TY - JOUR
T1 - Investigator Initiated Clinical Trials (IICTs)
T2 - A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes
AU - Madeira, C.
AU - Hořavová, L.
AU - dos Santos, F.
AU - Batuca, J. R.
AU - Nebeska, K.
AU - Součková, L.
AU - Kubiak, C.
AU - Demotes, J.
AU - Demlová, R.
AU - Monteiro, E. C.
N1 - Funding: In the Czech Republic, this work was supported by the European Regional Development Fund - Project CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826) and Large Research infrastructure CZECRIN – LM2015090. CM and FS were supported by Fundação para a Ciência e a Tecnologia (FCT, through the membership fees to ECRIN-ERIC published at Portaria nº 237/2014). The funders did not interfere with the design of the study, collection, analysis and interpretation of data as well as with the writing of the manuscript.
PY - 2021/9
Y1 - 2021/9
N2 - Objectives: Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes. Methods: A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed. Results: IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs’ publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%). Conclusion: The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.
AB - Objectives: Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes. Methods: A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed. Results: IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs’ publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%). Conclusion: The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.
KW - Clinical research
KW - Clinical research outcome
KW - Clinical trial
KW - Clinical trials registry
KW - Funding
KW - Investigator initiated clinical trials
UR - http://www.scopus.com/inward/record.url?scp=85106313065&partnerID=8YFLogxK
U2 - 10.1007/s43441-021-00293-w
DO - 10.1007/s43441-021-00293-w
M3 - Article
C2 - 34003473
AN - SCOPUS:85106313065
SN - 2168-4790
SP - 966
EP - 978
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
ER -
