Participating in
a Clinical Trial

What is a Clinical Trial?

A clinical trial is a type of research that tests new, or existing, medical treatments to determine if they are of any benefit. Every medication that is on the market today has gone through a clinical trial.

Phases of a Clinical Trial

Phase 1

Test a new drug for the first time in a small group of people

Phase 2

Study the drug in a larger group of people to assess the safety and to determine a suitable dose

Phase 3

Compare the drug to other standard drugs in large groups of people to determine inferiority or superiority

Phase 4

Search for other diseases the drug can be used for and monitor longterm benefits and risks

Your Safety is Our Priority

Clinical trials are rigorously regulated for safety, requiring informed consent and frequent healthcare reviews

  • There are several bodies involved in regulating clinical trials, including the Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA), European Medicines Agency (EMA) and Human Research Ethics Committees
  • Regulatory bodies ensure that drugs developed for clinical trials have all gone through the relevant testing for safety before they can be tested for efficacy
  • Human Research Ethics Committees review all human clinical trials in Australia to ensure that the trial will be conducted ethically, all trial participants’ safety is maintained, the trial is being conducted for scientifically or medically required reasons and that the integrity of the trial data will be maintained
  • At all times, the benefits are assessed to ensure that they outweigh the risks

  • Made up of experts on the condition related to the trial
  • Often contain an independent person not linked to the trial sponsor or site personnel conducting the trial
  • Supervise the trials and review all safety data to ensure that benefits continue to outweigh the risks
  • Perform periodic reviews of trial results to determine if the trial is still safe to continue

  • Nothing in a clinical trial is done without obtaining written, informed consent
  • This involved you being provided with the Participant Information and Consent Form (PICF) with enough time to read this and speak to your usual treating doctors and relatives/friends about the trial. You are encouraged to write down any questions you have, so the study team can discuss these with you at your first visit
  • The PICF is a document that goes through what the trial is testing, what is known about the drug so far, what is required of you throughout the trial and what tasks will be done during clinic visits, what potential side effects can occur and what your rights as a trial participant are
  • You are encouraged to write down any questions you have so the study team can discuss these with you
  • Once you attend the screening visit, a doctor will go through the PICF with you and answer all your questions. If you are willing to proceed with participating in the trial, you will be asked to sign and date the PICF and the doctor will also sign and date the document. You will be given a fully signed copy to keep for your records

  • Each trial is different, but all trials have reviews to assess you for safety and how the drug is working
  • At your health care review appointments, you will be seen by study staff who will perform checks as per the requirements of the clinical trial
  • Clinical trial health care reviews are often more frequent than usual standard of care appointments but this is to ensure you are regularly checked for safety and to ensure you are suitable to continue on the clinical trial
  • This allows you to discuss your health with study staff regularly and we can provide updates to your usual treating doctors as required
  • All review appointments are performed at no cost to you and your travel costs for trial appointments are reimbursed

  • Clinical trials are completely voluntary from start to finish and you are not obligated to stay on the trial if you no longer wish to after you have signed the PICF
  • If you commence the clinical trial and then withdraw, your relationship with Emeritus Research is not affected and there are no penalties for withdrawing from the clinical trial
  • Your usual healthcare will not be affected
  • In the case that you withdraw and you have received one or more doses of the study drug, we would ask if you would be willing to complete a safety follow-up visit for a final check on your health and to discuss your options after leaving the clinical trial
  • You can still participate in future clinical trials if you withdraw from a clinical trial, but your eligibility will need to be assessed again for any new clinical trials

The thought of joining a Clinical Trial can be daunting. Let our professional and friendly team guide you through the process. Without volunteers like you, we would not be able to facilitate the development of new therapies to alleviate the sometimes debilitating symptoms of medical conditions affecting many people throughout the world.

What to expect when participating in a Clinical Trial

  • A thorough screening process to determine eligibility
  • Multiple visits to monitor your health & safety
  • Blood tests and other pathology specimen collections
  • Procedures to monitor your progress, such as: ECGs, x-rays, physical examinations, joint counts and skin assessments (study dependent)
  • Surveys to be completed to tell us how you are feeling
  • Professional and caring staff to support you throughout your trial duration
  • Satisfaction for contributing to medical advancements
  • Positive personal experiences

Benefits of enroling in a Clinical Trial

  • Gain access to leading specialists and experienced investigators conducting our trials
  • Medications and clinic reviews at no cost
  • Receive payment for your travel costs and time
  • Work with a dedicated clinical research team
  • Make an impact on medicinal advancements

Frequently Asked Questions

Anyone can volunteer for a trial however each trial has specific requirements for who is allowed to enroll. This will be discussed with you prior to your appointment and during your first visit.

