What is a Clinical Trial or Clinical Study?
Clinical trials are where new drugs and devices are tested in people, to see whether they are safe and effective. Clinical trial research is conducted by experienced medical staff. All clinical trials must be approved by an independent Ethics Committee that monitors the conduct of the trial.
All pharmaceutical treatments in use today had to be proven effective and safe in clinical trials before they could be made available for widespread use within the community.
By the time a study treatment gets to a stage where it is given to patients in clinical trials, it has been thoroughly researched in the laboratory.
Why do people take part in Clinical Trials?
Participation in clinical trials is completely voluntary. People enrol in clinical trials for various reasons. Some people are interested in assisting in finding a new treatment for a disease. Some people are interested in receiving investigational research medication that is not available to the public.
Clinical Trials provide volunteers with a free thorough medical examination (or Medical Screening). Most Clinical Trials provide a financial reimbursement to compensate for volunteer’s time and inconvenience.
What are the different phases?
Phase I Studies:
Phase I research studies include first time in human studies, previously this drug or treatment has been tested in animals. These trials are usually first conducted with ‘healthy’ volunteers (this is someone with no pre-existing medical condition).
This initial phase of testing in humans is done in a small number of healthy volunteers (around 20 to 80). The study is designed to observe what happens to the drug in the human body. For example, how it is absorbed, metabolized, and excreted.
In a first time in human study the initial groups (or cohort) of volunteers receive doses of the drug that are very low, lower than would be given to people as a treatment. When the results of a dosed cohort have been analysed a decision is made as to the safety of then increasing the dose of the drug for future cohorts. A Phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months.
Phase II Studies:
When Phase I studies are successfully completed, the investigational drug may be tested in Phase II studies.
During Phase II studies, the investigational drug is tested for its effectiveness. Most Phase II studies are randomized trials. This involves one group of patients receiving the experimental drug, while a second “control” group will receive a standard treatment or placebo (drug containing no active ingredient).
Often these studies are blinded, this is where neither the patients nor the researchers know who is receiving the experimental drug, or who is receiving the placebo. This is so that the study can provide a comparison between the relative safety and effectiveness of the experimental drug.
This second phase of testing may involve up to several hundred patients.
Phase III Studies:
Most Phase III studies are randomized and blinded trials. The drug is usually tested in several hundred to several thousand people, this is so that researchers are provided with a more thorough understanding of the drug's safety, effectiveness, benefits, as well as the range of possible adverse reactions.
Once a Phase III study is successfully completed, it can be requested that the drug be approved for availability to general public.
Late Phase III/Phase IV Studies:
In late Phase III/Phase IV studies, studies often compare an investigational drug with other drugs already available on the market. This is called a “bio-equivalence study”.
Some late phase studies are designed to monitor a study drug's long-term effectiveness as well as the impact on a patient's quality of life. Others are designed to look at the cost-effectiveness of an investigational drug therapy relative to other traditional or existing treatments.
Is your Doctor involved?
We encourage you to speak to your own Doctor about your interest in taking part in Clinical Trials. With your approval, we can correspond with your Doctor regarding studies that you may be interested in taking part in.
Taking part in a study How to get involved.
You can find out information about studies that Centre for Clinical Studies (CCS) is conducting by:
- Registering for our subject database. This enables us to contact you via email or post in relation to studies that you may be eligible for.When you register there is no obligation to take part in a study, it simply means that we are able to contact you.
- Looking at Study Briefs on our website. This provides you with basic information about the study so that you can determine if you meet the inclusion/exclusion criteria and can commit to the time requirements.
If there is a study that you are interested in taking part in you should contact the CCS Recruitment Officer on 1800 243 733. If it is the first time you have contacted CCS you will be invited to attend a tour of the Clinical Trial facility. Attending a tour of the facility will give you a better understanding of what’s involved in taking part in Clinical Trials, it is an opportunity to meet some of the staff as well as ask any questions.
If you have identified a Clinical Trial that you are interested in taking part in, the Recruitment Officer will ask you some study specific inclusion criteria questions over the phone. This is to lesson the potential of you being excluded by a condition that you are currently aware of.
If you meet the study specific inclusion criteria a medical screening appointment can be scheduled. Before you attend a medical screening you will be asked to read through a Patient Information and Informed Consent (PI&IC) form.
The results of the medical screening determine whether you are eligible to take part in a particular study. At the medical screening a Doctor will discuss the Clinical Trial with you to make sure you fully understand what the study is about. If you are willing to take part in the study you will be asked to sign a form to consent to taking part in the medical screening.
The medical screening involves a general physical examination, for example:
- A review of your medical history.
- Measurement of your height and weight and blood pressure.
- A physical examination.
- An ECG (a test to measure the electrical activity of your heart).
- A collection of blood and Urine samples (for clinical testing).
- A drug and alcohol screening.
- A Pregnancy test (for females)
When the results of the samples collected are returned, and the CCS Medical Officer has reviewed them. You will be notified of your eligibility for the study.
