“I wanted my cancer to mean something. When I heard about a clinical trial testing a new treatment for breast cancer that offered better chances of survival with less of the debilitating side effects of surgery, I knew I had to take part.” Loretta Marron, breast cancer survivor
Definition of clinical trials
Clinical trials are the formal, scientific testing of new medical procedures, drugs and devices.
They are critical to ensure the latest treatments are safe and effective before they are made available to the community.
New treatments must go through various phases of testing or trials before they are made available to the market.
Types of clinical trials
There are five main categories of clinical trials which are outlined below. The Wesley Research Institute specialises in trials in phases I – IV.
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Pre-clinical trials
These are trials that occur prior to human testing and may involve lab and / or animal testing. The clinical trials team at The Wesley Research Institute does not conduct pre-clinical trials, although such studies may be carried out within university laboratories in collaboration with Wesley clinicans.
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Phase I clinical trials
These trials are the first time new treatments are tested in humans to confirm safety. Phase I trials involve a small group of healthy volunteers taking the study drug (usually a single dose) and their responses and reactions are closely observed and recorded to confirm the treatment is not harmful.
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Phase II clinical trials
The effectiveness of a new treatment is measured with a moderate number of
patients (a greater number than those in Phase I) who have the disease or
condition in question. Information is collected about how effective the treatment
is at different doses and what side effects, if any, are observed.
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Phase III clinical trials
In this phase, the treatment’s efficacy (or effectiveness) is compared to current treatments.
Phase III trials involve large numbers of participants (usually thousands); usually take several years to complete; and are carried out internationally at different hospitals and centres.
Large amounts of data are collected and provided to the sponsor company, relevant research bodies or other authorities for analysis to decide whether or not to make the treatment available to the general public.
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Phase IV clinical trials
Phase IV trials allow for the gathering of even more detailed information about the treatment after it has become available to the public, such as economic and long-term safety information.
Categories of clinical trials
There are several categories of trials to measure different types of treatments.
The six main categories are:
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Bioequivalence
In these trials, two drugs with the same active ingredients are compared for safety and efficacy. The aim of these trials is to introduce generic brand (cheaper) medications to the market after the initial patent has expired. These trials compare the generic medications to the more expensive brands to ensure they are as safe and effective as the patent drug.
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Device
In these trials, new medical devices (anything from colostomy bags to pacemakers) are tested for their safety and efficacy. The aim of these trials is to introduce new devices to the market to be used in the treatment of illness or disease.
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Nutrition, neutraceuticals, and complementary medicines
There is a growing need to conduct trials in the areas of nutrition or vitamin supplements, neutraceuticals, and complementary and alternative medicines (such as fish oil and St John’s Wort). The aim of these trials is to provide scientific evidence for claims that these therapies are effective in managing symptoms of illness or disease.
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Pharmaceutical and biotechnology
In these trials, new medications and treatments are tested for their safety and efficacy. The aim is to introduce new medications and treatments to the market to treat illness or disease more effectively or with fewer side effects.
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Surgical
These are trials that compare the safety and effectiveness of new surgical procedures.
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Vaccination
These trials test new vaccines (from flu vaccines to cancer vaccines) for their safety and efficacy. The aim is to introduce new vaccines to the market that are both safe and effective in preventing illness and disease.
General information
For further information on clinical trials visit:
Therapeutic Goods Administration
www.tga.gov.au
National Health and Medical Research Council (NHMRC)
www.nhmrc.gov.au
Queensland Clinical Trials Network
www.qctn.com.au
Australian Clinical Trials Registry
www.actr.org.au/
For more information about clinical trials at The Wesley Research Institute, please contact the Clinical Trials Centre on 07 3232 7920 or send an email to clinicaltrials@wesley.com.au.
