Table 1.
Studies funded by European Medicines Agency (EMA) to support the benefit‐risk evaluation of medicinal products (2010‐2017)a
| Study Title | EUPAS Register Numberb | Number of Databases | Number of Countries | Link to Publication of Results |
|---|---|---|---|---|
| A/H1N1 pandemic vaccines and pregnancy outcomes | 1705 | 1 | 1 | Link to study report included in EU PAS Register |
| Impact of risk minimization in patients treated with rosiglitazone‐containing products | 1777 | 2 | 2 | https://www.ncbi.nlm.nih.gov/pubmed/24068766 |
| Isotretinoin and the effectiveness of the pregnancy prevention program in Europe | 2474 | 5 | 3 | Link to study report included in EU PAS Register |
| Patterns and determinants of use of oral contraceptives in the EU | 2738 | 5 | 3 | https://www.ncbi.nlm.nih.gov/pubmed/26492444 |
| Monitoring the effectiveness of risk minimization in patients treated with pioglitazone‐containing products | 2765 | 3 | 3 | Link to study report included in EU PAS Register |
| Risk of cardiac valve disorders associated with the use of biphosphonates | 2616 | 6 | 3 | https://www.ncbi.nlm.nih.gov/pubmed/26694594 |
| Association between anxiolytic or hypnotic drugs and total mortality | 3772 | 2 | 2 | https://www.ncbi.nlm.nih.gov/pubmed/26256008 |
| Metformin use in renal impairment | 5249 | 2 | 2 |
http://bmjopen.bmj.com/content/5/9/e008531.full
https://www.ncbi.nlm.nih.gov/pubmed/27504911 |
| Study of regulatory communication and risk awareness following the article 31 referral of combined hormonal contraceptives in relation to thromboembolism | 21356 | n/ac | 6 | Study ongoing |
| Characterizing the risk of major bleeding in patients with nonvalvular atrial fibrillation: noninterventional study of patients taking direct oral anticoagulants in the EU | 16014 | 9 | 6 | Study ongoing |
| Study of utilization of combined hormonal contraceptives in Europe | 21352 | 3 | 3 | Study ongoing |
| Antimicrobial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by multidrug (MDR) Gram‐negative pathogens | 21359 | 1 | 5 | Study ongoing |
| Methods and data sources for determining long‐term effects of drug exposure during pregnancy, with application to antiepileptic medicines | 21171 | n/ad | 28 | Study ongoing |
| Impact of EU label changes for systemic diclofenac products: postreferral prescribing trends | Study planned | 4 | 3 | |
| Impact of EU label changes for hydroxyzine products: postreferral prescribing trends | Study planned | 4 | 3 |
a
Studies listed in chronological order.
b
The EU PAS Register search page is available at http://www.encepp.eu/encepp/studySearch.htm.
c
Not applicable: study using a survey design.
d
Not applicable: survey of available data sources in all EU Member states.