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D1.2 Core Evidence Elements for Generating Medication Safety Evidence for Pregnancy Using Population-Based Data Core Data Elements, Design and Analytical Foundations

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D1.2 Core Evidence Elements for Generating Medication Safety Evidence for Pregnancy Using Population-Based Data Core Data Elements, Design and Analytical Foundations IMI2 821520 - ConcePTION ConcePTION WP1 – Moving beyond pregnancy registries to enhance our understanding of disease-related pregnancy outcomes, medication use and safety of use during pregnancy D1.2 Core evidence elements for generating medication safety evidence for pregnancy using population-based data Core data elements, design and analytical foundations Lead contributor Christine Damase-Michel (21 - University hospital of Toulouse) Keele Wurst (41 - Glaxo Smith Kline Research and Development LTD (GSK) LTD) Other contributors Anna Belle Beau, Justine Bénévent, Caroline Hurault-Delarue (21 - University hospital of Toulouse, FR) Rebecca Bromley (28 - University of Manchester, UK) Helen Dolk, Maria Loane, Joanne Given (2 - Ulster University, UK) Anja Geldhof (37 - Janssen Pharmaceutica NV, BE) Sue Jordan (23 - Swansea University, UK) Hu Li (42 - Eli Lilly and Company Limited, USA) Michael Stellfeld, Ditte Mølgaard- Nielsen (46 - Novo Nordisk A/S, DK) Joan Morris, Matt Pryce (15 - St George's Hospital Medical School, UK) Hedvig Nordeng (14 - University of Oslo, NOR) Meritxell Sabidó (45- Merck Healthcare KGaA, DE) Jennifer Zeitlin (19 - INSERM, FR) 1 Document History Version Date Description V0.1 19/09/2019 First draft V0.2 04/12/2019 Expert authors contributions V0.3 10/02/2020 Revised according to WP1 partners comments V0.4 19/03/2020 Revised according to WP1 partners comments V0.5 14/04/2020 Revised according to WP1 partners comments V0.6 07/05/2020 Expert authors contributions V1.0 09/09/2020 Final version for stakeholder consultation meeting V1.1 13/01/2021 Revised according to the stakeholder consultation meeting V2.0 29/01/2021 Final version for MB 2 Table of contents Document History .................................................................................................................................. 2 List of Tables .......................................................................................................................................... 5 List of Figures ........................................................................................................................................ 5 Table of Annexes.................................................................................................................................... 5 Abbreviations ......................................................................................................................................... 6 Authors ................................................................................................................................................... 8 External experts consulted ...................................................................................................................... 9 Acknowledgements ................................................................................................................................ 9 Abstract ................................................................................................................................................ 10 1. Introduction .................................................................................................................................. 11 2. Purpose ......................................................................................................................................... 12 3. Methods ........................................................................................................................................ 13 3.1. Publicly available reference and regulatory guidance documents ........................................ 13 3.2. Additional searches .............................................................................................................. 13 3.2.1. General literature search ............................................................................................... 13 3.2.2. Studies registered in the EU PAS Register ................................................................... 14 3.2.3. Studies referred to in product labels of prescribed medications, currently approved by European Medicines Agency (EMA) ........................................................................................... 14 3.3. Redaction and review ........................................................................................................... 14 4. Core evidence elements ................................................................................................................ 16 4.1. Core outcome data elements ................................................................................................. 16 4.1.1. Gestational age ............................................................................................................. 17 4.1.2. Pregnancy outcomes ..................................................................................................... 17 4.1.3. Maternal outcomes ....................................................................................................... 33 4.2. Ascertainment of medication exposure and aetiological window ........................................ 35 4.2.1. Medication exposure .................................................................................................... 35 4.2.2. Aetiological window .................................................................................................... 37 4.2.3. Exposure time window ................................................................................................. 39 4.3. Design considerations ........................................................................................................... 39 4.3.1. Population data sources in Europe ............................................................................... 40 4.3.2. Study objectives ........................................................................................................... 42 4.3.3. Main study designs suitable to population data ............................................................ 42 4.3.4. Choice of comparison groups ....................................................................................... 44 4.3.5. Covariates: confounders, mediators, moderators ......................................................... 45 3 4.3.6. Controlling for confounding by indication and/or severity .......................................... 49 4.4. Analytical methods ............................................................................................................... 49 4.4.1. Exploratory analyses .................................................................................................... 49 4.4.2. Choice of the statistical model ..................................................................................... 50 4.4.3. Competing risk ............................................................................................................. 51 4.4.4. Controlling for measured confounders ......................................................................... 51 4.4.5. Statistical power and sample size considerations ......................................................... 53 5. Default list of core evidence elements .......................................................................................... 55 6. Quality .......................................................................................................................................... 57 6.1. Research quality criteria checklists ...................................................................................... 57 6.2. Limitations in pregnancy safety studies ............................................................................... 60 6.2.1. Study size ..................................................................................................................... 60 6.2.2. Missing data ................................................................................................................. 60 6.2.3. Information bias............................................................................................................ 61 6.2.4. Selection bias ................................................................................................................ 63 6.3. Methods for validating data quality ...................................................................................... 64 6.3.1. Quality of a data source ................................................................................................ 64 6.3.2. Quality of methods and evidence ................................................................................. 65 7. Conclusion .................................................................................................................................... 67 8. References .................................................................................................................................... 68 9. Annexes ........................................................................................................................................ 79 4 List of Tables Table 1. Default minimal set of core evidence data elements for pregnancy safety studies Table 2. Available guidance that can be used for pregnancy safety studies List of Figures Figure 1. ConcePTION work packages Figure 2. Illustration of a confounder Figure 3. Illustration of a mediator Table of Annexes Annex 1: Literature search strategies for the systematic review of some therapeutic areas covered by the Demonstration Projects Annex
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