scholarly journals Investigator initiated clinical trials (IICTs): a systematic search in registries comparing Czech Republic and Portugal in terms of funding policies and scientific outcomes

2020 ◽  
Author(s):  
Catarina Madeira ◽  
Lenka Hořavová ◽  
Francisco dos Santos ◽  
Joana Batuca ◽  
Katerina Nebeska ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Czech Republic ◽  
Clinical Research ◽  
Systematic Search ◽  
European Countries ◽  
Level Of Evidence ◽  
Funding Policies ◽  
Funding Agencies ◽  
National Performance ◽  
Health Research Council

Abstract Background: Clinical trials provide one of the highest level of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. This study aims to compare, for the first time, two European Countries in terms of registered IICTs, respective funders, scientific outcome and its impact on the national performance in IICTs. Methods: A retrospective systematic search of registered IICTs, over the past 13 years, using four clinical trials registries was carried out in two European countries with similar population and Gross Domestic Product (GDP) but with different governmental models to fund clinical research. Each completed IICT was screened for sponsors, funders, type of intervention and associated publications. Results: IICTs involving Czech Republic and Portugal were n=439 (42 % with hospitals as sponsors) and n=328 (47 % with universities as sponsors), respectively. Funding agencies (national and international) supported only 25 % and 18 % of the IICTs in Czech Republic and Portugal, respectively. The Czech Ministry of Health, through the Health Research Council, supported 61 IICTs and the Portuguese Ministry of Science, Technology and High Education, through Fundação para a Ciência e Tecnologia , supported 27 IICTs. Among these, trials with investigational medicinal products represent 52 % (n= 32/61) and 4 % (n=1/27) in Czech Republic and Portugal, respectively. The Czech Republic presented a higher percentage of IICTs´ publications in high impact factor journals (IF>21) with national investigators as authors, when compared to Portugal (86 % vs 15 %). Conclusion: We found a better performance of Czech Republic in terms of number and scientific outcome of IICTs when compared to Portugal. These findings might be related to the existence of specific and periodic funding for clinical research in Czech Republic, although further data still need to be collected to confirm this relationship.

scholarly journals 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

2021 ◽  
Author(s):  
C. Madeira ◽  
L. Hořavová ◽  
F. dos Santos ◽  
J. R. Batuca ◽  
K. Nebeska ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Czech Republic ◽  
Clinical Research ◽  
Systematic Search ◽  
European Countries ◽  
The Czech Republic ◽  
Research Outcomes ◽  
Funding Policies ◽  
Funding Agencies ◽  
First Time

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.

scholarly journals Transparency and accuracy in funding investigator-initiated clinical trials: a systematic search in clinical trials databases

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023394 ◽  
Author(s):  
Catarina Madeira ◽  
Francisco Santos ◽  
Christine Kubiak ◽  
Jacques Demotes ◽  
Emília Carreira Monteiro
Keyword(s):  
Clinical Trials ◽  
Study Data ◽  
Systematic Search ◽  
Non Profit ◽  
Funding Sources ◽  
Funding Agencies ◽  
National Performance ◽  
Clinical Trials Registry ◽  
Design And Methods

ObjectivesThis study aims to identify the sources of funding for investigator-initiated clinical trials (IICTs) in Portugal, and to recommend ways to improve the quality of information collected from clinical trial databases about funding.Design and methodsA systematic search of trial registrations over the last 13 years—using the WHO International Clinical Trials Registry Platform (WHO-ICTRP) and four clinical trials registries (CTRs)—was carried out to identify IICTs in Portugal, used as a case study. Data from the databases were compared with data contained in publications to evaluate the consistency of information on funding sources. The term ‘database’ is used in this study to refer to both the WHO-ICTRP and the CTRs. When mentioned separately, the WHO-ICTRP is referred to as a ‘platform’, while the CTRs are referred to as ‘registries’.OutcomeSuggestions to improve clinical trials databases to clearly identify the funding sources and data ownership in IICTs.ResultsTwo hundred and eighty-two IICTs were identified in Portugal. Twenty per cent of trials were supported by industry with unclear information on the ownership of the results. Inaccuracy was found in the information about sponsors and funders. The information about funding in all resulting publications (77 out of 133 completed studies) was also inconsistent between databases in 35 out of 77 (45%) of the studies. Notably, 23% of the trials funded by non-profit organisations (n=226) received funds from international and/or national funding agencies.ConclusionsIdentification of IICT funding and ownership of results is unclear in the databases used for this study, which may lead to misunderstandings about the independence of the obtained results. Transparency and accuracy are desirable so that public decision makers and strategic partners can accurately evaluate national performance in this particular type of clinical research.

scholarly journals Obstacles in conducting clinical trials in the Saudi Arabia

2017 ◽  
Vol 4 (4) ◽  
pp. 166
Author(s):  
Salem D. Al Suwaidan ◽  
Aseel S. Alsuwaidan
Keyword(s):  
Clinical Trials ◽  
Saudi Arabia ◽  
Clinical Practice ◽  
Clinical Research ◽  
Strategic Plan ◽  
Good Clinical Practice ◽  
European Countries ◽  
Regulatory Authorities ◽  
Research Institution

<p class="abstract"><strong>Background:</strong> Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern.  It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.</p><p class="abstract"><strong>Methods:</strong> Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.</p><p><strong>Conclusions:</strong> To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.</p>

Clinical Research: Together, Stronger, Bolder

2012 ◽  
Vol 21 (4) ◽  
pp. 234-241 ◽  
Author(s):  
Martha A. Q. Curley
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Quantitative Research ◽  
Multidisciplinary Teams ◽  
Research Paradigm ◽  
Controlled Clinical Trials ◽  
Level Of Evidence ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Distinguished Research

