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U

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.

Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych


Utility

Utility, or usefulness, is the (perceived) ability of something to satisfy needs or wants. In health economics, utilities measure the strength of patient preferences. For example, how important various factors are to patients, such as symptoms, pain, and psychological health. The impact of new treatments on those factors, and therefore on quality of life (QoL), can then be calculated. This is a common approach used by health technology assessment (HTA) bodies, which advise on whether treatments should be funded by (for example) government health departments.

V

Vaccine

Vaccines are biological preparations developed from modified versions of the micro-organisms that cause a disease. Vaccines improve or convey immunity to particular diseases, usually in an effort to prevent or cure disease.

Validity

Scientific validity refers to how well a measurement, test or study measures what it is intended to measure.

Valstybinė vaistų kontrolės tarnyba


Vector

In gene therapy, a vector is a method of delivering DNA into patients' cells. A common vector used in gene therapy is the adenovirus. A gene therapy vector must be customised to attempt treatment of a particular disorder. To be successful, a vector must target the right cells, the gene it is carrying must be activated in the patient, and it must avoid harmful side effects.

Vulnerable participants or populations

Vulnerable participants or populations are individuals or groups of individuals who are unable to give informed consent to take part in a clinical trial, such as children or people affected by mental health conditions, or who may come under pressure from others to take part. It also includes people whose willingness to volunteer in a clinical trial may be unduly influenced by their expectations of taking part.

If a trial is to include people from vulnerable populations, special attention should be paid to protecting their well-being, both by the investigators and the ethics committee that reviews the trial protocol.

W

Wash out period

In a clinical trial, this refers to a break in ongoing treatment. It is quite often used in crossover trials where a set period is defined before switching to a new medicine. In this period the levels of the previous medicine in the body and the effects should be reduced to zero.

Whole Genome Sequencing

Whole genome sequencing (WGS) is a laboratory process that determines the complete DNA sequence of an organism's genome at a single time. Great progress in the speed at which genomes can be sequenced, in the number of genomes that can be sequenced at the same time, and in the reducing the cost of sequencing has had a huge impact on medical research and medicines development.

High-throughput genome sequencing technologies have largely been used as a research tool and are currently being introduced into clinical practice. In the future of personalised medicine, whole genome sequencing will be an important tool to guide treatments.


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