Investigator Initiated Clinical Trials (IICTs): A Systematic
Search in Registries to Compare the Czech Republic and Portugal
in Terms of Funding Policies and Scientific Outcomes

J 2021

Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes

MADEIRA, C., Lenka HOŘAVOVÁ, F. DOS SANTOS, J. R. BATUCA, Kateřina NEBESKÁ et. al.

Basic information

Original name

Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes

Authors

MADEIRA, C., Lenka HOŘAVOVÁ (203 Czech Republic, belonging to the institution), F. DOS SANTOS, J. R. BATUCA, Kateřina NEBESKÁ (203 Czech Republic, belonging to the institution), Lenka SOUČKOVÁ (203 Czech Republic, belonging to the institution), C. KUBIAK, J. DEMOTES, Regina DEMLOVÁ (203 Czech Republic, belonging to the institution) and E. C. MONTEIRO (guarantor)

Edition

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, HEIDELBERG, SPRINGER HEIDELBERG, 2021, 2168-4790

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30104 Pharmacology and pharmacy

Country of publisher

Germany

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 1.337

RIV identification code

RIV/00216224:14110/21:00122133

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1007/s43441-021-00293-w

UT WoS

000651680000001

Keywords in English

Investigator initiated clinical trials; Funding; Clinical trials registry; Clinical research; Clinical trial; Clinical research outcome

Abstract

V originále

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.

Links

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(CEP code: EF16_013/0001826)

Name: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministry of Education, Youth and Sports of the CR, Priority axis 1: Strengthening capacities for high-quality research

90128, large research infrastructures

Name: CZECRIN III

Citovat

MADEIRA, C., Lenka HOŘAVOVÁ, F. DOS SANTOS, J. R. BATUCA, Kateřina NEBESKÁ, Lenka SOUČKOVÁ, C. KUBIAK, J. DEMOTES, Regina DEMLOVÁ and E. C. MONTEIRO. Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes. THERAPEUTIC INNOVATION & REGULATORY SCIENCE. HEIDELBERG: SPRINGER HEIDELBERG, 2021, vol. 55, No 5, p. 966-978. ISSN 2168-4790. Available from: https://dx.doi.org/10.1007/s43441-021-00293-w.

@article{1786890,
   author = {Madeira, C. and Hořavová, Lenka and dos Santos, F. and Batuca, J. R. and Nebeská, Kateřina and Součková, Lenka and Kubiak, C. and Demotes, J. and Demlová, Regina and Monteiro, E. C.},
   article_location = {HEIDELBERG},
   article_number = {5},
   doi = {http://dx.doi.org/10.1007/s43441-021-00293-w},
   keywords = {Investigator initiated clinical trials; Funding; Clinical trials registry; Clinical research; Clinical trial; Clinical research outcome},
   language = {eng},
   issn = {2168-4790},
   journal = {THERAPEUTIC INNOVATION & REGULATORY SCIENCE},
   title = {Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes},
   url = {https://link.springer.com/article/10.1007%2Fs43441-021-00293-w},
   volume = {55},
   year = {2021}
}

TY  - JOUR
ID  - 1786890
AU  - Madeira, C. - Hořavová, Lenka - dos Santos, F. - Batuca, J. R. - Nebeská, Kateřina - Součková, Lenka - Kubiak, C. - Demotes, J. - Demlová, Regina - Monteiro, E. C.
PY  - 2021
TI  - Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes
JF  - THERAPEUTIC INNOVATION & REGULATORY SCIENCE
VL  - 55
IS  - 5
SP  - 966-978
EP  - 966-978
PB  - SPRINGER HEIDELBERG
SN  - 21684790
KW  - Investigator initiated clinical trials
KW  - Funding
KW  - Clinical trials registry
KW  - Clinical research
KW  - Clinical trial
KW  - Clinical research outcome
UR  - https://link.springer.com/article/10.1007%2Fs43441-021-00293-w
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.
ER  -

MADEIRA, C., Lenka HOŘAVOVÁ, F. DOS SANTOS, J. R. BATUCA, Kateřina NEBESKÁ, Lenka SOUČKOVÁ, C. KUBIAK, J. DEMOTES, Regina DEMLOVÁ and E. C. MONTEIRO. Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes. \textit{THERAPEUTIC INNOVATION \&{}amp; REGULATORY SCIENCE}. HEIDELBERG: SPRINGER HEIDELBERG, 2021, vol.~55, No~5, p.~966-978. ISSN~2168-4790. Available from: https://dx.doi.org/10.1007/s43441-021-00293-w.

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