GLOSSARY

A serious adverse event (SAE) is any adverse event or adverse reaction that results in death, is life-threatening*, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Medical judgement should be exercised in deciding whether an adverse event/reaction should be classified as serious in other situations. Important adverse events/reactions that are not immediately life-threatening or do not result in death or hospitalisation, but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definition above, should also be considered serious.

Life-threatening in the definition of a serious adverse event or serious adverse reaction refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.

Side effects are undesired effects that are related to a treatment. For example, if you are given a drug to treat an illness and it makes you sick (e.g. dizziness, stomach ache or a rash), this would be described as a side effect. Clinical trials will often look at short- and long-term side effects related to a treatment. Some side effects may be serious and need to be reported to regulatory authorities (usually the MHRA or FDA).

An individual, company, institution, or organisation that takes responsibility for the initiation, management, and/or financing of a clinical trial.

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.

Systematic reviews aim to bring together the results of all studies that have been carried out around the world addressing a particular research question. They provide a comprehensive and unbiased summary of the research.

For example, one clinical trial may not give a clear answer about the effectiveness of a treatment. This might be because the difference between the treatments being tested was very small, or because only a small number of people took part in the trial. So systematic reviews are used to bring the results of a number of similar trials together, to piece together and assess the quality of all of the evidence. Combining the results from a number of trials may give a clearer picture. When researchers combine the numerical results of these trials and compare them, this is called a meta-analysis.