What happens in a clinical trial

By Jenni Scarlet, Research Nurse, Breast Care Centre, Waikato Hospital, Hamilton

What is a clinical trial?

Clinical trials are research studies where a new treatment is tested against a best available or standard treatment. Clinical trials involve people working with research staff (including doctors and nurses) to help find ways to improve health and care of people with diseases such as breast or other cancer.

In cancer care, a clinical trial is one of the last stages of a lengthy and careful process that often starts many years earlier in a laboratory.  Trials are a link between discoveries made in the cancer research laboratory and making new treatments available for people diagnosed with cancer.

New cancer drugs are required to go through a number of safety checks before being used in humans. New cancer treatments go through a careful process of testing to ensure safety first.  The testing of a new drug progresses in an orderly series of steps called phases. New drugs are first tested in people with terminal illness. If effective in terminal or advanced cancer they can then be tested in people with early cancer.

What types of clinical trials are there?

Trials are carried out to find out whether new and potentially promising ways of detecting, preventing or treating cancer are possible and if they are safe and effective.  Some studies also look at ways of improving quality of life or evaluate the cost effectiveness of a new approach.

  • Detection or screening trials evaluate the best approach to find a cancer in its early stages; for example, mammograms (breast xrays) or cervical smears.
  • Prevention trials test new approaches; for example, use of medicines or healthy lifestyle changes; that may lower the risk of getting a certain cancer.
  • Treatment trials test new treatments, for example, drugs such as chemotherapy or hormonal treatments.  New radiotherapy or surgical techniques are also tested. 

Counselling and psychological support or ways of providing better communication are also part of treatment trials.

Why participate in a clinical trial?

The most common spontaneous feedback regarding why women take part in breast cancer trials is that their participation may help future generations. Participation in a clinical trial does assist with the advancement of medical knowledge.

People take part in trials for a number of different reasons.  They may receive a new treatment before it is widely available to other cancer patients. Evidence shows people can also have a better outcome because they have been involved in a trial, even if they have received a standard treatment.  This may be because most participants on a clinical trial receive carefully and often more rigorously monitored treatment and follow-up.

What is a trial protocol?

Researchers testing new cancer therapies follow strict guidelines.  Prior to starting up a trial a detailed action plan of how the research will be carried out is written.  This is called a protocol.  Before a clinical trial can commence the protocol must be reviewed and approved by an ethics committee at each centre or hospital where the research will take place.  An ethics committee is an independent panel of scientists, health professionals and laypeople. The ethics committee will particularly want to check that potential participants are given very detailed information and prior to approving a trial, what risk of adverse events are present, if any.

The research team carrying out the trial must follow the protocol which gives instructions on such things as:

  •     reasons behind doing the trial,
  •     what patients are suitable for participation in the study,
  •     how many people will be in the study,
  •     how treatments will be given (e.g. by mouth, injected into the blood or muscle),
  •     what trial tests will be done and how often,
  •     how patients will be monitored,
  •     what information will be gathered,
  •     how trial results will be analysed and reported.

Is a trial suitable for you?

Your Oncologist (Cancer Doctor or Specialist) may suggest that you consider taking part in a clinical trial. Or if you are interested in taking part in a study but have not had this suggested, ask your Oncologist.  They may be contributing to a suitable trial or know of one being done at another centre.

If you are interested in taking part in cancer research, your Oncology Doctor will explain a trial to you including the known benefits and risks of a new treatment or procedure. A patient information sheet giving the detail of the research will also be given to you before you agree (consent) to take part in a trial.

Why are clinical trials important in breast cancer care?

All the major advances in controlling breast cancer have been the result of clinical trial research.  This includes:

  •     Our ability to use breast conserving surgery instead of mastectomy (removal of the whole breast) for many women,
  •     Saving lives with regular mammography screening,
  •     Saving lives with better drug treatments, both chemotherapy and hormonal therapies,
  •     The entry into the era of highly targeted therapies aimed at breast cancers which have specific features present e.g. Herceptin for HER 2 positive breast cancer,
  •     Improvements in radiotherapy and surgical techniques,
  •     Breast cancer prevention.

It is extremely important that all new therapies and procedures be scientifically proven and long term safety determined before they can be recommended for general or standard use.

Additional tests or questionnaires to fill in regarding a patient's feelings or side effects to treatment are required to evaluate safety and impact on quality of life. This all helps with the collection of detailed and accurate information and thus the overall accuracy of trial results.

Where are the participating centres for breast cancer clinical trials in New Zealand?
In New Zealand, breast cancer clinical trials are available at Cancer Centres or Breast Clinics at North Shore, Auckland, Waikato, Palmerston North, Wellington, Christchurch and Dunedin Public Hospitals.  Some cancer specialists in private clinics participate in breast cancer clinical trials.  Do ask your treating Oncologist if there is a clinical trial available for your situation!

Some relevant web sites for information on cancer clinical trials