Literature DB >> 34003473

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.

C Madeira1,2,3,4, L Hořavová5,6, F Dos Santos2, J R Batuca1,2,3, K Nebeska1,5, L Součková1,5,7,8, C Kubiak1, J Demotes1, R Demlová5,7,8, E C Monteiro9,10.   

Abstract

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.

Entities:  

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

Year:  2021        PMID: 34003473     DOI: 10.1007/s43441-021-00293-w

Source DB:  PubMed          Journal:  Ther Innov Regul Sci        ISSN: 2168-4790            Impact factor:   1.778


  10 in total

Review 1.  Scope and impact of financial conflicts of interest in biomedical research: a systematic review.

Authors:  Justin E Bekelman; Yan Li; Cary P Gross
Journal:  JAMA       Date:  2003 Jan 22-29       Impact factor: 56.272

2.  Triple therapy with high-dose proton-pump inhibitor, amoxicillin, and doxycycline is useless for Helicobacter pylori eradication: a proof-of-concept study.

Authors:  Nuno Almeida; José M Romãozinho; Maria M Donato; Cristina Luxo; Olga Cardoso; Maria A Cipriano; Carol Marinho; Carlos Sofia
Journal:  Helicobacter       Date:  2014-02-10       Impact factor: 5.753

3.  Publicly funded practice-oriented clinical trials: of importance for healthcare payers.

Authors:  Mattias Neyt; Thierry Christiaens; Jacques Demotes; Tom Walley; Frank Hulstaert
Journal:  J Comp Eff Res       Date:  2016-09-05       Impact factor: 1.744

4.  Update on Trial Registration 11 Years after the ICMJE Policy Was Established.

Authors:  Deborah A Zarin; Tony Tse; Rebecca J Williams; Thiyagu Rajakannan
Journal:  N Engl J Med       Date:  2017-01-26       Impact factor: 91.245

5.  Patients', clinicians' and the research communities' priorities for treatment research: there is an important mismatch.

Authors:  Sally Crowe; Mark Fenton; Matthew Hall; Katherine Cowan; Iain Chalmers
Journal:  Res Involv Engagem       Date:  2015-06-25

6.  Investigator-initiated clinical trials conducted by the Portuguese Clinical Research Infrastructure Network (PtCRIN).

Authors:  C Madeira; A Pais; C Kubiak; J Demotes; E C Monteiro
Journal:  Contemp Clin Trials Commun       Date:  2016-08-20

7.  Conducting non-commercial international clinical trials: the ICR-CTSU experience.

Authors:  Lisa Fox; Christy Toms; Sarah Kernaghan; Claire Snowdon; Judith M Bliss
Journal:  Trials       Date:  2017-09-26       Impact factor: 2.279

8.  Investigator-initiated studies: Challenges and solutions.

Authors:  Mahanjit Konwar; Debdipta Bose; Nithya J Gogtay; Urmila M Thatte
Journal:  Perspect Clin Res       Date:  2018 Oct-Dec

9.  Transparency and accuracy in funding investigator-initiated clinical trials: a systematic search in clinical trials databases.

Authors:  Catarina Madeira; Francisco Santos; Christine Kubiak; Jacques Demotes; Emília Carreira Monteiro
Journal:  BMJ Open       Date:  2019-05-14       Impact factor: 2.692

10.  Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

Authors:  Ignacio Atal; Ludovic Trinquart; Raphaël Porcher; Philippe Ravaud
Journal:  PLoS One       Date:  2015-12-14       Impact factor: 3.240

  10 in total

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