VACCELERATE Site Network: Real-time definition of clinical
study capacity in Europe

J 2023

VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe

SALMANTON-GARCIA, Jon, Pauline WIPFLER, Paula VALLE-SIMON, Christina MERAKOU, Ioannis KOPSIDAS et. al.

Základní údaje

Originální název

VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe

Autoři

SALMANTON-GARCIA, Jon, Pauline WIPFLER, Paula VALLE-SIMON, Christina MERAKOU, Ioannis KOPSIDAS, Ullrich BETHE, Angela STEINBACH, Orly SPIVAK, Lenka SOUČKOVÁ (203 Česká republika, domácí), Maria Amelia MENDONCA, Markela KONIORDOU, Margot HELLEMANS, Jesus FRIAS-INIESTA, Ruth Joanna DAVIS, Imre BARTA, Anna Maria AZZINI, Helena H ASKLING, Christos D ARGYROPOULOS, Elena ALVAREZ-BARCO, Murat AKOVA, Marc M J BONTEN, Miriam COHEN-KANDLI, Rebecca Jane COX, Robert FLISIAK, Petr HUSA (203 Česká republika, domácí), Ligita JANCORIENE, Alena KOSCALOVA, Odile LAUNAY, Jens LUNDGREN, Patrick MALLON, Laura MARQUES, Pontus NAUCLER, Jordi OCHANDO, Zoi-Dorothea PANA, Evelina TACCONELLI, Krisztina TOTH, Sven TRELLE, van Damme PIERRE, Theoklis E ZAOUTIS, Markus ZEITLINGER, Kerstin ALBUS, Fiona A STEWART, Sanne H I HOFSTRAAT, Patricia BRUIJNING-VERHAGEN a Oliver A CORNELY

Vydání

Vaccine, OXFORD, ELSEVIER SCI LTD, 2023, 0264-410X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30302 Epidemiology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 5.500 v roce 2022

Kód RIV

RIV/00216224:14110/23:00131303

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1016/j.vaccine.2023.05.006

UT WoS

001025964100001

Klíčová slova česky

SARS-CoV-2;registr;pandemická připravenost;vakcinační studie;místo;klinická síťl network

Klíčová slova anglicky

SARS-CoV-2; Registry; Pandemic preparedness; Vaccine trial; Site; Clinical network

Štítky

14110214, 14110516, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 29. 1. 2024 14:47, Mgr. Tereza Miškechová

Anotace

V originále

Background: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. Methods: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experi-ence, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clin-ical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study char-acteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selec-tion process. Results: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppres-sion by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in sev-eral indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interven-tional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxovindae/in-fluenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. Conclusions: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe. & COPY; 2023 The Authors. Published by Elsevier Ltd.

Návaznosti

90249, velká výzkumná infrastruktura

Název: CZECRIN IV

Citovat

SALMANTON-GARCIA, Jon, Pauline WIPFLER, Paula VALLE-SIMON, Christina MERAKOU, Ioannis KOPSIDAS, Ullrich BETHE, Angela STEINBACH, Orly SPIVAK, Lenka SOUČKOVÁ, Maria Amelia MENDONCA, Markela KONIORDOU, Margot HELLEMANS, Jesus FRIAS-INIESTA, Ruth Joanna DAVIS, Imre BARTA, Anna Maria AZZINI, Helena H ASKLING, Christos D ARGYROPOULOS, Elena ALVAREZ-BARCO, Murat AKOVA, Marc M J BONTEN, Miriam COHEN-KANDLI, Rebecca Jane COX, Robert FLISIAK, Petr HUSA, Ligita JANCORIENE, Alena KOSCALOVA, Odile LAUNAY, Jens LUNDGREN, Patrick MALLON, Laura MARQUES, Pontus NAUCLER, Jordi OCHANDO, Zoi-Dorothea PANA, Evelina TACCONELLI, Krisztina TOTH, Sven TRELLE, van Damme PIERRE, Theoklis E ZAOUTIS, Markus ZEITLINGER, Kerstin ALBUS, Fiona A STEWART, Sanne H I HOFSTRAAT, Patricia BRUIJNING-VERHAGEN a Oliver A CORNELY. VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe. Vaccine. OXFORD: ELSEVIER SCI LTD, 2023, roč. 41, č. 26, s. 3915-3922. ISSN 0264-410X. Dostupné z: https://dx.doi.org/10.1016/j.vaccine.2023.05.006.

