TARGET-EU: Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks

Project information

• EU PE&PV research network
• EUPAS1000000539
• EUPAS1000000791
• Specific Contract 04 implementing Framework service contract EMA/2020/46/TDA/L5.06 

Full title

Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks (TARGET-EU)

Principal investigator

Prof. Dr. Olaf Klungel, Utrecht University (EU PE&PV lead)

Participating organisations

• Utrecht University, The Netherlands (consortium lead, project co-lead)
• University Medical Center Utrecht (UMCU), The Netherlands (project co-lead)
• Fundación FISABIO, Spain
• Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain
• Fundacio Hospital Universitari Vall d’Hebron Institut de Recerca (VHIR), Spain
• University Hospital Verona, Italy
• Vaccine monitoring Collaboration for Europe (VAC4EU)
• Electronic Health Records (EHR) Research Group, London School of Hygiene & Tropical Medicine (LSHTM)
• Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol, Spain
• Agenzia regionale di sanità della Toscana (ARS), Italy
• St. Antonius, The Netherlands
• Netherlands Comprehensive Cancer Organisation (IKNL), The Netherlands
• Democritus University of Thrace, Greece
• Teamit, Spain 

Status

Started in October 2024, ongoing

Deliverables

The protocols and reports of the 10 case studies will be published in the HMA/EMA Catalogues.

• TARGET-EU: Effectiveness of BNT162b2 mRNA COVID-19 vaccine in healthy individuals or with stable pre-existing medical conditions against SARS-CoV-2 infection (EUPAS1000000995)
• TARGET-EU: Nivolumab plus ipilimumab with chemotherapy versus pembrolizumab with chemotherapy in patients with non-oncogenic metastatic non-small-cell lung cancer with <1% PD- L1 tumour expression (EUPAS1000000987)
• TARGET-EU: Dapagliflozin and major adverse cardiovascular events in type 2 diabetes (EUPAS1000000979)
• TARGET-EU: Rivaroxaban and risk of major gastrointestinal bleeding in elderly patients with non-valvular atrial fibrillation (EUPAS1000001001)
• TARGET-EU: Comparison of single-device vilanterol/fluticasone furoate with other single-device inhaled corticosteroid and long-acting beta agonist combinations in the risk of pneumonia in adolescents with asthma (EUPAS1000000989)
• TARGET-EU: The risk of angiooedema and other safety events in heart failure patients treated with sacubitril/valsartan compared to angiotensin-converting enzyme inhibitors (EUPAS1000001002)
• TARGET-EU: Risk of adverse birth and neurodevelopmental outcomes in children born alive to fathers exposed to valproate versus levetiracetam for generalised epilepsy (EUPAS1000000999)
• TARGET-EU: Effectiveness of nirsevimab for RSV-lower respiratory tract infection hospitalization in infants ≤12 months of age (EUPAS1000000993)
• TARGET-EU: Tolvaptan and risk associated to hepatotoxicity in autosomal dominant polycystic kidney disease (EUPAS1000001005)
• TARGET-EU: Clinical benefit of bevacizumab in metastatic colorectal cancer (EUPAS1000000996)