What you need to know about clinical trials, before you start considering one.
If you are ever considering taking part in a clinical trial, always make sure: you understand what the trial is about, why you are being asked to take part and what you will need to do if you do consent to take part; you have been informed of and considered the risks and benefits of taking part, and how
There are alot of rules around how to run clinical trials, based on international guidelines and local country regulations. The International guidance for how clinical trials are run is known as Good Clinical Practice (ICH-GCP). These guidelines set out the responsibilities of ethics committees, researchers, sponsors and monitors of trials, the records that should be kept and the details around
Clinical trials are usually conducted in clinics where the researchers work. This might be GP or primary care physician offices, hospital clinics or departments, specialist clinics, and may be private or public institutions. Trials can be “single-centre” (run at only one clinic), or “multicentre” (run at many clinics at the same time). Multicentre trials may be done in just one
The terms phase I, II, III and IV are usually used when there is an drug being tested. There can be multiple trials in each phase. The phases usually follow one another, but can sometimes overlap. Decisions will be made at the end of each trial whether to continue testing the treatment. Let‟s consider the treatment being test is called
Why? Different people have different reasons for volunteering for clinical trials. You might like to take part to have a more active role in your own health, get personal medical attention from the researchers, obtain expert medical care, gain access to new treatments early, or help others in the future by contributing to the advancement of medical knowledge. One
There is no guarantee of 100% safety by taking part in a clinical trial, because the purpose of clinical trial is to establish safety and whether the treatment works for a particular condition. A researcher would never ask you to take part if they thought the risks outweighed the benefits, nor would an ethics committee approve the trial. Ethics
We provide some information on finding trials on our Find Trials page. If you are still unsure and would like some assistance, please contact us to discuss how we might be able to help.
Randomisation is…? Randomisation is the technique that researchers use to try to prevent bias. in results that could be introduced if a patient or researcher could choose which treatment group to assign a volunteer to. The theory is that by randomly assigning volunteers to different treatment groups, where each treatment is theoretically as good as each other, you reduce the
It is important to ask questions before deciding to join a clinical trial. Researchers expect that you will have questions, so you should not be worried about asking. No question is a silly question. It would be far worse to take part in a trial that you did not fully understand. Some questions people might like to ask the researchers
Every trial has a list of eligibility criteria that outlines who will be suitable (or eligible) to take part. You may see this list referred to as the “Inclusion/Exclusion Criteria”. These lists are important for the safety of the volunteers, and reliability of the data from the trial. The clinical trial registers available online will usually list the main trial