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Clinical trial authorisation
Before a clinical trial can start, the sponsor must apply for and be given clinical trial authorisation (CTA). Each European country has its own regulatory authority that assesses applications for clinical trial authorisations. For clinical trials that will take place in more than one European country, there is a Voluntary Harmonisation Procedure™ which allows one application to be submitted to the authorities in all the relevant countries.
As well as clinical trial authorisation, a positive opinion from an ethics committee (or institutional review board) is needed before a clinical trial can go ahead.
ClinicalTrials.gov is an online resource that provides information about clinical studies on a wide range of diseases. It includes information on whether the studies are recruiting patients, and a summary of the results of studies once they have finished.
The resource can be found at https://clinicaltrials.gov (address correct November, 2015).
Studies can be searched for by disease or by country. Although it is funded by the US government, it includes studies based around the world. The resource is aimed at patients and their families, healthcare professionals, researchers and the public. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).
A type of outcome assessment determined by a trained health-care professional after observation of a patient™s health condition.
Cohort studies are used to study how common diseases are, their causes, and their prognoses. Cohorts are groups of people who are selected on the basis of certain characteristics. For example, if exposure to a risk factor such as cigarette smoke is suspected to cause a disease, a cohort can be selected in which one group has been exposed and another group has not. Both groups are then studied for signs or symptoms of disease.
Cohort studies can be prospective (cohorts are identified before any signs of disease and are followed up over time) or retrospective (data is used that has already been collected, possibly over a long period of time).
Cohort studies are a kind of observational study, in which the researcher does not perform any intervention (such as administering a medicine).
Cohort studies are useful when it would be unethical to carry out a randomised controlled trial (RCT). For example, deliberately exposing people to cigarette smoke or asbestos would be unethical and therefore cannot be done.
An uninterrupted series of production, storage, and distribution activities, along with associated equipment and logistics, which maintain a desired low temperature range. It is necessary to maintain the quality and efficacy of certain medicines and vaccines.
College ter Beoordeling van Geneesmiddelen
Combined advanced-therapy medicines
Combined advanced-therapy medicines are medical products based on the combination of genes (gene therapy), cell therapy (cell therapy) or tissues (tissue engineering) with one or more medical devices as an integral part of the medicine.
Commissie Tegemoetkoming Geneesmiddelen
Commission de Remboursement des Médicaments
Belgian commission for reimbursement of medicines. http://www.inami.fgov.be/fr/inami/organes/Pages/commission-remboursement-m%C3%A9dicaments.aspx#.V16FmNKLRD8"
Commission évaluation économique et de santé publique