Each year, millions of people volunteer to participate in clinical studies.
Clinical studies are a key part of developing and proving new therapies and treatments for disease.
Clinical studies are research studies that are carefully designed to answer specific questions concerning the safety and effectiveness of a drug, treatment, or diagnostic method, or to find ways to improve patients’ quality of life.
Clinical studies allow researchers to find out how different patients respond to treatments while carefully monitoring the health and safety of the patients who volunteer.
All new medical treatments, including medical treatments, flu-shots and stop-smoking aids, must go through the clinical trials process before they can be approved for sale or general use. Existing treatments that may be useful in treating another condition or disease will also be available first through clinical trials.
All clinical research must be approved by a Human Research Ethics Committee before volunteers can be asked to participate. The success of clinical research, and the development of new treatments, is dependent on volunteer participation in these studies.
Are all studies the same?
Clinical studies are categorised in four different groups or ‘Phases’. As a study medication goes through each phase, researchers begin to know more about the medication, how patients respond to the medication, and any possible adverse reactions to the medication. Each phase has strict regulations about how studies are to be conducted and conditions for volunteer participation. AusTrials conducts Phase II, III, and IV studies.
- Phase I Studies are when a drug is tested in humans for the first time. The testing at this phase looks at the safety of a treatment – or any adverse side effects – as well as assessing dosing levels. These studies are generally done with a small group of healthy volunteers over several months.
- Phase II Studies test the efficacy of a treatment – or how well it works. These studies are generally done with a larger group of volunteers who have a specific illness. Usually there is one group of patients that receives the study treatments and another group that receives either a placebo or the current standard treatment for the illness.
- Phase III Studies are large scale studies often involving several thousand volunteer patients. Phase III allows researchers to gain a better understanding of the benefits and possible adverse reactions to the treatment on a larger scale and over a longer period of time. After successfully completing Phase III trials, a company can submit the study information to get approval to market the treatment.
- Phase IV Studies are conducted after a treatment has been approved for sale. Phase IV allows companies and researchers to continue to monitor the treatment, as well as evaluate how it compares to other treatments available.
Who can participate in a clinical study?
There are strict guidelines about who can participate in any clinical study. Studiesuse a criteria based on age, gender, disease type/stage, presence of other medical conditions, and previous treatment history to selectthe pollution relevantfor the study.
Sometimes in a clinical study, healthy participants are required, but other studies need people with specific illnesses and conditions to be enrolled.
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