Editors across all disciplines and approaches ask the same questions to reviewers and judge the merit of a study against a similar checklist: is the study well designed and does it provide reliable findings? Have we learnt something new? Are the results relevant to the community of scientists and/or medical professionals? In short, does the study make an important contribution to existing knowledge? As clinical practice has become increasingly evidence-based, the number of clinical trials has increased significantly (Presently, 6500 trials with ‘heart’ as keyword are registered and are open or recruiting; www.clinicaltrials.gov.) and stringent criteria have been put into place to guide the design, execution, and analysis of clinical investigations.These are the standards of good clinical practice (“GCP is an international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, and that clinical-trial data are credible”; http://www.ema.europa.eu/ema/index.jsp?curl=pages/ regulation/general/general_content_000072.jsp). Training courses are available to educate clinicians in GCP and the management of patient based studies. In the past 10 years, the impact factor of journals that focus on clinical research has steadily increased, due, to a large extent, to the recognition that large, well-designed clinical trials are able to produce robust findings that are immediately relevant to patient management and underpin practice guidelines. (The AHA and ACC published more than 70 guidelines in their journals since 2005; http://my.americanheart.org/professional/StatementsGuidelines, and the ESC similarly published more than 30; http://www.escardio.org/guidelinessurveys/ esc-guidelines/Pages/GuidelinesList.aspx.) Not surprisingly, this results in widespread citation of the work, reflecting its impact on the community. The care in the design, conduct, and analysis of a clinical trial, and the subsequent further scrutiny in meta-analysis, outcome research, and registries are motivated by the high values at stake, namely the direct impact on patient outcome and quality of life. The values at stake may not seem that high for experimental studies but ultimately they are. Misleading results can lead other researchers to pursue unrewarding avenues of research, and wrong results may take many years to redress. Among reasons for retraction, doubt about data is a major factor and lack of reproducibility amajor concern. In particular, given the aspiration that findings in animal models will ultimately inform our understanding and management of disease states in humans, it is important to carefully consider the current standards in bench research.

Bedside to bench: a look at experimental research with a clinical trial checklist / Sipido, Kr; Casadei, B; Holvoet, P; Janssens, S; Luttun, A; Sampaolesi, Maurilio. - In: CARDIOVASCULAR RESEARCH. - ISSN 1755-3245. - 101(2014), pp. 1-3. [10.1093/cvr/cvt272]

Bedside to bench: a look at experimental research with a clinical trial checklist

SAMPAOLESI, MAURILIO
2014

Abstract

Editors across all disciplines and approaches ask the same questions to reviewers and judge the merit of a study against a similar checklist: is the study well designed and does it provide reliable findings? Have we learnt something new? Are the results relevant to the community of scientists and/or medical professionals? In short, does the study make an important contribution to existing knowledge? As clinical practice has become increasingly evidence-based, the number of clinical trials has increased significantly (Presently, 6500 trials with ‘heart’ as keyword are registered and are open or recruiting; www.clinicaltrials.gov.) and stringent criteria have been put into place to guide the design, execution, and analysis of clinical investigations.These are the standards of good clinical practice (“GCP is an international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, and that clinical-trial data are credible”; http://www.ema.europa.eu/ema/index.jsp?curl=pages/ regulation/general/general_content_000072.jsp). Training courses are available to educate clinicians in GCP and the management of patient based studies. In the past 10 years, the impact factor of journals that focus on clinical research has steadily increased, due, to a large extent, to the recognition that large, well-designed clinical trials are able to produce robust findings that are immediately relevant to patient management and underpin practice guidelines. (The AHA and ACC published more than 70 guidelines in their journals since 2005; http://my.americanheart.org/professional/StatementsGuidelines, and the ESC similarly published more than 30; http://www.escardio.org/guidelinessurveys/ esc-guidelines/Pages/GuidelinesList.aspx.) Not surprisingly, this results in widespread citation of the work, reflecting its impact on the community. The care in the design, conduct, and analysis of a clinical trial, and the subsequent further scrutiny in meta-analysis, outcome research, and registries are motivated by the high values at stake, namely the direct impact on patient outcome and quality of life. The values at stake may not seem that high for experimental studies but ultimately they are. Misleading results can lead other researchers to pursue unrewarding avenues of research, and wrong results may take many years to redress. Among reasons for retraction, doubt about data is a major factor and lack of reproducibility amajor concern. In particular, given the aspiration that findings in animal models will ultimately inform our understanding and management of disease states in humans, it is important to carefully consider the current standards in bench research.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1582005
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