Key Inclusion Criteria:
Key Exclusion Criteria:
Clinical trials are research investigations in which people volunteer to test new treatments, interventions or medications to manage various diseases or medical conditions. Some investigations look at how people respond to a new medicine or treatment and what side effects might occur. Other clinical trials might also compare existing medications, test new ways to use or combine medications or observe how people respond to other factors that might affect their health (such as dietary changes).
Clinical trials are essential to the development of new interventions, without them we cannot properly determine whether new medicines developed in the laboratory works, if it is safe for humans, and if it is better than the interventions that are already available. Clinical trials often lead to new medication or treatments becoming available that help people with their particular condition to live longer and to have less pain or disability. Clinical trials can also help to improve health care services by raising standards of treatment.
Clinical trials are typically conducted in 4 phases. In the early phases, the new intervention is tested in a small number of participants to assess safety and effectiveness. If the intervention is promising, it may move to later phases of testing where the number of participants is increased to collect more information on effectiveness and possible side effects.
Trials can involve people of all ages, from children to the elderly, and with all types and stages of a disease or condition. Taking part in a trial is voluntary and participants can withdraw at any time with no adverse effects on the quality of their medical treatment or relationship with their doctor. Each study’s protocol has guidelines stating who can and cannot join the clinical trial. The criteria varies by study and could include your age, gender, medical history, current health status and the particular type or stage of disease you may have. Many trials need participants who have the disease or condition that the new intervention targets. Patient participants test the new intervention to see what effect it has on their disease or condition. Some trials need healthy participants to test the safety of new interventions or tests, particularly in early stage trials. In these trials, healthy participants can be compared with patient participants. Before you join the trial, you will be asked to sign an informed consent form. Then a doctor will assess your medical history, perform a physical exam and often laboratory tests to determine whether you meet the eligibility criteria.
All clinical trials have guidelines about who can take part. These guidelines are called inclusion and exclusion criteria. Criteria that must be met in order to allow someone to take part in a clinical trial are ‘inclusion criteria’. Criteria that prevent someone taking part are ‘exclusion criteria’. The criteria may be based on age, gender, the type and stage of a disease or condition, previous treatment history and other medical conditions. Inclusion and exclusion criteria aim to ensure that the trial will produce useful and reliable results and contribute to the safe conduct of the study.
The length of each study is different. The trial’s criteria document will provide you with information on how long the trial lasts and what is expected of you. You can leave the trial at any time. Even if you signed paperwork, you may still leave the study if you choose. You have the right to change your mind at any time.
If you have taken part in a trial, the researchers should make the results available to you directly (if you have indicated that you wish to know the results). It is also expected that results of all completed studies will be made available in reports or papers published in scientific journals. However, analysis of the information can take some time and there may be a delay before the results of a clinical trial are known, particularly with larger trials that can involve thousands of people and that may take place over several years.
By taking part in a clinical trial, you can contribute to the advancement of scientific knowledge and, in some cases, improved health for yourself or others with the same disease or condition. New interventions that help people to live longer, have less pain or be free of disability are only possible because of the willingness of people to participate in clinical trials.
Some of the reasons people choose to participate include:
Of course, there are potential downsides associated with participating in clinical trials. The experimental treatment may have some side effects, it may take up more of your time than conventional treatments, or the treatment simply may not be effective for you. It is important to consider these factors before participating in any clinical trial, and you should have a discussion with your doctor if you have any questions or concerns.
The QEI doctor will first talk to you about informed consent. This is a process by which you will learn the details of the trial – what is involved, the purpose of the study, the tests and procedures that will be used, and the risks and benefits. You will then be given a written participant information and consent form, which explains the study. You can ask about anything that is not clear to you or that you do not understand. You can take your time and talk it over with family and friends or your own doctor before deciding whether to take part.
Informed consent means that potential participants are given information about the key facts of a clinical trial before deciding whether or not to take part. Signing the consent document means that you are agreeing to take part in the trial and you have understood what that will involve. Informed consent also means that participants are provided with information on new developments throughout the trial. You cannot be entered into a trial if you don’t want to be. If you are asked to take part, you are free to say yes or no at any time. There should be no pressure on you to enter a trial. If you are under 18, a parent or guardian has to give legal consent and you have to give your permission as well.
For anyone interested in being part of a clinical trial at the Queensland Eye Institute, the first step is finding out more about the trial in general and what is involved. You can do this by taking the fact sheet to your Optometrist, General Practitioner or Ophthalmologist, to confirm that you meet the eligibility criteria. If they believe you do, a referral is made to our clinical trials department at the Institute. You can then contact us on 07 3239 5001 to advised that you have a referral and are interested in more information about the clinical trial underway.
You can stop taking part in a trial at any time. You may decide to stop taking part in a trial if your condition is getting worse, you are finding it difficult to participate or you have concerns about the intervention. You can also choose to leave the trial at any time without giving a reason and without it affecting the care that you receive. If you do withdraw from a clinical trial, the relationship between you and your doctor will not be affected; however, it is important to discuss your decision to leave a trial with the research team and your doctor so they can provide the correct support and advice. Importantly, if there are signs that the intervention in a trial could be unsafe, the research team or the regulators monitoring the trial will stop the trial. Also, if the new intervention is found to be clearly superior or inferior during the trial, the trial may be stopped to reduce the number of people who receive the less beneficial intervention.
Based on material provided by the National Health and Medical Research Council.