Select from the groups of frequently asked questions below
Select from the groups of frequently asked questions below
Clinical trials are research studies that explore whether a medicine, treatment, or device is safe and effective for humans. These studies also may show which medicine, treatment or device works best for certain illnesses or groups of people.
We recruit healthy volunteers and patients. Healthy volunteers are typically between 18 and 65, take no medications and are generally healthy. Patient clinical trials generally include people with a specific medical condition. The eligibility requirements usually vary between each trial. Any participation is voluntary and each trial has requirements as to who can enter the trial.
All clinical trials are carried out under supervision of qualified doctors, nurses and other research professionals. Every clinical trial is evaluated and approved by an independent Human Research Ethics Committee (HREC) and acknowledged by the Therapeutic Goods Administration (TGA), before the trial can go ahead. All clinical trials have some risk. Before you consent to participate, you will be given information about the trial to read. You will have time to discuss potential risks and any concerns you have with the study doctor. You can also discuss the study with your family, friends and/or your GP before making any decision. Before you can take part in a trial, you will undergo a thorough medical examination including blood tests, tracing of your heart rhythm, and blood pressure measurement. This is done to ensure that your safety always comes first.
Yes, every medicine must undergo clinical trials before approval for use in Australia. Clinical trials tell us whether a new medicine is safe, whether it works, how well it works, and whether there are any side effects. Clinical trials are critical to help us develop new and better medicines.
Healthy volunteers have no medical problems and do not take any medications on a daily basis. Therefore, when we study a medicine we can see effectively how the drug is absorbed and excreted by the body, without having other medications interfere with this.
Every clinical trial is different, as are the possible risks and side effects. Any information we have available will be detailed in the study-specific participant information and consent form (PICF).
Study results will be published in scientific journals or trial websites once all the clinical phases of a trial have been completed.
Yes. You will be compensated for the time you spend with us if you are eligible to participate. The amount will vary by trial but is generally calculated based upon the amount of time involved and the number of visits to the clinic.
This varies by clinical trial. Reimbursement information will be given to you upfront when you first speak to us, and also contained in the Participant Information and Consent Form (PICF).
Yes. We are always looking for participants for clinical trials. We conduct healthy volunteer clinical trials all year round. If you are a patient with a medical condition, register your details with us and we will contact you at the right time.
As a volunteer, you will be added to our database and as suitable trials begin recruitment, we will email you to let you know. Your time is volunteered to help us with our research but you do get paid for helping out.
You can fill in the registration form on this website or call us directly. We will ask some basic medical questions to determine if you are suitable for our clinical trials. Your details will be added to our volunteer database (with your consent) and you will be sent relevant study information based on your profile.
Our staff will be in contact with you to answer your questions and if you would like, to assess your suitability for a current trial.
Before any procedures can be performed, your study doctor will discuss with you every aspect of the study and you will have the opportunity to ask any questions that you may have. Once you have made the decision to participate in the trial you will be asked to sign the Participant Information & Consent Form (PICF). The PICF provides you with detailed information about the trial, including all procedures and known risks, so that you can make up your own mind whether you want to take part or not. You will be given a copy to keep for your records.
Yes. You will have several opportunities to ask questions. First, you will discuss the trial with our recruitment team by telephone and you can ask questions. Next, you can choose to attend a screening appointment where you will speak to a doctor. The doctor will answer any questions you may have. You will also be given a Participant Information and Consent Form (PICF) to read when you arrive.
Each clinical trial has its own PICF. The PICF will explain:
The PICF should be written in plain English. However, there may be parts you wish to clarify with the doctor before you decide if to participate.
Yes. You are free to withdraw consent for a study or the volunteer database at any time. You do not need to provide a reason if you do not want to.
Once enrolled in a study you are issued with an alert card. This card contains all contact numbers for the study.
You may be a suitable healthy volunteer if you are:
This list is general in nature and exact requirements will vary study to study. Don’t worry if you are not eligible to participate in one study, as we will have many more!
This varies between trials. You will have at least one specific medical condition, such as diabetes or rheumatoid arthritis. You might already be getting treatment for your condition or you might not. Speak to us about specific clinical trials for your condition.
We will assess you in two stages – firstly over the phone and later in person at a screening appointment. Initially, you may be interviewed over the phone to assess your suitability. In order to determine suitability, we look at such things as your age, your height and weight (to help us estimate your body mass index), medical history, and gender. Each study has different selection criteria. If you are suitable to screen for a study, you will be required to attend the clinic for a medical review. Based on the results of this screening visit we can determine whether you are eligible for the study.
Each trial has specific selection criteria. If you are unsuitable for a particular trial, we can provide information on other trials that you may be suitable for. This is done via email when we commence volunteer/patient recruitment for new trials.
This will vary from trial to trial. Most trials require a commitment in some form or other over a 3 month period. This is from the first screening appointment until the final follow-up visit. This does not mean that you are with us for 3 months. Each trial has a designated calendar with specific dates on which you will need to visit us or receive a phone call from us. Most trials require that you stay with us for several consecutive days in addition to frequent out-patient visits which can vary in duration from 30 minutes to several hours.
Yes. If there are specific dates or times you have difficulty with, tell us before you begin the trial. We may be able to look at other groups or trials that suit your schedule better.
No. The meal times and content of meals on our trials are very strictly controlled. That’s why we will provide all your meals for you during your stay in the unit.
That depends on the nature of the study and the type of requirements/allergy you have. There are some conditions (e.g. coeliac disease, severe nut allergy) which we usually cannot cater for – although there are exceptions to this rule. So, please tell us straightaway if you have any allergies or dietary requirements, and we will discuss those with you.
We have recreational facilities that include: TV lounge, dining room, DVDs, gaming consoles and free wireless internet. These can be used whenever you have free time and not required for trial tasks. Feel free to bring in your own devices, books, craft etc.
No. While you are in-house, you may be able to have visitors and make phone calls but not leave the building. You’ll need to participate in various assessments and monitoring so during this period we need you to stay on site. You will be closely monitored and supervised by our nurses and trial doctors.
Yes. Visitors are permitted but only by arrangement with the study staff.
No. Smoking is not permitted on the entire hospital grounds.
No, you usually are required to bring sufficient change of clothing for the in-house period. For longer trials where this is not practical, we will discuss with you alternative arrangements.
No, towels and all bedding are provided. You will need to bring your personal toiletries and clothes for the length of your stay. There is no need to wear a hospital gown. Shoes must be worn at all times while walking around the unit.
No. We don’t have Foxtel, with only standard ‘free to air’ channels are available. We do have WIFI but you will need your own Netflix account.
Yes. Parking is operated by Metro parking and the parking rates are here.
No, you have to bring your own devices. But free wireless internet is available.
Payment for the trial will be discussed on a trial-by-trial basis. For some trials, payment is made by cheque at the end of a trial once the trial and all follow-up visits are complete. For other trials, reimbursement will be made at regular intervals during participation.
We take privacy very seriously and do not disclose your information to any third parties. All your information will be treated as confidential (i.e. any information that identifies you will be kept securely). Access to this information will be limited to authorised personnel working at the Scientia Clinical Research and possibly to representatives of regulatory authorities. Scientia Clinical Research will protect your information in accordance with the current law.
Only 4 clinical trials may be completed in one calendar year, per participant. There may be other restrictions depending on the specific trials.