How is a trial designed and managed? Clinical trials are designed by doctors and scientists and increasingly together with patients. It is very important that patients are involved as early as possible as they are the patient experts and can see the disease and any research in a different way to researchers. The first step is to decide which questions need answering, and then to look carefully at the results of any trials that have already been done and any other research evidence (a systematic review). Then doctors, nurses, patients and researchers work together to design the trial. This is written down in the trial protocol. All trial protocols in the UK have to be approved by a research ethics committee which checks that the trial is ethical. This means people are asked to take part in an appropriate way, with clear information to help them decide whether to take part, and they understand what it means to take part and issues of confidentiality. Clinical Trials can involve many partners. Here are some examples: Clinical research network (CLRN/CRN) The Clinical Research Network is made up of 15 Local Clinical Research Networks that cover the length and breadth of England. These local networks coordinate and support the delivery of research across the NHS. Higher Education Institution (HEI) A higher Education Institute is another name for a university or another institute that provides a higher education. Queen Mary University is an HEI. Researchers in an HEI support clinical trials in their specialist area of research. DMEC Data Monitoring and Evaluation Committee. This committee leads on all aspects of managing the amount of data that is generated during the trial and makes sure that there is enough of the right data to deliver an answer to the research question. If it is concerned about this aspect of the trial it needs to feed this back to a Trial Steering Committee and/or Trial Management Group. TMG Trial Management Group. The group of people who have day-to-day responsibility for running a trial. TSC Trial Steering Committee. The group of people (that includes the TMG) that supports the TMG to keep the trial on track and deal with any challenges that come up while its running. For example, any problems with data highlighted by the DMEC will be considered by the TSG.