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Clinical trials are research studies that evaluate new treatments to determine their safety and effectiveness in humans. These studies rely on voluntary participation, which helps answer important…
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A patient information sheet is a document given to you before you decide whether to join a clinical trial. It explains the trial's purpose, the treatments being tested, potential benefits and risks…
Voluntary participation means your decision to join a clinical trial must be made freely, individually, and without pressure that could push you to accept risks you would not otherwise accept. This…
The sponsor — the entity responsible for organising, running and financing the trial — covers the cost of the investigational product itself. The sponsor also pays for the medical care that the trial…
Confidential patient data is health information that is linked to an identifier such as your name, address, or a national health service number. It includes your medical history, test results, and…
A phase 1 trial is usually the first study of a new medicine in people. Its main aims are to find out how much of the drug is safe to give, what side effects occur, and what happens to the drug in…
A Phase 1 trial is typically the first study of a medicine in humans, often called a "first-in-human" trial. Before it starts, the medicine has already been tested extensively in laboratory and…
A phase II clinical trial is a study conducted in patients who have the disease or condition a medicine is intended to treat. It is designed to explore whether the treatment works. It continues…
A biomarker is a defined and measurable characteristic used as an indicator of normal biological processes, disease processes, or a response to a therapeutic intervention. This definition is…
A Phase 3 study is designed to show whether a medical product gives a real treatment benefit to a specific group of patients, and it is sometimes called a pivotal study. It typically enrols 300 to…
A Phase III trial is a large, late-stage study designed to confirm whether an investigational treatment works. It also compares the treatment against a standard treatment or placebo in the population…
A Phase IV clinical trial is a study of a medicine that takes place after it has already received regulatory approval and is available to patients, and it is also called a post-marketing surveillance…
A placebo is an inactive substance or sham procedure – a sugar pill, a saline injection, or a mock surgical intervention – that has no direct pharmacological action on the condition under study. Some…
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