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Danish Medicines Agency (Denmark)

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) is an independent group of experts set up to protect patient safety during a clinical trial. This board periodically reviews clinical study data (and they have access to unblinded data in case of blinded studies), incidental event reporting, and clinical study performance. The DSMB provides independent advice to ensure participants are not exposed to undue risks, and make recommendations concerning the continuation, modification, or termination of a trial.

Data exclusivity

Data exclusivity refers to the period during which the data of the original marketing authorisation holder is protected. It is the time during which another company cannot use the originator™s data in support of another marketing authorisation application, i.e.: generics, hybrids, biosimilars. Therefore, competent authorities may not accept such an application during this period of time. In Europe, this protection period lasts for a minimum of eight years and is intended to incentivise innovation.

Data Manipulation

Data manipulation is the process of taking data and manipulating (reformatting) it to be easier to read or better organised. For example, a list of data entries could be organised in alphabetical order, making it easier to view and find information.

However, these practices should be used carefully as they can lead to the selective incorrect reporting of data or creation of false results (see bias).

Data Merging

Data merging is a process that involves combining data from different sources, and providing users with a single view of these data.

For example:
  • data from different hospital sites within a clinical trial will be combined for analysis
  • data generated from entirely separate scientific studies might be combined if this will provide a better data set for analysis

Data Mining

Data mining is the practice of searching through existing large sets of data to find useful patterns or trends. Data mining can generate new hypotheses or new ideas for diagnosing, preventing, or treating diseases. It can, for example, lead to predictions for individual responses to medicines, or help with the design of completely new medicines.

The pharmaceutical industry uses sophisticated computer-driven data-mining techniques in an effort to extract information from the large amounts of chemical, biological, and clinical data available.

Data can be mined from clinical trial data sets, data from biobanks, or any other data set that is accessible “ for example, data sets held by public research organisations or insurance companies.

Data Monitoring Committee

Data Monitoring Committee

Dear Doctor letter

Dear Doctor letters are correspondence • often in the form of a mass mailing from the marketing authorisation holder of a human medicine or biologic • intended to alert doctors and other healthcare providers about important new or updated information regarding a marketed medicine or biologic.

Such information about medicinal products may emerge throughout a product™s life cycle.

Decentralised procedure

The decentralised procedure is a process for authorising medicines in more than one European Union member state at the same time.


Chemical products formed from the breakdown of a medicine due to for example light, temperature, water, reaction with non-active substances, or container and closure systems, etc.

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