomenCan raises funds to support gynaecological cancer clinical trials conducted by ANZGOG.

ANZGOG is a world leader in gynaecological cancer research. Over the last 20 years, ANZGOG have conducted close to 40 trials, treating 3,000+ patients.

What is a clinical trial?

All new treatments have to be scientifically proven before becoming available to the general public. This includes treatments and early detection tests for gynaecological cancers.

Trials are designed to:

  • Identify the best possible treatment for a gynaecological cancer; or
  • Investigate whether a new treatment improves outcomes compared to an existing treatment; or
  • Determine the impact of a treatment on the patient’s quality of life; or
  • Make new discoveries in prevention and early detection of gynaecological malignancies.

Clinical trials have been the catalyst for new treatments for gynaecological cancer patients.

"Virtually every advance in cancer survival has been made on the back of a clinical trial." Assoc Prof Alison Brand, Gynaecological Oncologist.

What does a trial Phase mean?

Clinical trials are conducted in phases. Trials consist of four phases, with each phase having a specific purpose to help scientists answer various questions.

Phase I

Phase I clinical trials involve administration of the research treatment into healthy human participants for the first time. These trials are conducted in a small number of healthy participants to gather information about the safety and potential side-effects the research treatment may cause in the human body. The participants are carefully monitored for the duration of the entire trial.

Phase II

Phase II clinical trials are conducted with a group of participants who have been diagnosed with the disease the treatment was intended for. During a Phase II trial, information is gathered about the safety and effectiveness of the research treatment in these patients.

Phase III

Phase III clinical trials are conducted in a larger group of patients to compare the research treatment with the current standard of care treatment. These trials are used to gather large amounts of information about how the research treatment treats the disease compared to the standard treatment. Governments and other authorities will use this information to decide whether the risks and benefits of the new treatment justify it becoming available to the public.

Treatment Registration – Once a treatment has successfully completed a Phase III clinical trial, the sponsor is able to register the treatment with the appropriate government agencies. After the treatment is registered, it may become available for use in a clinical setting (at full cost depending on the PBS).

Phase IV

Phase IV trials are conducted after the treatment has become available to the public. These trials are conducted to gather information about the safety and effectiveness of the treatment over a long period of time. Information is also gathered to investigate if the treatment can be used in other circumstances. All clinical trials are conducted by an Investigator (doctor) and their research team, consisting of Research Nurses, Study Coordinators, Pharmacists and other health care professionals.

"Clinical trials are about making available a drug for illness to make it better, stable or go away all together." Assoc Prof Yoland Antill, Medical Oncologist.

Are clinical trials safe?

WomenCan understands that a cancer diagnosis creates a great deal of uncertainty for patients, particularly when deciding on treatment options. When considering these options, participating in a clinical trial may seem daunting and safety may be of concern. Which is why WomenCan believes that safety is of the upmost importance in relation to clinical trials, and why we support ANZGOG's research.

ANZGOG's gynaecological clinical trials undergo a rigorous review process before becoming active. This ensures the reliability of the research and the safety of the patient.

No gynaecological 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.

The key points to understand are;

  • Clinical trials must adhere 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
  • Researchers keep patients informed of developments and results at the end of the trial
  • Clinical trials must meet internationally agreed standards about the right way to carry out research involving women. 

"Without research, it is likely I wouldn't be alive today."  Wanda Lawson, ovarian cancer survivor.

How to participate in a clinical trial

WomenCan always recommends speaking to your treatment team, including your Medical Oncologist about your eligibility for clinical trials.

Are you interested in participating in a clinical trial?

Join the WomenCan community

There is a critical need for funding of gynaecological cancer research. WomenCan engages the community to fund pioneering discoveries that will enable women with gynaecological cancer to live better and live longer.  We have seen first-hand how strong, determined and courageous women are in the face of a life-threatening disease.  We believe that WomenCan be even stronger with you, the community, by our side. All donations to WomenCan are tax-deductible. 

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