WHAT YOU NEED TO KNOW ABOUT CLINICAL TRIALS?
Hundreds of thousands of people in the UK volunteer to participate in clinical trials every year.
Clinical trials are not just conducted to test medicine, they are also used to test and compare lots of different medical treatments, products and equipment such as surgical tools, diagnostic machines, wound dressings and mental health therapies. Even the humble plaster has been subject to clinical trials!
Participating in a clinical trial has numerous benefits for volunteers, who are helping to develop new treatments and playing an active role in research; importantly, volunteers are benefiting future generations, as well as taking control of their own health. Our current high medical standards are due to rigorous clinical trials that have taken place, giving medical professionals the scientific base for more accurate diagnosis and safer treatments for all of us.
Why do we need to do clinical trials?
Clinical trials are essential for progressing our knowledge of any given disease and for the development of new treatments. Clinical trials assess whether the particular medication is safe, has any side effects and if it works effectively. Clinical studies are designed to improve health and optimise the quality of life for people affected by a given condition. With every research study conducted we get closer to unlocking new treatments and understanding more.
What is Phase 1, Phase 2, Phase 3 of a clinical study?
Phase 1 is the very first stage of a clinical trial, whether the medication is tested on a small group of volunteers, for researchers to understand the safety.
Phase 2 is the second element of the study and will test the medication on a larger group of people to determine its safety, side effects and positive effects it is having on treating the condition.
Phase 3 clinical trials. These are randomised studies where the participants are divided into two groups;
1) The Control group: participants in this group are given the active medication
2) The Placebo group: participants don’t receive the active medication
Phase 3 clinical trials test the medication on much larger groups of people and sometimes there may be more than two groups.
Why do some people receive placebo medication?
The placebo drug will look identical, or very similar to the active medication, but does not contain the active ingredients. This is to test responses to the placebo treatment so the study can identify if the treatment is having any real benefit, or if they are improving or feeling better because individuals in the study are taking positive action and want to believe it is working.
Do people in the placebo group get to have the active medication after the clinical trial?
In most Phase 3 studies, all participants will have the opportunity to take the active medication. After an initial period when a patient may have been on the placebo arm of the trial, all patients will then have a follow on period called the Open Label Extension period, during which all participants have full access to the active study drug, with no chance of placebo. This happens as long as the results stay positive and the patient can continue to attend the research centre to be checked over by the study team. Not all studies have these Open Label Extension periods, but it is rare for a trial not to include this, especially in neurodegenerative condition studies.
What is a blind trial?
Participants are not told which group they are in, so they won’t know if they are taking the active medication, as this may influence how they are feeling or reporting symptoms.
What is a double-blinded trial?
This is when the doctors and the medical teams also don’t know which group the volunteers are in.
How do I get involved?
Re:Cognition Health is a world-leading centre for conducting clinical trials and has been the recipient of many prestigious awards, including 2 which have recognised the Company for its invaluable impact on society.
To register your interest and to find out about trials currently available simply contact a member of our team at Re:Cognition Health on 0203 355 3536