@article{2299130,
   author = {SalmantonandGarcia, Jon and Wipfler, Pauline and ValleandSimon, Paula and Merakou, Christina and Kopsidas, Ioannis and Bethe, Ullrich and Steinbach, Angela and Spivak, Orly and Součková, Lenka and Mendonca, Maria Amelia and Koniordou, Markela and Hellemans, Margot and FriasandIniesta, Jesus and Davis, Ruth Joanna and Barta, Imre and Azzini, Anna Maria and Askling, Helena H and Argyropoulos, Christos D and AlvarezandBarco, Elena and Akova, Murat and Bonten, Marc M J and CohenandKandli, Miriam and Cox, Rebecca Jane and Flisiak, Robert and Husa, Petr and Jancoriene, Ligita and Koscalova, Alena and Launay, Odile and Lundgren, Jens and Mallon, Patrick and Marques, Laura and Naucler, Pontus and Ochando, Jordi and Pana, ZoiandDorothea and Tacconelli, Evelina and Toth, Krisztina and Trelle, Sven and Pierre, van Damme and Zaoutis, Theoklis E and Zeitlinger, Markus and Albus, Kerstin and Stewart, Fiona A and Hofstraat, Sanne H I and BruijningandVerhagen, Patricia and Cornely, Oliver A},
   article_location = {OXFORD},
   article_number = {26},
   doi = {http://dx.doi.org/10.1016/j.vaccine.2023.05.006},
   keywords = {SARS-CoV-2; Registry; Pandemic preparedness; Vaccine trial; Site; Clinical network},
   language = {eng},
   issn = {0264-410X},
   journal = {Vaccine},
   title = {VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe},
   url = {https://www.sciencedirect.com/science/article/pii/S0264410X23005236?via%3Dihub},
   volume = {41},
   year = {2023}
}

TY  - JOUR
ID  - 2299130
AU  - Salmanton-Garcia, Jon - Wipfler, Pauline - Valle-Simon, Paula - Merakou, Christina - Kopsidas, Ioannis - Bethe, Ullrich - Steinbach, Angela - Spivak, Orly - Součková, Lenka - Mendonca, Maria Amelia - Koniordou, Markela - Hellemans, Margot - Frias-Iniesta, Jesus - Davis, Ruth Joanna - Barta, Imre - Azzini, Anna Maria - Askling, Helena H - Argyropoulos, Christos D - Alvarez-Barco, Elena - Akova, Murat - Bonten, Marc M J - Cohen-Kandli, Miriam - Cox, Rebecca Jane - Flisiak, Robert - Husa, Petr - Jancoriene, Ligita - Koscalova, Alena - Launay, Odile - Lundgren, Jens - Mallon, Patrick - Marques, Laura - Naucler, Pontus - Ochando, Jordi - Pana, Zoi-Dorothea - Tacconelli, Evelina - Toth, Krisztina - Trelle, Sven - Pierre, van Damme - Zaoutis, Theoklis E - Zeitlinger, Markus - Albus, Kerstin - Stewart, Fiona A - Hofstraat, Sanne H I - Bruijning-Verhagen, Patricia - Cornely, Oliver A
PY  - 2023
TI  - VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe
JF  - Vaccine
VL  - 41
IS  - 26
SP  - 3915-3922
EP  - 3915-3922
PB  - ELSEVIER SCI LTD
SN  - 0264410X
KW  - SARS-CoV-2
KW  - Registry
KW  - Pandemic preparedness
KW  - Vaccine trial
KW  - Site
KW  - Clinical network
UR  - https://www.sciencedirect.com/science/article/pii/S0264410X23005236?via%3Dihub
N2  - Background: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. Methods: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experi-ence, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clin-ical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study char-acteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selec-tion process. Results: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppres-sion by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in sev-eral indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interven-tional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxovindae/in-fluenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. Conclusions: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe. & COPY; 2023 The Authors. Published by Elsevier Ltd.
ER  -

SALMANTON-GARCIA, Jon, Pauline WIPFLER, Paula VALLE-SIMON, Christina MERAKOU, Ioannis KOPSIDAS, Ullrich BETHE, Angela STEINBACH, Orly SPIVAK, Lenka SOUČKOVÁ, Maria Amelia MENDONCA, Markela KONIORDOU, Margot HELLEMANS, Jesus FRIAS-INIESTA, Ruth Joanna DAVIS, Imre BARTA, Anna Maria AZZINI, Helena H ASKLING, Christos D ARGYROPOULOS, Elena ALVAREZ-BARCO, Murat AKOVA, Marc M J BONTEN, Miriam COHEN-KANDLI, Rebecca Jane COX, Robert FLISIAK, Petr HUSA, Ligita JANCORIENE, Alena KOSCALOVA, Odile LAUNAY, Jens LUNDGREN, Patrick MALLON, Laura MARQUES, Pontus NAUCLER, Jordi OCHANDO, Zoi-Dorothea PANA, Evelina TACCONELLI, Krisztina TOTH, Sven TRELLE, van Damme PIERRE, Theoklis E ZAOUTIS, Markus ZEITLINGER, Kerstin ALBUS, Fiona A STEWART, Sanne H I HOFSTRAAT, Patricia BRUIJNING-VERHAGEN a Oliver A CORNELY. VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe. \textit{Vaccine}. OXFORD: ELSEVIER SCI LTD, 2023, roč.~41, č.~26, s.~3915-3922. ISSN~0264-410X. Dostupné z: https://dx.doi.org/10.1016/j.vaccine.2023.05.006.

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