Pharmacoepidemiology studies: what levels of evidence and how can they be reached?

Maryse Lapeyre-Mestre; Claudine Sapède; Nicholas Moore; Pascal Bilbault; Patrick Blin; Damien Chopy; David Evans; François Gueyffier; Laure Lacoin; Muriel Malbezin; Joëlle Micallef; Dana Morlet-Vigier; Sophie Muller; Emmanuel Oger; Yannick Plétan; Gérard Pons; Patrice Verpillat; Caroline Vigneau

doi:10.2515/therapie/2013038

Journal articles

Pharmacoepidemiology studies: what levels of evidence and how can they be reached?

Maryse Lapeyre-Mestre ^{1, 2} Claudine Sapède ³ Nicholas Moore ^{4, 5} Pascal Bilbault ⁶ Patrick Blin ⁷ Damien Chopy ⁸ David Evans ⁹ François Gueyffier ¹⁰ Laure Lacoin ¹¹ Muriel Malbezin ¹² Joëlle Micallef ¹³ Dana Morlet-Vigier ¹⁴ Sophie Muller ¹⁵ Emmanuel Oger ^{16, 17} Yannick Plétan ³ Gérard Pons ¹⁸ Patrice Verpillat ¹⁹ Caroline Vigneau ²⁰

1 LEASP - Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps

2 Laboratoire de pharmacologie médicale et clinique

3 Laboratoire Roche [Boulogne-Billancourt]

4 Department of Pharmacology

5 Laboratoire de Pharmacologie Expérimentale

6 Hôpital de Strasbourg

7 Département Hospitalo-Universitaire de Pharmacologie de Bordeaux

8 Neuro-Immunologie Virale

9 Laboratoire pharmaceutique Lilly France [Neuilly-sur-Seine]

10 Evaluation et modélisation des effets thérapeutiques

Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]

11 HAS - Haute Autorité de Santé [Saint-Denis La Plaine]

12 Janssen-Cilag [Issy-les-Moulineaux]

13 EuroMov - Euromov

14 IMS Health [Puteaux]

15 Laboratoire GlaxoSmithKline [ Marly-le-Roi]

16 CIC-IT Rennes

17 Service de Pharmacologie

18 U1129 - Epilepsies de l'Enfant et Plasticité Cérébrale

19 Neurologie et thérapeutique expérimentale

20 IGDR - Institut de Génétique et Développement de Rennes

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.

Document type :

Journal articles

Domain :

Life Sciences [q-bio]

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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01120370
Contributor : Laurent Jonchère <>
Submitted on : Wednesday, February 25, 2015 - 2:17:22 PM
Last modification on : Thursday, January 14, 2021 - 11:29:21 AM

Pharmacoepidemiology studies: what levels of evidence and how can they be reached?

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