UKCRN provides support to facilitate clinical trials and other well designed studies.
What is a clinical trial?
A clinical trial is a research study in human volunteers which is designed to answer specific health questions, for example, to find out ways to treat, screen, diagnose or prevent disease.
Data collected during the study can provide information on whether a new treatment or procedure is safe, what the side effects are, and whether it is better than the current standard. Clinical trials are conducted in phases. The trials carried out at each phase have a different purpose and help answer different questions.
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dose range, and identify side effects.
In Phase II trials the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (hundreds or thousands) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. A Phase III trial can provide enough information for a new treatment or procedure to be used as the new ‘standard treatment’.
Phase IV trials, often referred to as post-marketing studies as they occur once a drug has been licensed for use, provide further information on side effects, safety and longer term risks and benefits.
Clinical trials are the most reliable and best way of testing a new treatment or of seeing whether one treatment works better than another and are needed to improve treatment and care for patients now and in the future.