Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies
Objectives Designing studies with an internal pilot phase may optimise the use of pilot work
to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed …
to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed …
Adaptive design clinical trials: a review of the literature and ClinicalTrials. gov
Objectives This review investigates characteristics of implemented adaptive design clinical
trials and provides examples of regulatory experience with such trials. Design Review of …
trials and provides examples of regulatory experience with such trials. Design Review of …
[HTML][HTML] Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update
Background The Medical Research Council published the second edition of its framework in
2006 on developing and evaluating complex interventions. Since then, there have been …
2006 on developing and evaluating complex interventions. Since then, there have been …
Optimization of behavioral, biobehavioral, and biomedical interventions
LM Collins, KC Kugler - Cham: Springer International Publishing, 2018 - Springer
In the United States and worldwide, billions of dollars have been spent to develop
behavioral, biobehavioral, and biomedical interventions (hereafter referred to simply as …
behavioral, biobehavioral, and biomedical interventions (hereafter referred to simply as …
The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de‐risk trial programmes of novel agents
Despite considerable progress in pharmacotherapy over the past seven decades, many
mental disorders remain insufficiently treated. This situation is in part due to the limited …
mental disorders remain insufficiently treated. This situation is in part due to the limited …
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
High quality protocols facilitate proper conduct, reporting, and external review of clinical
trials. However, the completeness of trial protocols is often inadequate. To help improve the …
trials. However, the completeness of trial protocols is often inadequate. To help improve the …
The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an …
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without
compromising the validity of conclusions and it is essential to distinguish pre-planned from …
compromising the validity of conclusions and it is essential to distinguish pre-planned from …
New author guidelines for displaying data and reporting data analysis and statistical methods in experimental biology
MC Michel, TJ Murphy, HJ Motulsky - Journal of Pharmacology and …, 2020 - ASPET
The American Society for Pharmacology and Experimental Therapeutics has revised the
Instructions to Authors for Drug Metabolism and Disposition, Journal of Pharmacology and …
Instructions to Authors for Drug Metabolism and Disposition, Journal of Pharmacology and …
Common misconceptions about data analysis and statistics
HJ Motulsky - Journal of Pharmacology and Experimental …, 2014 - ASPET
Ideally, any experienced investigator with the right tools should be able to reproduce a
finding published in a peer-reviewed biomedical science journal. In fact, however, the …
finding published in a peer-reviewed biomedical science journal. In fact, however, the …
Strategies to improve drug development for sepsis
MP Fink, HS Warren - Nature reviews Drug discovery, 2014 - nature.com
Sepsis, a common and potentially fatal systemic illness, is triggered by microbial infection
and often leads to impaired function of the lungs, kidneys or other vital organs. Since the …
and often leads to impaired function of the lungs, kidneys or other vital organs. Since the …