The group is a partner of the European Consortium "European Pharmacoepidemiology and Pharmacovigilance Network". During 2021 we started a non-financed study on the use of non-specific immunoglobulins at three Catalan hospitals. Regarding to COVID-19, we started a collaboration with the Preventive Medicine and Public Health Department on two clinical trials on COVID-19 vaccines: a)  Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial; b) a phase IIb, double-blind, randomised, active controlled, multicentre, non-inferiority trial followed by a phase III, single-arm, open-label trial to assess immunogenicity and safety of a booster vaccination against sars-cov-2 in adults fully vaccinated against covid-19. Our group has also continued the international training activities through its participation in the European master in pharmacoepidemiology and hosting fellow researchers.

Group Leader
Maria Antònia Agustí Escasany

Principal Investigator (PI)
Mònica Sabaté Gallego, Immaculada Danés Carreras i Glòria Cereza García.

Researchers
Xavier Vidal Guitart, Cristina Aguilera Martín, Montserrat Bosch Ferrer, Núria Garcia Doladé, Carmen Asensio Ostos, Eulàlia Pérez Esquirol, Elena Ballarín Alins, Eduard Diogène Fadini, Lourdes Vendrell Bosch, Angela Mesas Idánez i Francisco Javier Medel Rebollo

PhD Students
Lina Camacho Arteaga, Jean-Marie Vianney Habarugia, Carolina Iglesias López, Kristopher Amaro Hosey, Lina Leguizamo, Carla Sans Pola, Judit Riera Arnau, Gustavo Molina Molina i Emilie Anderssen Nordalh

Nursing and Technical Staff
José J Barroso García i Montse Pérez González

28

PUBLICATIONS

195

IMPACT FACTOR

6.96

AVERAGE IMPACT FACTOR

SELECTED ARTICLES

Borobia AM, Carcas AJ, Pérez-Olmeda M, Castaño L, Bertran MJ, García-Pérez J, Campins M, Portolés A, González-Pérez M, García Morales MT, Arana-Arri E, Aldea M, Díez-Fuertes F, Fuentes I, Ascaso A, Lora D, Imaz-Ayo N, Barón-Mira LE, Agustí A, Pérez-Ingidua C, Gómez de la Cámara A, Arribas JR, Ochando J, Alcamí J, Belda-Iniesta C, Frías J; CombiVacS Study Group.
Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial.
Lancet. 2021 Jul 10;398(10295):121-130.
DOI: doi: 10.1016/S0140-6736(21)01420-3.
IF: 79.32

Iglesias-Lopez C, Agustí A, Vallano A, Obach M
Current landscape of clinical development and approval of advanced therapies.
Mol Ther Methods Clin Dev. 2021 Nov 11;23:606-618.
DOI: doi: 10.1016/j.omtm.2021.11.003.
IF: 6.70

Sabaté M, Vidal X, Ballarin E, Rottenkolber M, Schmiedl S, Grave B, Huerta C, Martin-Merino E, Montero D, Leon-Muñoz LM, Gasse C, Moore N, Droz C, Lassalle R, Aakjær M, Andersen M, De Bruin ML, Souverein P, Klungel OH, Gardarsdottir H, Ibáñez L.
Adherence to Direct Oral Anticoagulants in Patients With Non-Valvular Atrial Fibrillation: A Cross-National Comparison in Six European Countries (2008-2015).
Front Pharmacol. 2021 Nov 3;12:682890.
DOI: doi: 10.3389/fphar.2021.682890.
IF: 5.81

Aguilera C, Agustí A, Pérez E, Gracia RM, Diogène E, Danés I.
Spontaneously Reported Adverse Drug Reactions and Their Description in Hospital Discharge Reports: A Retrospective Study.
J Clin Med. 2021 Jul 26;10(15):3293.
DOI: doi: 10.3390/jcm10153293.
IF: 4.24

Amaro-Hosey K, Danés I, Vendrell L, Alonso L, Renedo B, Gros L, Vidal X, Cereza G, Agustí A.
Adverse Reactions to Drugs of Special Interest in a Pediatric Oncohematology Service.
Front Pharmacol. 2021 May 5;12:670945.
DOI: doi: 10.3389/fphar.2021.670945
IF: 5.81

Detección de falsos positivos en pacientes con alertas electrónicas de alergia a betalactámicos en las historias clínicas.
Principal Investigator: Victòria Cardona Dahl
Agency: ISCIII-FIS PI19/01656
Funding: 36,330€
Period: 2020-2022

Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends
Principal Investigator: Olaf Klungel, Miriam Sturkenboom
Agency: European Medicines Agency
Funding: 249,500 €
Period: 2020-2022

COVID-19 infection and medicines in pregnancy – a multinational registry based study (CONSIGN)
Principal Investigator: Miriam Sturkenboom, Olaf Klungel and Hedvig Nordeng
Agency: European Medicines Agency /2018/28PE (Lot4)
Funding: 548,890€
Period: 2020-2022

Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial
Principal Investigator: Magdalena Campins martí
Agency: Instituto de Salud Carlos III.
Funding: -
Period: 2021-2022

A phase IIB, double-blind, randomized, active controlled, multicentre, non-inferiority trial followed by a phase III, single-arm, open-label trial to assess immunogenicity and safety of a booster vaccination with a recombinant protein RBD fusion dimer candidate (PHH-1V) against SARS-CoV-2 in adults fully vaccinated against Covid-19 (HIPRA-HH-2).
Principal Investigator: Susana Otero Romero
Agency: HIPRA SCIENTIFIC, S.L.U
Funding: 200.620,8
Period: 2021-2022