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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 statesUnited kingdomThomas wicksUnited kingdom health research authorityChina drug authorityCompliance rulesEconomic 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 cityUnited kingdomWest midlandsUnited kingdom generalUnited statesDaiichi sankyoJanssen clovisOxford biotherapeuticsLilly incyteCelgene eisaiSumitomo dainippon pharmaGenentech rocheBristol myers squibbAstra zenecaMerck seronoSanofi aventis

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 pursued in

Glasgow cityUnited kingdomWest midlandsUnited kingdom generalUnited statesDaiichi sankyoOxford biotherapeuticsJanssen clovisLilly incyteSmith klineCelgene eisaiSumitomo dainippon pharmaGenentech rocheAstra zenecaMerck seronoCanadian arthritis patient alliance

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.

City ofUnited kingdomAlexandraf santosUnited kingdom health research authorityDepartment of womenChildren health pediatric allergyResearch ethics committeeKing college london alexandraf santosCollege londonPediatric allergyCollege london schoolLife course sciencesResearch ethicsAllergy clinBaked eggBasophil 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 statesUnited kingdomNorth yorkshireCity ofOnderzoek uz ku leuvenTechnische universitEzio bonifacioInstitute of diabetes researchDresden university of technologyIslet autoantibody standardization programGraphpad softwareDiabetes research foundationNovonordisk united kingdom research foundationDiabetes researchUnited kingdom health research authorityGerman center