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In New Book, History Ph.D.s Explore 'Why We Can't Quit American Girl'

Mary Mahoney and Allison Horrocks talk the enduring significance of American Girl -- and why Molly would get kicked out of UConn

Rhode-island , United-states , Williamsburg , New-york , New-yorker , American , Allison-horrocks , Ingrid-hess , Mary-mahoney , Julie-albright , Helder-mira , Pleasant-rowland

Reporting of Factorial Randomized Trials

This article provides an extension of the Consolidated Standards of Reporting Trials 2010 checklist for the reporting of factorial trials.

London , City-of , United-kingdom , Brennanc-kahan , Clinical-trials-unit-at-university-college-london , Research-council , United-kingdom-office-for-national-statistics , United-kingdom-national-institute-for-health , National-institute-of-health-research , Better-research , Care-research

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 greater clarity, reproducibility, informativeness, and usefulness of results.

Early phase dose-finding (EPDF) or dose escalation or de-escalation trials, commonly known as phase 1 or phase 1 or 2 trials, are an integral part of clinical development. EPDF trials typically evaluate new interventions that can be given in different doses and can be pharmacological (chemical or biological—eg, drugs, vaccines, cell therapies, gene therapies), non-pharmacological (eg, radiotherapy, rehabilitation, devices, digital therapies), or a combination of both. These trials require interim decisions on dosing changes of an intervention and generate data on safety and other information such as pharmacokinetics, pharmacodynamics, biomarker, or clinical activity to guide dosing selection and future clinical development.1234 In this article, a broad definition of “dose” is applied, because terms such as “dose finding,” “dose escalation,” “dose de-escalation,” “dose expansion,” and “dose level” are widely used. Here, dose might refer not only to the amount but also to the frequency, intensity, or duration of an intervention.5 The term could therefore be regarded as synonymous and used interchangeably …

Canada , Australia , Glasgow , Glasgow-city , United-kingdom , West-midlands , United-kingdom-general- , Maastricht , Limburg , Netherlands , United-states , Scotland

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 stages where decisions are based on balance of benefits and risks or harms of the intervention under investigation. Lack of efficacy or evidence of harm due to adverse safety profiles are common reasons for phase 2 and phase 3 trials to be unsuccessful.12 Phase 3 trial failures can reflect incorrect decisions made at earlier stages, including in early phase dose-finding (EPDF) trials (commonly known as phase 1, phase 1/2, or first-in-human trials). Reasons why interventions do not progress or succeed in later stages of clinical development include misleading preclinical studies, inadequate participant selection, inefficient trial design, suboptimal biomarker or outcome choices, and poor dose selection. The same reasons can also contribute to early discontinuation of promising interventions.

EPDF trials typically evaluate new interventions that can be used in different doses and can be pharmacological (chemical or biological—eg, drugs, vaccines, cell therapies, gene therapies), non-pharmacological (eg, radiotherapy, devices, rehabilitation, digital therapies), or a combination of both. They usually include a small number of …

Canada , Glasgow , Glasgow-city , United-kingdom , Australia , Maastricht , Limburg , Netherlands , West-midlands , United-kingdom-general- , United-states , Canadian

Hannity

value system that contradicts layers and crt, et cetera. >> i couldn't agree with you more. the answer to this humiliation we are suffering in the inner city schools is choice. vouchers, charters, school choice. i'm glad you raised this. this ties in directly with one of the most important themes in the supreme court opinion today. i talk about it in the book, the politically incorrect guide to the court. this court does not trust bureaucrats and experts anymore. 25 years ago they took the educators word for it that affirmative action, racial preferences was a good thing. that racial diversity was necessary for better teaching, for better research. today the court says we defer no longer. chief justice roberts says quite clearly we are not going to take your word for it anymore teachers and administrators. judges refuse common sense to review and demand. is there any proof that racial

Schools , Choice , Value-system , School-choice , Charters , Answer , Layers , Crt , Humiliation , Vouchers , Inner-city , Et-cetera

Hannity

it's there, crt, etc.. >> i couldn't agree with you more. and the answer to this humiliat swer to e and we're suffering in our inner city schools is choice vouchers, charters,gly school choice. but i'm glad you raised us because this ties iou rn ones the most important themes in the supreme court opinion toda i . i also talk about it in t the book. you just mention this politically incorrect guidhe boe to the court, which is this court does not trust bureaucrat cs and expertsanymor anymore. e.25 years ago, they took the educators word for it that affirmative action for, racial preferences was a good thing, that racial diversity wangs necessary for better teaching, for better research. nenow, today, the court says we defer no longer. in fact, chief justice roberts says quite clearly, we're not going to tak ge your word for it anymore. >> teachers and administrators, judges are and a to use common e to review and demand. >> is there anreview ay that ral

Schools , Charters , Answer , Choice-vouchers , Humiliat-swer-to-e , Inner-city , Gly-school-choice , Etc , Crt , It , Book , Court

10 new AI tools to boost productivity

10 new AI tools to boost productivity
techstory.in - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from techstory.in Daily Mail and Mail on Sunday newspapers.

Linkedin , Youtube , Better-research , Google , Smart-compose , Google-chrome , Microsoft-edge , Resume-checker , Personal-website , Resume-examples , Google-docs

Intellectual property, commercialization topic of next Building Better Research webinar

Intellectual property, commercialization topic of next Building Better Research webinar - The Brock News, a news source for Brock University

Bradley-mclean , Iva-bruhova , Brock-university-library , Upcoming-building-better-research , Building-better-research , Office-of-research-services , Business-development , Research-service-partnerships , Intellectual-property-advancement , Associate-director , Business-development-officer , Better-research

Driving with ADHD: Pumping the Brakes on Vehicle Safety Risks

ADHD and driving are a potentially dangerous combination with clinical and public health implications. Read the research on vehicle-related risks and safety strategies for teens and adults with ADD.

United-states , Liechtenstein , Massachusetts-institute-of-technology , Massachusetts , Lichtenstein , America , Joseph-biederman , Lisdexamfetamine-dimesylate , Better-research , Journal-of-safety-research , Journal-of-psychiatric-research , Behavior-research-methods

TVP doliczy reklamodawcom widownię poza domem, TVN Media tego nie zrobi. „Telewizja traci wiarygodność"

TVP doliczy reklamodawcom widownię poza domem, TVN Media tego nie zrobi. „Telewizja traci wiarygodność"
wirtualnemedia.pl - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wirtualnemedia.pl Daily Mail and Mail on Sunday newspapers.

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