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
Language English Country Switzerland Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
Grant support
CZECRIN_4 PACIENTY (No. CZ.02.1.01/0.0/0.0/16_013/0001826)
European Regional Development Fund
CZECRIN - LM2015090
Large Research infrastructure
Portaria nº 237/2014
Fundação para a Ciência e a Tecnologia
PubMed
34003473
PubMed Central
PMC8332583
DOI
10.1007/s43441-021-00293-w
PII: 10.1007/s43441-021-00293-w
Knihovny.cz E-resources
- Keywords
- Clinical research, Clinical research outcome, Clinical trial, Clinical trials registry, Funding, Investigator initiated clinical trials,
- MeSH
- Humans MeSH
- Policy * MeSH
- Registries MeSH
- Retrospective Studies MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
- Portugal MeSH
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.
Chronic Diseases Research Centre NOVA Medical School Universidade NOVA de Lisboa Lisbon Portugal
Comprehensive Health Research Centre Lisbon Portugal
Department of Clinical Trials Masaryk Memorial Cancer Institute Brno Brno Czech Republic
Department of Pharmacology Faculty of Medicine Masaryk University Brno Czech Republic
European Clinical Research Infrastructure Network Paris France
Portuguese Clinical Research Infrastructure Network Lisbon Portugal
University Hospital St Anne's Brno International Clinical Research Centre Brno Czech Republic
See more in PubMed
Konwar M, Bose D, Gogtay NJ, Thatte UM. Investigator-initiated studies: challenges and solutions. Perspect Clin Res. 2018;9(4):179–183. doi: 10.4103/picr.PICR_106_18. PubMed DOI PMC
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research—a systematic review. JAMA. 2003;289(4):454–465. doi: 10.1001/jama.289.4.454. PubMed DOI
Crowe S, Fenton M, Hall M, Cowan K, Chalmers I. Patients’, clinicians’ and the research communities’ priorities for treatment research: there is an important mismatch. Res Involv Engagem. 2015;1:2. doi: 10.1186/s40900-015-0003-x. PubMed DOI PMC
Madeira C, Pais A, Kubiak C, Demotes J, Monteiro EC. Investigator-initiated clinical trials conducted by the Portuguese Clinical Research Infrastructure Network (PtCRIN) Contemp Clin Trials Commun. 2016;4:141–148. doi: 10.1016/j.conctc.2016.08.002. PubMed DOI PMC
Madeira C, Santos F, Kubiak C, Demotes J, Monteiro EC. Transparency and accuracy in funding investigator initiated clinical trials: a systematic search in clinical trials databases. BMJ Open. 2019;9:e023394. doi: 10.1136/bmjopen-2018-023394. PubMed DOI PMC
Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on trial registration 11 years after the ICMJE policy was established. NEJM. 2017;376(4):383–391. doi: 10.1056/NEJMsr1601330. PubMed DOI PMC
Fundação para a ciência e Tecnologia, Concurso de Projectos de I&D em Investigação Clínica. https://www.fct.pt/apoios/projectos/concursos/invclinica/. Accessed Oct 2019.
Almeida N, Romãozinho JM, Donato MM, Luxo C, Cardoso O, Cipriano MA, Marinho C, Sofia C. Triple therapy with high-dose proton-pump inhibitor, amoxicillin, and doxycycline is useless for Helicobacter pylori eradication: a proof-of-concept study. Helicobacter. 2014;19(2):90–97. doi: 10.1111/hel.12106. PubMed DOI
European Clinical Research Infrastructure Network (ECRIN). https://www.ecrin.org/activities/trial-management. Assessed Oct 2019.
Roadmap for Large Research, Development and Innovation Infrastructures in the Czech Republic—Update 2011. https://www.vyzkumne-infrastruktury.cz/wp-content/uploads/2019/06/Cestovní-mapa-velkých-výzkumných-infrastruktur-ČR_2011_EN.pdf. Accessed July 2019.
Resolução do Conselho de Ministros (RCM) nº 18/2015, Diário da República, 1.ª série — N.º 67 — 7 de abril de 2015. https://dre.pt/web/guest/pesquisa/-/search/66902772/details/maximized. Accessed Sept 2019.
