Frequently Asked Questions

Select from the groups of frequently asked questions below

About clinical trials questions and answers

What is a clinical trial?

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.

Who can participate in a clinical trial?

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.

Are clinical trials safe?

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.

Does every new medicine need to be tested in a clinical trial?

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.

Why are some trials for healthy volunteers?

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.

Will there be any long-term effects?

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).

What will happen with the results?

Study results will be published in scientific journals or trial websites once all the clinical phases of a trial have been completed.

Will I be paid for taking part in a healthy volunteer clinical trial?

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.

Will I be paid for taking part in a patient clinical trial?

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).

Registration questions and answers

Are you currently looking for participants?

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.

What does volunteering mean?

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.

How do I express interest in your clinical trials?

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.

What happens after I register my interest on this website?

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.

Eligibility questions and answers

What are the requirements to be a healthy volunteer?

You may be a suitable healthy volunteer if you are:

  • Aged 18-65 years
  • Currently taking no medication
  • Within a healthy weight range
    • A healthy weight is determined by your BMI (Body Mass Index). This is a relationship between your height and your weight. A healthy BMI is somewhere between 18 and 30.
  • Have no significant past medical history
  • Have suitable lifestyle habits
    • Some studies require non-smokers, but others allow light smokers.
    • Consumption of small or moderate amounts of alcohol, typically if fewer than 14 alcoholic drinks per week.
    • Illicit drug use is not allowed and a drug test will be given during screening and before check-in.

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!

What are the requirements to be suitable for a patient clinical trial?

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.

How do I know if I am suitable?

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.

What happens if I am not suitable for a specific trial?

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.

During a clinical trial questions and answers

How much time commitment is required from me?

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.

Do I have to stick to the trial dates?

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.

Can I bring my own food into the unit?

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.

Can you cater for specific dietary requirements e.g. vegetarian, vegan, halal, and food allergies?

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.

What do I do to keep myself entertained whilst I’m in the unit?

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.

Can I leave the clinic during the in-house period of a trial?

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.

Can I have visitors?

Yes. Visitors are permitted but only by arrangement with the study staff.

Can I smoke in the clinic?

No. Smoking is not permitted on the entire hospital grounds.

Can I do laundry?

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.

Do I need to bring towels and linen?

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.

Can I make phone calls and/or can I use my mobile in the clinic?

Yes.

Do you have Foxtel or Netflix subscriptions?

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.

Is there parking at the hospital?

Yes. Parking is operated by Metro parking and the parking rates are here.

Are there lockers for my belongings?

Yes.

Do you have computers to use?

No, you have to bring your own devices. But free wireless internet is available.

After a clinical trial questions and answers

When do I get paid?

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.

What happens to my medical/personal information?

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.

How many studies can I participate in a year?

Only 4 clinical trials may be completed in one calendar year, per participant. There may be other restrictions depending on the specific trials.

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