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Standard Operating Procedure

Standard Operating Procedure

Standardised Mortality Ratio

Standardised Mortality Ratio

Statistical analysis plan

A statistical analysis plan (SAP) describes the planned analysis for a clinical trial. It contains the necessary details so that is can be followed and reproduced, providing clear and complete templates for each analysis.

Statistical Inference

Statistical inference is the process of drawing conclusions about a population through statistical analysis from a sample of that population.

For example: In clinical trials, hypothesis testing is a means of drawing conclusions on the effect of the medicines under study on the population that the sample of trial participants was drawn from. For instance, the null hypothesis would state that the medicine being studied does not affect symptom reduction while the alternate hypothesis would state the opposite. Statistical inference from the trial data will allow researchers to reject the null hypothesis if the analysis indicates a statistically significant effect.

Statistical Significance

Statistical significance is a fundamental aspect of hypothesis testing. In any experiment using a sample from a population (for instance, a sample of patients with a particular disease) there is the possibility that an observed effect may be due to differences between the sample and the whole population (sampling error) rather than the medicine under study. A test result is called statistically significant if it has been predicted as unlikely to have occurred by sampling error alone, according to a threshold probability: the significance level.

Statistical significance does not imply importance or practical significance. For example, the term clinical significance refers to the practical importance of a treatment effect. Researchers focusing solely on whether their results are statistically significant might report findings that are not relevant in practice. It is always prudent to report an effect size along with p-values. An effect size measure quantifies the strength of an effect, and makes it easier to draw conclusions on the practical implications.

Statistics

Statistics are a mathematical methods of describing and drawing conclusions from data. Statistics are an essential part of the medicines development process at multiple stages.

Státní ústav pro kontrolu léčiv


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Štátny ústav pre kontrolu liečiv


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Stem Cell Therapy

Stem cell therapy, also known as regenerative medicine, is the use of stem cells to treat or prevent a disease or condition. Stem cells grown in a lab are manipulated to specialise into specific types of cells, such as heart muscle cells, blood cells or nerve cells. The specialised cells can then be implanted into a person. For example, if the person has heart disease, the cells could be injected into the damaged heart muscle. The healthy transplanted heart cells could then contribute to repairing defective heart muscle.

Stem Cells

Stem cells are undifferentiated (unspecialised) cells that can transform into specialised cells and can divide to produce more stem cells. They have the potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as an internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. There are two types of stem cells: Embryonic stem cells, found in the early stage of embryonic development, can differentiate into all the specialised cells of the body, such as muscle cells, red blood cells, and nerve cells. Adult stem cells, which are found in some adult tissues, can act as a repair system for the body.


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