Dementia Support Line
About clinical trials for dementia
Clinical trials are the main way that researchers can identify whether a new approach, such as a new drug or a device, is safe and effective in people.
What are the phases of a clinical trial?
Clinical trials can take a few months to a few years, and this depends on the question being investigated, the design of the study and the phase of research.
Challenging common myths about research trials
There are many common misconceptions about participating in clinical research. Taking part is often much easier and safer than people think.
How are risks reduced in clinical trials?
Clinical trials in the UK are carefully regulated to protect participants and make sure that there are high standards of safety and ethics for every research study.
This is done by various regulatory bodies and authorities:
The Health Research Authority (HRA) reviews and approves research proposals to protect participants and uphold ethical standards.\
They make sure that research teams comply with regulations, rules and laws to ensure that research integrity is maintained.
- The Medicines and Healthcare products Regulatory Agency (MHRA) approves, monitors and inspects trials to make sure they comply with safety regulations.
All new clinical trials undergo a combined review by both HRA and MHRA. This makes sure the processes are thoroughly inspected and protects both research integrity and research participants.
Research teams must also follow the principles and guidelines of Good Clinical Practice (GCP) when conducting clinical trials. These are internationally recognised standards for ethical and scientific quality. GCP ensures that participant rights, safety and wellbeing are protected, and any data collected is accurate and trustworthy.
Consent in clinical trials
Before participating in research, research teams will ask for informed consent. This involved participants receiving detailed information about what the study involves, the potential risks, benefits and outcomes.
Potential research participants must be provided with all the relevant information about what a study will involve. They'll be given sufficient time to consider this and will have the opportunity to have any questions answered.
If the person then decides to take part, they will be asked to sign a consent form which is a legal document and details exactly what they are agreeing to before any study procedures begin. The informed consent process will always be carried out by a suitably qualified and trained member of the study team.
Be part of dementia research
Do you want to change the future for people affected by dementia?
Dementia studies offer hope that one day we will be able to end the devastation of dementia.
The goal of a Phase 1 trial is to test safety of a new treatment or device.
Participants are usually split into small groups (often between 3-6 people). Researchers start at the smallest dose and only when that is shown to be safe in the first group of participants do they move to the next dose level.
Each group then receives a higher dose than the previous one until researchers identify the ‘maximum tolerated dose’, which is the highest dose that can be given without worry or troublesome side effects.
Phase 1 trials can be split further into two phases:
Once the correct dose level has been found, the study treatment will move into a Phase 2 trial. However, not all treatments will progress beyond Phase 1.
Phase 2 clinical trials test whether new treatments or devices work, and whether they continue to be safe.
Typically, Phase 2 trials need around 100-300 participants. If the results of a Phase 2 are promising, then the new treatment or device will move to Phase 3.
Phase 3 trials are designed to compare the new treatment or device with existing therapies or a ‘placebo’ (an inactive treatment or an inactive device). This can sometimes be referred to as a ‘sugar’ pill or ‘dummy’ pill. Placebos are designed to look identical to the real treatment but have no therapeutic effect
Usually, these trials are designed as randomised and ‘double-blind’ (where neither the participants nor researchers know who is receiving the active study treatment).
Phase 3 trials build on safety and effectiveness results from Phase 1 and Phase 2 trials. They help researchers to better understand the overall risks and benefits of the study treatment or device, as well as the impact they could have on a participant’s quality of life.
Phase 3 trials can involve hundreds to thousands of patients and can take many years to complete.
Successful Phase 3 results can lead to drug or device approvals with regulatory bodies. In the UK, this is done by the Medicines and Healthcare products Regulatory Agency (MHRA).
The goal of Phase 4 trials is to track the long-term safety and effectiveness after the treatment is approved and in use by people in real-world settings.