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T

Translated

In the field of genetics, translation is the process by which a protein is made from messenger RNA (mRNA). During translation, an RNA sequence is read and translated into the code of amino acids, which are the building blocks of proteins.

Treatment Emergent Adverse Event

Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.

In medicines development terminology, an adverse event (AE) is any undesirable event that occurs after a participant officially consents to take part in a trial (and could occur before treatment begins). An adverse event may or may not be associated with the medicine under investigation, but must be documented because it happened during the trial period.

A treatment emergent adverse event (TEAE) is an adverse event that occurs only once treatment has started.

Treatment group

In a clinical trial, the treatment group (as opposed to the control group) usually refers to the group of participants that receives the treatment under investigation. The treatment group is also known as the ˜treatment arm™.

Trial arm

A trial arm is a group of participants that receives the same interventions, or no intervention, according to the study protocol. Many randomised trials have two arms, but some may have three or even more. This is decided before the trial begins.

Trials with several arms (multi-arm) allow more than one treatment to be tested at once, and can reduce the costs and time needed during clinical development. Multi-arm, multi-stage (MAMS) trials take this idea a step further and allow the recruitment of participants in a particular arm to be stopped partway through if that treatment is not producing satisfactory results. MAMS can also allow for new treatments to be added to the trial as they become ready for testing.

Type I Error

Type I Error occurs in statistical hypothesis testing when a null hypothesis, which is actually true, is incorrectly rejected. Type I errors are also known as 'false positives' they are the detection of a positive effect where no effect actually exists.

As a stark example, Type I errors could kill a patient - for instance, if a study incorrectly found that the standard of care was not better than the new treatment, and consequently the new treatment was given to patients, the results may be catastrophic.

Type I errors cannot be completely avoided, but researchers should decide on an acceptable level of risk of Type I error when designing clinical trials. A number of statistical methods can be used to control the Type I error rate. The methods to be sued in a clinical trial should be detailed in the study protocol or the statistical analysis plan for that trial.

Type II Error

Type II Error occurs in statistical hypothesis testing when the null hypothesis is incorrectly accepted. Type II errors are also known as 'false negatives' they are the failure to detect a positive effect where the effect does exist.

Type II errors mean that potentially valuable research goes to waste. As no positive effect is detected, research may be halted. This research may have been useful, but as no further study takes place, no harm is done to patients.

Type II errors cannot be completely avoided, but researchers should decide on an acceptable level of risk of Type II error when designing clinical trials. To reduce the risk of Type II errors to acceptable levels, the power or sample size (the number of participants in a study) can be increased.

U

Unexpected Adverse Reaction

An unexpected adverse reaction is a harmful and unintended response to a medication which is not consistent with applicable product information or characteristics of the medicinal product.

Unique Device Identification

The Unique Device Identification (UDI) is a unique number, or combination of numbers and letters, given to a medical device. It is in two parts: one part identifies the device the other part identifies the producer. The aim of the UDI system is to improve patient safety: it means devices can be traced and recalled more easily, and it makes counterfeiting (production of fake copies) more difficult. The UDI is given to medical devices in addition to other labelling requirements.

United Kingdom Ethics Committee Authority


Universal Declaration of Human Rights

The Universal Declaration of Human Rights is an international document that states the basic rights and fundamental freedoms to which all human beings are entitled. It was adopted by the General Assembly of the United Nations in 1948, as a result of the experience and atrocities of the Second World War. It represented the first global expression of rights to which all human beings are entitled “ regardless of nationality, place of residence, gender, national or ethnic origin, colour, religion, language, or any other status.

The Declaration consists of 30 articles, and a number of key principles including:

  • Universality
  • Interdependence and indivisibility
  • Equality and non-discrimination

The declaration has been translated into law in various forms and has inspired more than 80 international human rights treaties and declarations, which together constitute a comprehensive, legally binding system for the promotion and protection of human rights.

The full text of the Declaration is published by the United Nations on its website.


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