Despacho n.º 7216/2015, Diário da República, 2.ª série — N.º 126 — 1 de julho de 2015. https://dre.pt/home/-/dre/67644371/details/maximized. Accessed Oct 2019.
Portaria n.º 237/2014, Gabinetes do Secretário de Estado Adjunto e do Orçamento e da Secretária de Estado da Ciência - Diário da República, 2.ª série — N.º 60 — 26 de março de 2014. https://www.acm.gov.pt/documents/10181/43818/Aviso+n.%C2%BA+4107-2014.pdf/aa89bcc8-4e1a-4110-a92d-0a8f9eb6b182. Accessed Sept 2019.
Decision Ref. No. :MSMT-3495/2014.
Act. No. 378/2007 Coll., Decree No. 226/2008 Coll.
Clinical Investigator Certificate. http://clic.pharmaceutical-medicine.pt/. Accessed Oct 2019.
Portugal Clinical Scholars Research Training. https://postgraduateeducation.hms.harvard.edu/certificate-programs/custom-programs/portugal-clinical-scholars-research-training. Assessed Oct 2019.
Resolução do Conselho de Ministros (RCM) n.º 20/2016, Diário da República, 1.ª série — N.º 70 — 11 de abril de 2016. https://data.dre.pt/eli/resolconsmin/20/2016/04/11/p/dre/pt/html. Accessed Sept 2019.
Czech Health Research Council (AZV). http://www.azvcr.cz/en. Assessed Oct 2019.
Czech Publication by AZV Director About the Establishment of the Czech Health Research Council. https://www.tribune.cz/clanek/40308-agentura-pro-zdravotnicky-vyzkum-ceske-republiky. Assessed Oct 2019.
Atal I, Trinquart L, Porcher R, Ravaud P. Differential globalization of industry- and non industry-sponsored clinical trials. PLoS ONE. 2015;10(12):e0145122. doi: 10.1371/journal.pone.0145122. PubMed DOI PMC
von Niederhäusern B, Magnin A, Pauli-Magnus C. The impact of clinical trial units on the value of clinical research in Switzerland. Swiss Med Wkly. 2018;148:w14615. doi: 10.4414/smw.2018.14615. PubMed DOI
Maier-Lenz H. Academic strength in Germany, Applied Clinical Trials 2011. http://www.appliedclinicaltrialsonline.com/academic-strength-germany. Accessed Oct 2019.
Despacho n.º 4157/2019; Diário da República, 2.ª série — N.º 75 — 16 de abril de 2019. https://dre.pt/home/-/dre/122109185/details/maximized. Accessed Oct 2019.
Innovation Fund Denmark. https://innovationsfonden.dk/en. Accessed Oct 2019.
Fox L, Toms C, Kernaghan S, Snowdon C, Bliss JM. Conducting non-commercial international clinical trials: the ICR-CTSU experience. Trials. 2017;18:440. doi: 10.1186/s13063-017-2176-0. PubMed DOI PMC
Neyt M, Christiaens T, Demotes J, Walley T, Hulstaert F. Publicly funded practice-oriented clinical trials: of importance for healthcare payers. J Comp Eff Res. 2016;5(6):551–560. doi: 10.2217/cer-2016-0018. PubMed DOI
Neyt M, Christiaens T, Demotes J, Hulstaert F. Publicly funded Practice-oriented Clinical Trials. Health Services Research (HSR) Brussels: Belgian Health Care Knowledge Centre (KCE). KCE Reports 2015; 246. D/2015/10.273/53.
Italian Medicines Agency R, Development Working Group Feasibility and challenges of independent research on drugs: the Italian medicines agency (AIFA) experience. Eur J Clin Investig. 2010 doi: 10.1111/j.1365-2362.2009.02226.x. PubMed DOI
Clinical Trials Directive 2001/20/EC, European Commission. https://ec.europa.eu/health/human-use/clinical-trials/directive_pt. Accessed Oct 2019.
EudraCT Public Home Page. https://eudract.ema.europa.eu/. Accessed Sept 2019.