Sponsors
Human Research Ethics Committee Review
Monitoring
Randomisation
Placebos
A new medical treatment must be tested in clinical trials and found to make a beneficial difference to the disease or condition it is treating before it can be made available to the public.
Sponsors
Companies that plan, fund and initiate clinical trials are known as sponsors. A sponsor may be a hospital, pharmaceutical, medical device or biotechnology company, or another organisation interested in improving medical practice standards.
The company that has developed and/or owns the new treatment will plan clinical trials in order to test the effectiveness of the treatment. Health professionals who are not employed by the company that owns the treatment are usually approached to manage the conduct of a trial. This ensures that trials are conducted in established health care facilities.
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Human Research Ethics Committee (HREC) Review
Before a trial can commence, it is first reviewed by one or more medical-scientific ethics committees. Medical-scientific ethics committees examine the planned clinical trial in terms of safety, treatment type and duration, plans for continuation of treatment after the trial finishes and other ethical considerations. The medical-scientific ethics committee will only approve a trial once it is satisfied that it has been appropriately planned in regard to all of these aspects and it will ask for adjustments to the trial plan if warranted.
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What can I expect?
First you must qualify for a trial by meeting certain ‘inclusion criteria’ which may include specifications regarding characteristics such as age, severity of illness, medical history, and recent health. By specifying such criteria, researchers are better able to answer the research questions that are being asked in the trial.
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Monitoring
If you agree to participate in a clinical trial you commit to certain responsibilities that are expected of you in return for your inclusion in the trial. All clinical trials involve close medical supervision and most involve regular pathology testing. This close supervision is sometimes referred to as monitoring. It is important that you keep all appointments that are planned for you so that the researchers can collect the required amount of information for analysis. If you miss appointments it is possible that not enough information will be collected about your condition and your data may not be complete enough for inclusion in the final analysis. Such a situation can jeopardise the trial as a whole in some cases.
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Randomisation
Depending on the trial, you could be randomly assigned to a treatment group. In some cases even the researchers will not know what treatment you are receiving until a specified time. By this method researchers eliminate bias so that measurements taken represent the true effects rather than the expected effects. Most trials involve randomly assigning patients to either a group who will receive current standard treatment/s or to a group who will receive the experimental treatment that is being studied.
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Placebos
Some trials will randomly assign patients to either a group who will receive the experimental treatment or to a group who will receive placebo when no effective treatments are available to compare with the new treatment. A placebo is an inactive treatment that has no effect.
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