[Pharmaco-epidemiology: identification of needs, databases, and study quality criteria].
Reference data on pathologies, their management, risk factors and the use of drugs in real life is necessary. In France, there are no existing databases of a set of systematically recorded data which associate information on drugs and morbidity/mortality. In contrast, there are a great number of studies focused on pathologies, their management or on drugs. A directory that could identify these databases and a means of accessing them would be desirable. Pharmaco-epidemiology studies must answer epidemiologically specific quality criteria, which must be planned at study conception. The protocol must be developed with a scientific committee on which there are epidemiologically experienced people. It is a prerequisite that a committee of experts with epidemiological competence should give advice on the 'acceptability' of the protocol, that is on the aim and the methodology. Data collection must be the subject of specific quality control of both the study and its aims. Cross-checking with other sources of data is recommended when possible. The coordinator of each study must send a final report to investigators and publish the results.
Vray
M
M
Hôpital Paul Brousse, Service des Maladies Infectieuses, 14 avenue Paul Vaillant Couturier, 94804 Villejuif, France.
Szafir
D
D
Jaillon
P
P
D002985:Clinical Protocols / Q000592:standards; D016208:Databases, Factual; D004341:Drug Evaluation / Q000379:methods / Q000592:standards; D004812:Epidemiologic Methods; D004813:Epidemiology; D005602:France; D006301:Health Services Needs and Demand; D006801:Humans; D009042:Motivation; D010600:Pharmacology; D011785:Quality Assurance, Health Care / Q000379:methods; D011786:Quality Control; D012107:Research Design / Q000592:standards*; D012108:Research Personnel / Q000523:psychology