GLOSSARY

A Case Report Form (CRF) is a printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each subject in a clinical trial. The KCTU uses an online database that utilises electronic CRFs (eCRFs) so that data can be entered directly at each study site. These eCRFs are designed according to a guidance document created by the KCTU in accordance with regulatory guidelines and trial-specific changes are implemented during the development phase.

The Cell Therapy Unit (CTU) within KHP is the largest manufacturing facility of its kind currently built in Europe, with capacity to produce more than six final products simultaneously and a total of around one thousand therapies per year. This is a complex and sophisticated Good Manufacturing Practice (GMP) Unit built to the exacting standards required to meet the licensing requirements of the Medicines and Healthcare products Regulatory Agency (MHRA) for the manufacture of human cell and gene based therapies.

A Clinical Data Management System (CDMS) is a tool used to manage data in clinical research. The KCTU utilise an electronic data capture (EDC) system so that the data is stored and managed in an electronic form (MACRO).

The NIHR GSTT Clinical Research Facility (CRF) has research areas on the Guy’s Campus, the St Thomas’ Campus and at the Evelina Children’s Hospital.

The NIHR / Wellcome Trust King’s Clinical Research Facility (CRF) opened in November 2012. The build comprises of two main research areas within King’s College Hospital’s Cheyne Wing, spanning three floors with a further standalone unit. Each area has been designed and built to compliment the other in terms of ability to offer a unique and neutral space to carry out trials in a dedicated research setting.

Clinical trials are research studies involving participants, that compare a new or different type of treatment with the best treatment currently available. They test whether the new or different treatment is safe and effective by comparing it to what already exists. No matter how promising a new treatment may appear during tests in a laboratory, it must go through clinical trials before its benefits and risks can really be known. This also applies to many different forms of treatment, such as surgery, radiotherapy, physical and behavioural interventions, not just drugs. If there is no standard treatment, the new treatment is usually compared with no treatment or with a ‘dummy’ treatment (or placebo).

Clinical trials units (CTU) are specialised biomedical research units that can design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials, cluster randomised trials, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial. Some CTU’s are accredited by the UKCRC. The only such unit across KHP is the KCTU.

The Consolidated Standards of Reporting Trials (CONSORT) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomised controlled trials. The CONSORT Statement is an evidence-based minimum set of recommendations for reporting randomised trials. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. The CONSORT Statement consists of a checklist and a flow diagram: the checklist items focus on reporting how the trial was designed, analysed, and interpreted; the flow diagram displays the progress of all participants through the trial.

If you take part in a crossover trial, your treatment will change partway through the trial. For example, if a trial is comparing the effectiveness of 2 different sorts of exercise, you might take part in exercise A for the first part of the trial and then exercise B for the second, then perhaps back to A again – and so on. You cross over from one treatment group to the other, and comparisons are then made between how well you felt during the different periods. Often there will be several cross-overs in a crossover trial.