Clinical inquiry is the ongoing process of questioning and evaluating practice, providing informed practice based on best-available data, and innovating practice though research. It is about noticing subtle differences at the bedside and asking “what if” questions. Critically ill patients and their families require care that is based on our best-available evidence. In the quantitative research paradigm, the highest level of evidence is derived from randomized controlled clinical trials. Currently, few adequately powered clinical trials support our practice, but this is changing. In critical care, clinical research should be conducted in the same manner as we practice, collaboratively within multidisciplinary teams. Our core value of the primacy of patient and family, our spirit of inquiry, and our passion for innovation centers our practice. During this year’s Distinguished Research Lecture, Martha Curley describes how together, we can build stronger, bolder clinical research.

Challenges to Conducting Multicenter Clinical Research

2008 ◽  
Vol 19 (2) ◽  
pp. 164-169
Author(s):  
Sharon Y. Irving ◽  
Martha A.Q. Curley
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Quantitative Research ◽  
Scientific Evidence ◽  
Internal Validity ◽  
Controlled Clinical Trials ◽  
Level Of Evidence ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Multicenter Clinical Trials

Nursing care provided to patients and their families should be based on strong scientific evidence. In the quantitative research paradigm, the highest level of evidence is derived from conclusive randomized controlled clinical trials. Multicenter clinical research allows the accrual of sufficient numbers of diverse participants in a shorter period of time and improves the generalizability of the study findings. Clinical research is inherently complex; the complexity exponentially increases when conducting multicenter clinical trials. Investigators are challenged to maintain the internal validity of the study and the sustained commitment and collaboration of numerous disciplines over the study period. This article presents 10 essential points to consider when conducting multicenter clinical research.

Addressing Research Ethics in Clinical Trials in Four of the Former Communist European Countries

2019 ◽  
pp. 127-147
Author(s):  
George Florian Macarie ◽  
Ana Voichita Tebeanu
Keyword(s):  
Clinical Trials ◽  
Data Analysis ◽  
Data Collection ◽  
Clinical Research ◽  
Research Ethics ◽  
Cultural Background ◽  
European Countries ◽  
East European ◽  
Ethical Norms ◽  
Communist Countries

This chapter considers the problematic of ethics in clinical research in the countries that are new in terms of implementation or building an adequate structure. The chapter intends to assess the extent to which the clinical trials performed in four former communist East-European countries considered the ethical norms into their research procedures. A framework of existing literature on ethics in clinical research, along with the regional context, is discussed in the next section. The methods section includes the instruments, sources, and procedures for data collection. The data analysis procedures and structure are further explained and grounded relative to the study main purpose. The next section includes the facts and figures on the presence of ethical requirements in clinical trials in the specific political and cultural background in a number of former European communist countries. Finally, a number of suggestions and recommendation are also discussed.

Bridging the Knowledge Gaps in Arrhythmogenic Cardiovascular Conditions: The Critical Role of Registries

2016 ◽  
Vol 10 (2) ◽  
pp. 1 ◽  
Author(s):  
Melody Hermel ◽  
Rebecca Duffy ◽  
Alexander Orfanos ◽  
Isabelle Hack ◽  
Shayna McEnteggart ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Natural History ◽  
Risk Stratification ◽  
Critical Role ◽  
Knowledge Gaps ◽  
Level Of Evidence ◽  
The Future

Cardiac registries have filled many gaps in knowledge related to arrhythmogenic cardiovascular conditions. Despite the less robust level of evidence available in registries when compared with clinical trials, registries have contributed a range of clinically useful information. In this review, the authors discuss the role that registries have played – related to diagnosis, natural history, risk stratification, treatment, and genetics of arrhythmogenic cardiovascular conditions – in closing knowledge gaps, and their role in the future.

INTERNATIONAL GRANT COOPERATION AS A TOOL FOR THE DEVELOPMENT OF PROFESSIONAL COMPETENCIES OF UNIVERSITY TEACHERS

2018 ◽  
pp. 4-8
Author(s):  
Milan Chmura
Keyword(s):  
Higher Education ◽  
Czech Republic ◽  
Professional Education ◽  
European Countries ◽  
International Project ◽  
The Czech Republic ◽  
University Teachers ◽  
Quality Of Higher Education ◽  
Education And Development

The education and development of university teachers have its justifcation and its importance is signifcant not only in the Czech Republic but also abroad. This study provides an analysis of further professional education of university teachers in the Czech Republic and in selected European countries. Subsequently, it presents an international project with participants from the Czech Republic, Ukraine, Slovakia and Poland, which, ultimately, plays a role in the improvement of the quality of higher education.

16th and 17th Workshops of the International Association of Vegetation Science Working Group for the European Vegetation Survey (Rome, Italy, 22-26 March 2007; Brno, Czech Republic, 1-5 May 2008)

2008 ◽  
pp. 131-133
Author(s):  
T. M. Lysenko ◽  
Yu. A. Semenishchenkov
Keyword(s):  
Czech Republic ◽  
Working Group ◽  
International Association ◽  
Botanical Garden ◽  
European Countries ◽  
Vegetation Survey ◽  
Vegetation Science ◽  
The University ◽  
Science Working

22-26 March 2007 in Rome (Italy), in the Botanical garden of the University «La Sapienza» hosted the 16th meeting of the Working group «Review of the Vegetation of Europe» of the International Association of Vegetation Science (IAVS). These meetings are held every spring in one of the European countries and dedicated to various topics.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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