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The removal of personal information (such as names or addresses of clinical trial participants) so that people using trial data cannot identify the individuals who took part. Truly anonymised data contain no information that could reasonably be used, by anyone, to identify individuals - even by cross-checking the data against other sources of information. Anonymous data are data that have had personal information removed.
Anonymous data has had all personal information (such as names or addresses of clinical trial participants) removed, so that people using trial data cannot identify the individuals who took part. Truly anonymised data contain no information that could reasonably be used, by anyone, to identify individuals “ even by cross-checking the data against other sources of information. Anonymous data are data that have had personal information removed.
Anonymous coding systems
Sets of data from individuals in a trial are given unique codes so they can be stored and managed properly. Anonymous coding systems (ACS) use codes that do not relate to personal information that might be used to identify the individual in any way (for example, a participant's initials or health record number must not be included in the code). This allows individuals taking part in clinical trials to remain anonymous.
Coding can be important to allow tracing of individuals in the future (for example to allow authorised health professionals to follow up on results that come out of trials). To enable this, information about which individual was given which code is usually held securely, for example at a separate location not involved in the trial.
The scientific study of the social, cultural and physical development of humans, past and present.
The part of a pathogen that stimulates a response from the immune system.
Area Under the Curve
In the field of pharmacokinetics, the Area Under the Curve (AUC) has a specific meaning. It is the region under a plotted line in a graph of medicine concentration in blood plasma over time. Typically, the area is calculated starting from the time the medicine is administered until the time when the concentration in plasma is insignificant. The area under the curve represents the total exposure that the body receives to an active substance, and helps to evaluate and compare bioavailability profiles between medicines. The time at which the highest concentration of the active substance is found in the blood is called Tmax, and the maximum concentration of the active substance found in the blood stream is called Cmax.
In clinical research this refers to any of the treatment groups in a randomised trial. Many randomised trials have two arms™ or groups, but some may have three or even more.
Attrition is the loss of participants during a clinical trial it is also known as the 'drop-out rate'. The opposite of attrition is 'retention'.
Attrition can cause bias in study results if more participants drop out of one study arm than another, or if there is a difference between the participants who drop out and those who continue. Attrition can affect how applicable the results of a study are (external validity), or the statistical power of a study.
Research suggests that using a combination of strategies can improve the retention of participants in trials. Many different methods may be appropriate, for example providing incentives for taking part, giving personal reminders of appointments, and involving patients and/or their carers throughout the trial-design process.