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Beyond Compliance: Operationalizing Disclosure Intelligence For Compliance At Scale

Beyond Compliance: Operationalizing Disclosure Intelligence For Compliance At Scale
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United States , United Kingdom , Thomas Wicks , United Kingdom Health Research Authority , China Drug Authority , Compliance Rules , Economic Area ,

Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote gr ....

Glasgow City , United Kingdom , West Midlands , United Kingdom General , United States , Daiichi Sankyo , Janssen Clovis , Oxford Biotherapeutics , Lilly Incyte , Celgene Eisai , Sumitomo Dainippon Pharma , Genentech Roche , Bristol Myers Squibb , Astra Zeneca , Merck Serono , Sanofi Aventis , Cancer Research United Kingdom , International Delphi , United Kingdom Medical Research Council , United Kingdom Research , European Federation Of Pharmaceutical Industries , University Of Maastricht , University Of Birmingham , Takeda Pharmaceuticals , Imperial Biomedical Research Centre , Royal Marsden Institute Of Cancer Research ,

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 ,

Basophil Activation Test Most Effective for Prediction of Severity, Allergic Reaction Threshold to Egg

This research shows that a basophil activation test can support decision-making by clinicians when re-introduction of baked eggs in patients with allergies is a treatment being considered.
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City Of , United Kingdom , Alexandraf Santos , United Kingdom Health Research Authority , Department Of Women , Children Health Pediatric Allergy , Research Ethics Committee , King College London Alexandraf Santos , College London , Pediatric Allergy , College London School , Life Course Sciences , Research Ethics , Allergy Clin , Baked Egg , Basophil Activation ,

SARS-CoV-2 Infection and Development of Islet Autoimmunity in Early Childhood | Infectious Diseases | JAMA

This longitudinal study of young children in 5 European countries investigates whether there is a temporal association between SARS-CoV-2 infection and islet au ....

United States , United Kingdom , North Yorkshire , City Of , Onderzoek Uz Ku Leuven , Technische Universit , Ezio Bonifacio , Institute Of Diabetes Research , Dresden University Of Technology , Islet Autoantibody Standardization Program , Graphpad Software , Diabetes Research Foundation , Novonordisk United Kingdom Research Foundation , Diabetes Research , United Kingdom Health Research Authority , German Center , Harryb Helmsley Charitable , Python Software Foundation , University Of Bristol , Group Information , University Of Warsaw , Participantsbetween February , Primary Oral Insulin Trial , Global Platform , Autoimmune Diabetes , Medical University ,