What Is A Clinical Trial?
Frequently Asked Questions
There are many benefits to being involved in a clinical trial, but the most important is the contribution you will be making to science and research.
Without volunteers, many drugs could never be approved for general use. We are grateful to everyone who volunteers.
Below will answer any questions you may have regarding a clinical trial.
Clinical trials are research studies involving people. They test ways to treat and prevent disease.
The design of a clinical trial ensures that the results have not been influenced by any factors such as the interpretation of test results, or selection of patients into a particular treatment group.
All of today’s standard treatments for lung disease are a result of clinical trials completed many years ago.
Organizations, particularly drug companies, looking for better treatments for lung disease are the usual bodies that develop and fund clinical trials. Our Clinical Trials Unit is then contracted to conduct the trial.
Every trial has a person in charge, usually a doctor, called the Principal Investigator.
All clinical trials conducted by our team have been registered with the Australian Therapeutics Goods Authority and have received ethics approval from an approved Human Research Ethics Committee. In addition, we scrutinize the study design and do not participate in any trials unless we are completely happy with it.
Patient participation in clinical trials is completely voluntary, the patients are free to withdraw if they choose to.
Every trial is different. If you are accepted on to the trial, most involve either regularly taking either an active drug or a placebo. Most trials are ‘double blind’, meaning neither you, nor the nurses know whether you are receiving the active drug or not. After a time, lots of trials that have had positive results become ‘open label’ which means everyone who was previously taking a placebo will receive the active drug.
The benefits to your health are very positive whether you are on the active drug or not. Regular health checks by health professionals mean you have more personalised and regular care, and most of the our patients report an increase in the management of their conditions and better wellbeing as a result of their increased healthcare.
Volunteering for a clinical drug trial is a commitment, but the positive health benefits certainly outweigh any inconvenience – and all expenses are paid.
Each clinical trial has certain criteria that a volunteer must meet to be included in that trial. This can include:
- Medical history
- Current health
- Disease severity
- Ability to comply with the study protocol
Criteria for eligibility differ from trial to trial, and is listed with the trial information in Our Trials. Generally we have enough clinical trials available, that we can find a suitable trial for everyone who volunteers.
Although there are risks with any treatment, there are also many benefits from taking part in a clinical trial, including:
- Access to promising new treatments that are only available in a clinical trial.
- The treatment being studied may be better than the standard approach.
- You are followed very closely by a research team that is made up of doctors and other health professionals.
- You may be the first to benefit from the new method.
- Results from the study may help others in the future.
All clinical trials have risks, because any medical test, drug or procedure has risks.
The risk may be greater in a clinical trial because some aspects of any new treatment are unknown. This is especially true of phase I and II clinical trials, where the treatment has been studied in fewer people.
In our trials, we assess all patients for suitability for the trial, and if we feel that participation in the trial may endanger your health, then you would be advised not to enrol.
Close monitoring is the hallmark of all clinical trials, and allows any adverse effects of the treatment or unexpected deterioration in health to be detected early and steps taken to cease treatment or give additional care.
New drugs or treatments may not be any better than the standard care they are being compared to.
If you are in a randomized trial, you will not be able to choose if you are getting the new treatment, the standard approach or a placebo.
The ultimate purpose of a clinical trial is to answer a medical question, but every effort has been made to understand and reduce the risks during pre-clinical and earlier clinical studies.
Each clinical trial is designed differently:
- Some trials compare one treatment to another.
- Some compare active treatments to a placebo.
However, clinical trials on people with lung disease must also be designed to allow participants to use medication to relieve their symptoms, so that receiving placebo will not endanger your health.
Unfortunately neither you nor the doctor can choose which treatment you get on a trial.
As much as possible, all of your personal and medical information will be kept confidential.
Of course, your health care team needs this information to give you the best possible care, just as they would if you were not in a clinical trial.
Medical information that is important for the study, such as test results, is usually put on special forms and into computer databases. This is then given to the people who will analyze the study results.
Your information is assigned a number or code — your name is not on the forms or in the study database.
Sometimes, members from the research team or from the Food and Drug Administration may need to look at your medical records to be sure the information they were given is correct. But your personal information is not given to them and is never used in any published study results.
- Ring our friendly staff on 08 6457 3198 or complete the online form, and let them know you’d like to be considered for a trial.
- Answer some questions to be put on our database, so we can contact you when the trial or any future trials are ready to recruit.
- If you are suitable for the trial, we will send information about what is involved and an appointment will be made for you to come in and meet the nurses.
- At your meeting (depending on the trial) you will undergo some tests, for example breathing tests and completing questionnaires.