- What are Clinical Trials?
Clinical Trials are a vital part of medical research. They are rigorously controlled tests of a new medication on human participants and enable new medicines to be developed and improved to treat patients around the world.
- What Are The Benefits For Me?
If you participate in a clinical trial you will gain access to new research treatments before they are widely available, and help others by contributing to medical research. For most trials you will be reimbursed for out of pocket expenses such as travel costs. You will also receive regular checks and medical tests that do not cost you anything.
- Are Clinical Trials Safe?
Every clinical trial must adhere to strict protocols and procedures. Before the trial can commence these must be approved by the HDEC (Health & Disability Ethics Committee) and SCOTT (Standing Committee on Therapeutic Trials). The aim of this to protect patients and ensure there are not unnecessary risks. Throughout the trial all patients are closely monitored and followed by trained study staff and doctors.
- How old to I have to be?
The minimum age is 18 for our trials. Different trials will have different restrictions depending on what is being tested.
- Who Looks Out For My Rights?
We believe the most important thing in clinical trials is patient rights and wellbeing. All research is carried out in accordance to FDA (U.S. Food and Drug Administration) standards. New Zealand’s Health and Disability Ethics Committees (HDECs) must also review all the research documents (e.g., the protocol, the investigators brochure and consent form) and procedures that impact the rights and welfare of the subjects of the proposed research to ensure it meets or exceeds established ethical standards determined by the National Ethics Advisory Committee (NEAC). Clinical research assistants from the sponsor visit us regularly to ensure we are complying with all the regulations. They also monitor the data we collect to make sure it is accurate. The doctors (the ‘investigators’) must conduct the study in accordance with Good Clinical Practice (GCP) and all applicable laws, regulations and guidelines.
- What are the risks?
There are always potential risks being involved in clinical trials. These will be explained to you during the consent process before you take part and you will have plenty of opportunity to ask questions. You will not be able to take part unless you have given written consent to ensure you are fully informed. Some medicines are well understood and are unlikely to cause side effects. However some of the medicines that are being trialed do not have everything known about them and there is the possibility of new side effects, which may be mild, moderate or even serious.
To us, your safety and wellbeing is the most important thing at all times and if you or the doctor think it is unsafe for you to take part or continue, you will be removed from the study immediately and treated appropriately.
- Will I get paid?
Some studies may provide a payment in recognition of your time and inconvenience. However you will be reimbursed for all study related expenses e.g. travel costs.
- What will I have to do on a clinical trial?
Each trial is different but before you start a trial you will be given information about the trial including what the treatment is, what tests will be done, and when you will need to visit the clinic. Once you understand what is involved you will need to sign a consent form. This confirms you understand what is involved in the study. After this you will be screened by the research staff and a doctor to ensure you are eligible. If you are eligible you will be enrolled in the study.
- Will the study medication work?
Most trials involve giving some patients a placebo. This means you might not receive any active treatment and we cannot guarantee you will get better. You will however be carefully evaluated throughout the study.
- How Can I Become A Study Volunteer?
Making the decision to participate in a clinical trial is a very personal decision. It can be helpful to talk to friends, family members or a doctor.
If you are interested in participating in a clinical trial please click here to register your interest in participating in a clinical trial. Your enquiries will be kept confidential.