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Planning preclinica...
Planning preclinical confirmatory multicenter trials to strengthen translation from basic to clinical research : a multi-stakeholder workshop report
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Drude, Natascha Ingrid (author)
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Martinez-Gamboa, Lorena (author)
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Danziger, Meggie (author)
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Collazo, Anja (author)
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Kniffert, Silke (author)
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Wiebach, Janine (author)
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- Nilsonne, Gustav, 1982- (author)
- Stockholms universitet,Stressforskningsinstitutet
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Konietschke, Frank (author)
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Piper, Sophie K. (author)
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Pawel, Samuel (author)
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Micheloud, Charlotte (author)
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Held, Leonhard (author)
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Frommlet, Florian (author)
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Segelcke, Daniel (author)
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Pogatzki-Zahn, Esther M. (author)
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Voelkl, Bernhard (author)
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Friede, Tim (author)
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Brunner, Edgar (author)
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Dempfle, Astrid (author)
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Haller, Bernhard (author)
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Jung, Marie Juliane (author)
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Riecken, Lars Björn (author)
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Kuhn, Hans-Georg (author)
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Tenbusch, Matthias (author)
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Higuita, Lina Maria Serna (author)
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Remarque, Edmond J. (author)
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Grüninger-Egli, Servan Luciano (author)
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Manske, Katrin (author)
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Kobold, Sebastian (author)
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Rivalan, Marion (author)
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Wedekind, Lisa (author)
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Wilcke, Juliane C. (author)
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Boulesteix, Anne-Laure (author)
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Meinhardt, Marcus W. (author)
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Spanagel, Rainer (author)
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Hettmer, Simone (author)
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von Lüttichau, Irene (author)
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Regina, Carla (author)
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Dirnagl, Ulrich (author)
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Toelch, Ulf (author)
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(creator_code:org_t)
- 2022-11-07
- 2022
- English.
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In: Translational Medicine Communications. - : Springer Nature. - 2396-832X. ; 7:1
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
Close
- Clinical translation from bench to bedside often remains challenging even despite promising preclinical evidence. Among many drivers like biological complexity or poorly understood disease pathology, preclinical evidence often lacks desired robustness. Reasons include low sample sizes, selective reporting, publication bias, and consequently inflated effect sizes. In this context, there is growing consensus that confirmatory multicenter studies -by weeding out false positives- represent an important step in strengthening and generating preclinical evidence before moving on to clinical research. However, there is little guidance on what such a preclinical confirmatory study entails and when it should be conducted in the research trajectory. To close this gap, we organized a workshop to bring together statisticians, clinicians, preclinical scientists, and meta-researcher to discuss and develop recommendations that are solution-oriented and feasible for practitioners. Herein, we summarize and review current approaches and outline strategies that provide decision-critical guidance on when to start and subsequently how to plan a confirmatory study. We define a set of minimum criteria and strategies to strengthen validity before engaging in a confirmatory preclinical trial, including sample size considerations that take the inherent uncertainty of initial (exploratory) studies into account. Beyond this specific guidance, we highlight knowledge gaps that require further research and discuss the role of confirmatory studies in translational biomedical research. In conclusion, this workshop report highlights the need for close interaction and open and honest debate between statisticians, preclinical scientists, meta-researchers (that conduct research on research), and clinicians already at an early stage of a given preclinical research trajectory.
Subject headings
- SAMHÄLLSVETENSKAP -- Psykologi (hsv//swe)
- SOCIAL SCIENCES -- Psychology (hsv//eng)
Keyword
- confirmatory preclinical studies
- confirmatory preclinical multicenter studies
- preclinical multicenter studies
- robust evidence
- reproducibility
- clinical translation
- translational biomedical research
- multi-stakeholder workshop
- psykologi
- Psychology
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Drude, Natascha ...
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Martinez-Gamboa, ...
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Danziger, Meggie
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Collazo, Anja
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Kniffert, Silke
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Wiebach, Janine
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show more...
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Nilsonne, Gustav ...
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Konietschke, Fra ...
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Piper, Sophie K.
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Pawel, Samuel
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Micheloud, Charl ...
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Held, Leonhard
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Frommlet, Floria ...
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Segelcke, Daniel
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Pogatzki-Zahn, E ...
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Voelkl, Bernhard
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Friede, Tim
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Brunner, Edgar
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Dempfle, Astrid
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Haller, Bernhard
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Jung, Marie Juli ...
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Riecken, Lars Bj ...
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Kuhn, Hans-Georg
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Tenbusch, Matthi ...
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Higuita, Lina Ma ...
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Remarque, Edmond ...
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Grüninger-Egli, ...
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Manske, Katrin
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Kobold, Sebastia ...
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Rivalan, Marion
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Wedekind, Lisa
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Wilcke, Juliane ...
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Boulesteix, Anne ...
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Meinhardt, Marcu ...
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Spanagel, Rainer
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Hettmer, Simone
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von Lüttichau, I ...
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Regina, Carla
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Dirnagl, Ulrich
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Toelch, Ulf
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show less...
- About the subject
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- SOCIAL SCIENCES
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SOCIAL SCIENCES
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and Psychology
- Articles in the publication
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Translational Me ...
- By the university
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Stockholm University