Glossary

Coordination Group for Mutual Recognition and Decentralised procedures – human (CMDh) http://www.hma.eu/cmdh.html"

In the context of pharmacoeconomics, cost effectiveness is studied by looking at the results of different interventions by measuring a single outcome, usually in 'natural' units (for example, life-years gained, deaths avoided, heart attacks avoided, or cases detected).

Alternative interventions are then compared in terms of cost per (natural) unit of effectiveness in order to assess how it provides value for money. This economic evaluation helps decision-makers to determine where to allocate limited healthcare resources.

Cost effectiveness, however, is only one of a number of criteria that should be used to determine whether or not interventions are made available. Other issues, such as equity, needs, and priorities should also be part of the decision-making process.

Council for International Organisations of Medical Sciences (CIOMS) http://www.cioms.ch/"

Council of Health Ministers (CDSP) http://www.coe.int/t/dg3/health/CDSP_en.asp"

Compounds under investigation as potential new medicines must meet certain criteria, at each stage of development, in order to progress further. These criteria need to be agreed upon by the medicines developers. A ˜go™ decision means that the compound meets the criteria, and will be advanced to the next development step. Failure to meet the criteria will lead to a ˜no-go™ decision and the medicine development will stop.

A cross-sectional study is one type of observational study, in which the researcher does not perform any intervention (such as administering a medicine).

Cross-sectional studies are primarily used to find out how many cases of a disease are present in a population at a given point in time (called 'prevalence'). They are used to assess the health needs of a population and are useful in planning and allocating health resources. Cross-sectional studies are generally performed by survey/questionnaire or interview.

Danish National Competent Authority. http://laegemiddelstyrelsen.dk/en/"

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 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 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).