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Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose-finding trial protocols. It is envisioned that the resulting improvements in the design and conduct of early phase clinical trials will ultimately reduce research inefficiencies and inconsistencies, driving transformational advances in clinical care.

Developing an intervention is a lengthy process purs ....

Glasgow City , United Kingdom , West Midlands , United Kingdom General , United States , Daiichi Sankyo , Oxford Biotherapeutics , Janssen Clovis , Lilly Incyte , Smith Kline , Celgene Eisai , Sumitomo Dainippon Pharma , Genentech Roche , Astra Zeneca , Merck Serono , Canadian Arthritis Patient Alliance , Outcomes Research Institute , Vertex Pharmaceuticals , Gilead Sciences , European Commission , Birmingham Health Partners Centre For Regulatory Science , Research Future Fund , United Kingdom Health Research Authority , Health Canada , Microbiology Research Centre , Bayer Ag ,

The malaria species rampant in the Asia-Pacific region has been a significant driver of evolution of the human genome, a new study has shown.

'Benign' Malaria Key Driver of Human Evolution in Asia-Pacific ScienceDaily (Sep. 4, 2012) Professor Ivo Mueller led a study that showed the malaria species rampant in the Asia-Pacific region has been a significant driver of evolution of the human genome An international team of researchers has shown that Plasmodium vivax malaria, the most prevalent malaria… ....

Papua New Guinea , United States , Sciencedaily Sep , Ivo Mueller , Barcelona Centre For International Health Research , Eliza Hall Institute , National Health , Centre Of Global Health , National Institutes Of Health , Papua New Guinea Institute Of Medical Research , Malariagen Consortium , University Of Western Australia , Research Council Of Australia , Benign Malaria Key Driver , Human Evolution , Barcelona Centre , International Health Research , Papua New Guinea Institute , Medical Research , Global Health , Southeast Asian , South West Pacific , Professor Mueller , Medical Research Council , National Institutes , United States Department ,

Anxiety, Depression May Ease After Ablation Cuts AF Burden

One can t say there is no placebo effect from AF ablation, but if there is, it s probably not the main driver of psychological benefit, say researchers. ....

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Machine Learning Aids in Event Prediction

Machine Learning Aids in Event Prediction
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Alex Gruen , Anne Louise Ponsonby , National Health , Department Of Industry , Slowvoice Pty Ltd , Generation Social Science Program , Research Council Of Australia , Professor Anne Louise Ponsonby , Next Generation Social Science , Area Under , Slowvoice Pty , Medical Research Council ,

Stratification of enterochromaffin cells by single-cell expression analysis

Stratification of enterochromaffin cells by single-cell expression analysis
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New South Wales , United States , Jesus Olvera , Sct Cartpt Trpm , Mechanosensor Piezo , Perkin Elmer , Elsa Molina , Ardem Patapoutian , National Research Service Award , University Of Melbourne Animal Experimentation Ethics Committee , University Of Melbourne , Electron Microscopy Sciences , Collagenase Iv Worthington Biochemical Corporation , Institute For Genomic Medicine , Thermo Fisher , Research Council Of Australia , U Dnasei Worthington Biochemical Corporation , National Health , Takeda Sanford Innovation Alliance , University Of California San Diego , Supplementary Fig , Supplementary Table , California San Diego , Institutional Animal Care , Medical Research Council , Melbourne Animal Experimentation Ethics ,