Information for patients, carers and the community
Frequently Asked Questions
What is research?
Research is the activities undertaken to advance knowledge for the good of society; to improve the health of people worldwide; or to find better ways to treat and prevent disease.
What is a Clinical Trial?
The World Health Organisation defines clinical trials as follows:
“For the purposes of registration a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Clinical trials are a method of investigating better ways of managing disease and are an essential component of developing new treatments, drugs or interventions. Trials can test experimental medicines, vaccines, medical devices, behavioural therapies or lifestyle factors e.g. dietary changes, to name a few. New medicines are being developed every day. Without clinical research many of the modern interventions of today would not be available.
Find out more:
What do Clinical Trial phases mean?
Phase I Clinical Trial
Phase 1 clinical trials are done to test a new biomedical intervention for the first time in a small group of people (e.g. 20-80) to evaluate safety (e.g. to determine a safe dosage range and identify side effects).
Phase II Clinical Trial
Phase II clinical trials are done to study an intervention in a larger group of people (several hundred) to determine efficacy (that is, whether it works as intended) and to further evaluate its safety.
Phase III Clinical Trial
Phase III studies are done to study the efficacy of an intervention in large groups of trial participants (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions (or to non-interventional standard care). Phase III studies are also used to monitor adverse effects and to collect information that will allow the intervention to be used safely.
Phase IV Clinical Trial
Phase IV studies are done after an intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use over longer periods of time. They may also be used to investigate the potential use of the intervention in a different condition, or in combination with other therapies.
How do I find out what trials are available to participate in at SCHHS?
You can visit each of our departmental research pages from the current research or clinical trials homepages for an overview of the studies that are currently being conducted. A national database of available clinical trials listing the sites where they are being conducted can be found here.
Please note that currently, all participants in clinical trials at SCHHS are recruited by doctors from patients attending the hospital and not from external volunteers.
Please speak to your doctor if you think you have a condition that fits with a current clinical trial.
I am already involved in a SCHHS Clinical Trial or Research project and have a question – who should I ask?
Contact your doctor. You should have been supplied with a patient information sheet or card containing the contact details of your trial team when you agreed to take part in the study. If you have lost this information, call your doctor and they will resend you a copy.
I am in a Clinical Trial but cannot make my next appointment – what should I do?
If you are unable to make your next clinical trial appointment as scheduled, please check the paperwork you were given for the contact details of the nurse supporting your study. If these are unavailable, contact your doctor.
I am concerned about an adverse reaction that may be related to my participation in a research study, what should I do?
You should contact your doctor immediately and describe your symptoms. You may be requested to attend your GP or the hospital. Please take with you all the information you have about the research study or clinical trial that you are involved in.
In the event of an emergency, always dial 000 immediately.
If you are admitted to hospital for any reason while participating in a clinical trial, ALWAYS inform your treating doctor that you are involved in a trial.
I have a friend or family member who is on a Clinical Trial – how do I find out more about it?
I identify as Aboriginal and Torres Strait Islander, is there anything else I should know?
If you are being asked to participate in a clinical trial, please mention that you identify as Aboriginal and Torres Strait Islander, as there may be additional support available to you.
If you are participating in a clinical trial and would like to have a member of the Aboriginal and Torres Strait liaison team be present at your appointments, this can be arranged. Please let your doctor know.
Please visit the SCHHS Aboriginal and Torres Strait Islander Health Service page for more information about Aboriginal and Torres Strait Islander health services at SCHHS.
Does SCHHS have a consumer engagement group specifically for research?
SCHHS Consumer Research Engagement Group (CREG)
Consumer Research Engagement Group (CREG) is a group of volunteer health service consumers and community members with an interest in supporting the research activities of Sunshine Coast Hospital and Health Service (SCHHS).
In addition to the provision of evidence becoming a compulsory component of many research funding schemes, researcher utilisation of the insight, experience and advice of consumers and community members is increasingly relevant to the development and undertaking of relevant research priorities and projects across SCHHS.
The CREG provides a mechanism for individual researchers, research groups or departments to access this valuable input.
Value of Consumer Inputs into Research
The three phases of the research process where this value is most evident are:
- The ‘Planning,
- The ‘Doing’ of research, and
- The ‘Sharing’ of research findings and the research engagement experience.
Please visit the Consumer engagement page for information about consumer involvement at SCHHS and to register your interest.