General frequently asked questions (FAQs) on clinical trials
What are clinical trials?
A clinical trial is a health-related research study involving volunteers who are usually patients with a specific disease.
The aim of these trials is to test whether potential new treatments are effective and safe.
How can trials help stroke patients?
Clinical trials can help stroke patients in the following ways. They can:
- research ways to prevent stroke and therefore reduce the number of people who have a second stroke,
- assess the effectiveness of new treatments,
- improve the quality of life for stroke survivors.
What is consent?
A researcher cannot include you into a clinical trial without your agreement or consent, or that of your representative. Before you give this consent, the researchers must explain the aims, the treatment and the possible risks or benefits so that you are fully informed of what you are agreeing to.
It is your right to withdraw from a trial at any time for any reason. You are under no obligation to continue.
Will my information be kept confidential?
All personal information will be kept confidential unless you give permission for it to be shared with specific persons or institutions. Most research is published at some point and your results may be incorporated but they will always be anonymous.
Who is involved in setting up a clinical trial?
Many people are involved in designing and organising clinical trials. These can include doctors, allied health professionals such as nurses, physiotherapists, occupational therapists and speech and language therapists.
Each trial will follow a strict plan (called a protocol) that has been approved by an ethics committee.
Ethical approval
All trials need to be assessed by an independent Research Ethics Committee (REC) to ensure that participants are protected. An REC safeguards the rights, safety, dignity and wellbeing of the people participating in research. They review applications for trials and give an opinion about the proposed participant involvement and whether the research is ethical.
RECs are independent of research sponsors (that is, the organisations hosting the research) and investigators. This enables them to be completely unbiased in their judgment.
All researchers and their teams who will be carrying out the trials will have been trained to a high standard. They will have gone through regular training and/or accreditation so they know exactly what is needed and allowed to comply with the ethics approval.