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  1. Clinical Trials

Access to state-of-the-art clinical trial

Over the last few years, clinical trials have become the method of choice for evaluating new therapies, and patient randomisation is now considered almost indispensable to establishing the superiority of new therapeutic approaches over standard ones. The vast majority of oncologists basically agree that properly-conducted clinical trials are the surest way of testing new therapeutic regimens and identifying small, but worthwhile, treatment benefits.

New cancer treatments are usually studied in a sequence of clinical trials. There are basically three phases in this sequence. Phase 1 clinical trials purport to determine the dose at which the treatment is to be effectively administered. Phase 2 clinical trials are used as a screen to reject inactive treatments from further study. Finally, phase 3 clinical trials compare the new treatment to a standard, established treatment. Clinical members of the Prostate Cancer Institute are actively involved in both phase 1, 2 and 3 clinical trials. For example, Dr Paul de Souza has a heavy commitment to phase 1 clinical trials, which examine new chemical compounds, shown to be active in the test tube and in all screening systems. Phase 1 trials are essentially a dose-finding experiment in patients who are no longer expected to benefit from any known therapy. The purpose of the phase 1 trial is to determine the maximum tolerated dose, which is the maximum dose of the compound that can be administered according to a specific route and schedule with an acceptable toxicity.

PCI members are also heavily involved in phase 3 clinical trials, which involve two or more treatments with the primary purpose of determining the relative merits of each. Some phase 3 trials attempt to show that a new treatment is more effective than a standard treatment; others attempt to show that a new treatment is as effective as a standard therapy but with less morbidity.

A clinical trial is typically a major undertaking, which must satisfy a number of scientific and ethical requirements, and which is only feasible if appropriate logistic and financial support is available.

The most important document in a clinical trial is the protocol, which is a self-contained written prescription of the rationale, objectives and logistics of the study. Particular care must be taken to define the objectives of the trial and the hypothesis to be tested as clearly as possible. Response to treatment is a relevant end point in assessing treatment effectiveness against measurable advanced disease. The achievement of a response is an important marker of biological therapeutic effect and is often associated with both objective and subjective improvements in a patient’s condition. However, the achievement of a higher response rate is not sufficient on its own to establish treatment superiority. The nett therapeutic benefit to the patient must also take into account treatment toxicities and the duration of survival or other time-related end points.

Patient follow-up is usually a major difficulty in trials extending over long periods of time. It is essential to minimise the number of patients who are lost to follow-up during the course of a clinical trial as such losses to follow-up may bias the trial results if they are related to the treatment itself. The success or failure of a clinical trial depends critically on the study co-ordinator who must first “sell” the trial concept to potentially interested colleagues, then monitor the ongoing trial and check all incoming data and finally report the trial results. This is a heavy responsibility for single individual, particularly when he or she is a busy clinician with competing demands and priorities. As well as a dedicated co-ordinator, the successful conduct of a clinical trial typically requires substantial logistic support from a team specialising in data management, computer science and biostatistics.

At any one time within the Division of Cancer Services and the Prostate Cancer Institute, there are a large number (more than 30) clinical trials being conducted. It is our hope that as many patients as possible will be able to enter a clinical trial in order to assess the effectiveness of new therapies over older conventional ones. For further information, please contact our Clinical Trials Unit on 02 9113 1935. The Clinical Trials Unit regularly publishes a Newsletter in order to keep clinicians within the Division of Cancer Services informed of the progress of each trial.

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