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Lääkealan turvallisuus- ja kehittämiskeskus
Finnish Pharmaceuticals Pricing Board, subordinated to the Ministry of Social Affairs and Health, Insurance Department. http://www.hila.fi/"
Lead-time bias is a bias resulting from taking starting measurements at different times. This can cause, for example, survival times for patients to look like they are getting better when they are not.
For example, cancer is often diagnosed when a patient develops symptoms, and the patient's survival time is generally defined as how long they live after diagnosis. If a screening test can lead to cancer diagnosis earlier, before symptoms develop, this creates a longer period of survival simply because diagnosis was earlier. The patient may not actually survive to a later date than they would have done without the screening.
Legally Authorised Representative
A legally authorised representative (LAR) is an individual authorised (for example by a court) to make decisions on behalf of another person. In circumstances where a patient is unable to give informed consent themselves (for instance, patients in critical care units), sometimes a legally authorised representative can give consent or permission on their behalf, including about medical treatments.
Life Years Gained
Life years (LY) gained is a measure in health economics. It expresses the additional number of years of life that a person lives as a result of receiving a treatment.
Lifetime prevalence is the proportion of a population that, at some point in their life, has experienced a particular health event, risk factor or disease. For example, in a survey, you might be asked if you have ever smoked. Lifetime prevalence is calculated by comparing the number of people found to have experienced the health event with the total number of people studied.
Live-attenuated vaccines use a weakened (attenuated) form of the microbe that causes a disease.
A statistical test to compare the survival distributions of two (or more) groups.
This test is used when one wants to test the null hypothesis: that there is no difference in the probability of an event (e.g. death) between the two groups at any time point. The analysis is based on the times of events (or deaths), and it is most likely to detect a difference between the groups compared when the risk of an event is greater for one group.
Low-intervention clinical trial
A low-intervention clinical trial studies an authorised medicine. Its use according to the trial protocol follows the terms of the marketing authorisation, or published scientific evidence on safety and efficacy. Any additional procedures must not pose more than minimal additional risk or burden to the safety of the participants compared to normal local clinical practice. Low-intervention clinical trials are used for example to investigate safety and efficacy questions that have arisen since authorisation.
Refer to Regulation 2014/536 for more information.