There are many reasons that people choose to join a clinical trial. These include:

  • Gain access to leading specialists and experienced investigators conducting our trials
  • Medications and clinic reviews at no cost
  • Receive payment for your travel costs and donated time
  • Work with a dedicated clinical research team
  • Make an impact on medicinal advancements

You may be paid for any time and travel costs that you incur as a result of your participation in a trial. The amount you receive will vary depending on the study. Talk to your study doctor for more information.

Your eligibility for a study will be assessed by phone calls and a Screening visit where you will see a dedicated study doctor. Once you have been determined as eligible for a study, you will come in for your first dose of study medication. The study doctor and coordinator will be monitoring for any side effects that may occur. Your visits will then follow a schedule that is determined by the sponsor of the study. Your visits may involve things such as a physical exam, vital signs, blood tests, ECG or filling out questionnaires. Every study is different, so ensure to read your PICF for more information.

The length of the clinical trial will be outlined in your PICF. You can choose to stay on study for the duration of the trial, or you are free to withdraw at any time.

Your Screening appointment will help the study staff determine whether you are eligible to continue on the clinical trial.

The appointment often involves:

  • Meet with the study doctor to discuss the study and ask any questions
  • Answer questions about your health, including medical history and any medications you are taking.
  • Measure your height, weight, and vital signs
  • Undergo a physical examination by the doctor
  • Have a blood and urine sample collected for safety testing
  • Fill out some questionnaires or surveys on your symptoms

Your Participant Information Sheet will contain a list of all procedures performed at each visit. You can ask the study staff for more information at any time.

We try our best to determine your eligibility before you come in for your screening visit, but we can’t guarantee you are eligible until we see you in person. Each trial has strict criteria for who can and can’t participate. This is to help ensure your safety.  A screening appointment will help us decide your eligibility by looking at things such as your medical history, current medications, and lab results.

Many of our trials are placebo controlled, which means that some people will receive a placebo, and some will receive the study drug. Sometimes you will receive a placebo for part of the study, and then switch over to the study drug for the rest of the study. Your study doctor will discuss this with you during your Screening visit.

Whether you receive placebo or study drug is decided by chance (like flipping a coin). In some studies the study is double-blind, which that means neither you nor your study doctor know which treatment you are receiving.  However in emergencies your study doctor can find out which treatment you are receiving.

Your study doctor will monitor your health to make sure you are doing well. You are free to withdraw from the study at any time if you feel like your condition is worsening.

Medical procedures, medicine and tests often have side effects. Your study doctor will be looking out for any side effects that you experience during the study.

Your Participant Information Sheet will contain a full list of known side effects and the frequency that they are expected to occur.

Depending on the study, you may be invited to join a long-term extension study, or you may be given compassionate access to the study medication. For some studies there is no access to the study medication once your participation is completed. For more information please read your Participant Information Sheet or speak to your study doctor.

You may or may not benefit from the experimental drug. However, your participation in a clinical trial will help patients in the future by providing more information on the study drug and how it works. Many of our clinical trials have been successful at helping bring a drug to market in Australia and overseas.

We do our best to make you feel comfortable and welcomed at Emeritus. Our facilities are bright and recently renovated, with plenty of space for you to maintain privacy during your visit. Every study has a dedicated clinical research coordinator who will remain in contact with you throughout your time on the study. Our staff are experienced and friendly and will be able to answer any of your questions.

If you have a visit that lasts for more than a few hours, we have devices for you to borrow to connect to the internet, and depending on the study, we can also arrange for meal deliveries. Talk to the study team if there is anything we can do to make your experience more comfortable.

Emeritus Research conducts trials in many different therapeutic areas, including rheumatology, gastroenterology, dermatology and many others. We run trials in all phases of clinical development.

If you are interested in participating in a clinical trial or would like more information you can register in the current clinical trials found in the top right of your screen or give us a call on 03 9509 6166 and we will be able to discuss your options with you.

Bring along a copy of your ID, and if you have it, a copy of your medical history and current medications.

In Melbourne, we are located at Level 2, 1180 Toorak Road, Camberwell, and Ground Floor, 1186 Toorak Road, Camberwell.

In Sydney we are located at Suite 2, Level 1, Building 2A, 2-12 Lord Street, Botany.

Your booking confirmation will contain more details. If you need help locating us you can call our reception staff on 03 9509 6166 or 02 8964 8186.

CURRENT CLINICAL TRIALS

We are currently recruiting for participants in the following areas.
Click below to find out more about our clinical trials and express your interest in participating