Clinical trials

Clinical trials play an important role in a research process that can take years before new treatment options become part of standard breast cancer care. Most of the major advances in breast cancer treatment have occurred because the value of new treatments was first demonstrated in clinical trials. Two major advancements include breast conservation as a safe alternative to mastectomy, and the addition of chemotherapy and hormone therapy to surgery to improve survival outcomes. More recent advances due to clinical trials are the use of sentinel node biopsy as an alternative to removing all the underarm nodes and the introduction of Herceptin.

• Trained and supported consumers who represent the constituency of breast cancer consumers (rather than just themselves as individuals) should be engaged at every step of the research process, including:

  - design of trials

  - development of protocols

  - preparation of informed consent material

  - monitoring and reporting of trials.

• All women should have the option of participating in clinical trials that are suitable to the treatment of their breast cancer and their care needs.
• The choice of whether or not to participate in a clinical trial is intensely personal. A woman's treatment should not be neglected by her doctors no matter what she decides.
• All women should be able to opt out of clinical trials at any time for whatever reason without their future treatment options being affected by their decision.
• Those establishing clinical trials should consider access issues for women living in rural and remote areas so they are not disadvantaged in participating.
• The language of informed consent material should be as clear as possible for the lay person and not cluttered with complex concepts and jargon. It is essential that women feel truly informed and comfortable with their participation in clinical trials if this is their decision.
• Women involved in clinical trials should be kept informed about the progress of their trials and any results that may influence their ongoing participation.
• Trial results should be published whether they are favourable or unfavourable.
• The National Health and Medical Research Council should continue to fund the Australian Clinical Trials Registry and ensure its development as an accessible database for potential clinical trial participants.

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