title: Pharmacoepidemiology studies: what levels of evidence and how can they be reached?
abstract: In pharmacoepidemiology studies, the nature of the research question will dictate the choice of methodological approach and the conditions for optimizing the level of evidence. Thus, to document the treated population and the modes of use of a new drug in real-life prescribing conditions, a descriptive approach through cross-sectional or longitudinal studies conducted on databases, or else ad-hoc studies, will be preferred. On the other hand, evaluation of the real-life "effectiveness" of a new drug will be based on cohort, case-control or scientific modeling, depending on the drug and the disease of interest. For questions involving drug risks and safety, it is the adverse effects profile that will guide the choice of study design, both for identification of the effect (signal) and assessment of causation. In all cases, in the post-marketing authorization (MA) setting, the evidence acquired in pre-MA studies serves as the basis for generating hypotheses. Whatever the research question and the method chosen to address it, the potential biases and their impact on the results need to be identified. In certain cases, a combination of several complementary approaches may prove preferable to a single study.
authors: Service de Pharmacologie médicale et clinique, Université de Toulouse, INSERM 1027, Toulouse, France.
authors: Maryse
authors: M
authors: Lapeyre-Mestre
authors: Claudine
authors: C
authors: Sapède
authors: Nicholas
authors: N
authors: Moore
authors: Pascal
authors: P
authors: Bilbault
authors: Patrick
authors: P
authors: Blin
authors: Damien
authors: D
authors: Chopy
authors: David
authors: D
authors: Evans
authors: François
authors: F
authors: Gueyffier
authors: Laure
authors: L
authors: Lacoin
authors: Muriel
authors: M
authors: Malbezin
authors: Joëlle
authors: J
authors: Micallef
authors: Dana
authors: D
authors: Morlet-Vigier
authors: Sophie
authors: S
authors: Muller
authors: Emmanuel
authors: E
authors: Oger
authors: Yannick
authors: Y
authors: Plétan
authors: Gérard
authors: G
authors: Pons
authors: Patrice
authors: P
authors: Verpillat
authors: Caroline
authors: C
authors: Vigneau
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D015340:Epidemiologic Research Design; D055317:Evidence-Based Practice / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D061214:Patient Safety / Q000706:statistics & numerical data; D017891:Pharmacoepidemiology / Q000379:methods* / Q000706:statistics & numerical data; D016896:Treatment Outcome