Sunday, 22 May 2022, 11:07 PM
Site: EUPATI Open Classroom
Course: EUPATI Open Classroom (EUPATI Open Classroom)
Glossary: Glossary
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Microarray

DNA microarray analysis is a technique that scientists use to determine whether genes are switched on or off. If a gene is switched on, it is known as gene expression. Scientists use DNA microarrays to measure the expression levels of thousands of genes at the same time. The result is known as an expression profile. This technique is used in many areas of biological and medical research. It can give valuable information about, for example, what genetic changes are responsible for tumour growth in specific individuals, or whether the expression profile of an individual makes them suitable for a specific treatment.

Microgram

Microgram (Ојg) is a metric system unit of mass. A µg is equal to one millionth (1Г—10€’6) of a gram. Micrograms are typically used in a laboratory setting in early medicines development, or when measuring the concentration of a medicine in the blood.

Minimal Anticipated Biological Effect Level

The Minimal Anticipated Biological Effect Level (MABEL) is the anticipated dose needed to result in a biological effect in participants of a clinical trial. It is a safety window based on pharmacological threshold. The minimal anticipated biological effect level is recommended as a useful approach to calculate the Safe Starting Dose, as it is the lowest dose that is active.

Ministry of Health – Department of Pharmaceutical Services

Cypriot National Competent Authority. http://www.moh.gov.cy/"

Ministry of Health, Labour and Welfare

Japanese Health Ministry. http://www.mhlw.go.jp/"

Misconduct

Scientific misconduct is unethical behaviour or the failure to follow established guidelines (such as Good Clinical Practice) in scientific research.

Misconduct includes making things up, changing or lying about research, or copying the work of others (plagiarism). It also includes the failure to follow established guidelines where that failure is deliberate or dangerous “ researchers have a duty of care to participants in clinical trials and must take reasonable steps to protect their health and data privacy.

Scientists could be found guilty of misconduct in research if they conceal misconduct by others. The MRC's definition does not include honest error or honest differences in designing or carrying out research. Similarly, it does not include poor research unless there is 'intention to deceive'.

Molecular biomarker

A biological marker, or biomarker, is something that can be measured, which points to the presence of a disease, a physiological change, response to a treatment, or a psychological condition.

A molecular biomarker is a molecule that can be used in this way for example, glucose levels are used as a biomarker in managing diabetes. Non-molecular biomarkers include medical images (for example, MRI brain images can provide information about the progression of multiple sclerosis).

Biomarkers are used in many scientific fields. They are used in different ways at different stages of medicines development, including in some cases as a surrogate endpoint to indicate and measure the effect of medicines in trials. For example, haemoglobin levels have been used in Phase III trials to support development of therapies for Type 1 Gaucher disease. This is a rare disease that affects multiple organ systems and shortens life expectancy, but it can take years to show any clinical changes. Therefore clinical changes are not a good way to evaluate the impact of new treatments for this disease, and biomarkers that show earlier changes required.

Multi-Arm Multi-Stage

Multi-Arm Multi-Stage (MAMS) trials have a specific design that allows for several different treatments to be evaluated simultaneously against the standard treatment in a single trial.

Multiple Ascending Dose

Multiple Ascending Dose

Multiplicity

Multiplicity occurs in clinical trials when a single clinical trial has several objectives, such as:

  • assessing several different doses of a treatment,
  • using several different endpoints to measure different aspects of a disease, or
  • looking at several different subgroups of patients.

Multiplicity can affect statistical analyses and therefore undermine trial conclusions if it is not addressed.

Multiplicity can increase the Type I error rate. A number of statistical methods can be used to control the Type 1 error rate. The methods to be used in a clinical trial should be detailed in the study protocol or the statistical analysis plan for that trial.