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Mark Pletcher provides a commentary on the Toerper article and asserts that the methods represent a critically important step toward a functional learning health system. UCSF Epidemiology & Biostatistics UCSF School of Medicine SCTorg

Shrikant Bangdiwala and Salim Yusuf offer a new, pragmatic approach to conducting interim analyses of randomized clinical trials. SCTorg McMaster University McMaster University Department of Medicine #clinicaltrials

Caroline Mead-Harvey et al. provide evidence that in reporting toxicities the full set of PRO-CTCAE attributes should be administered for each adverse event and that summary scores be reported. @biostatgrl Gina Mazza Ethan Basch SCTorg

A study highlighting the state of #IPD sharing for top revenue-generating medicines shows 64% eligibility, but ongoing trials lag. Natansh Modi et al advocate for standardized policies & external platforms to enhance data access. #ClinicalTrials #DataSharing SCTorg Flinders University

Retrospective analysis by Walter Nelson et al of 77K patients from 7 clinical trials shows that machine learning may hold promise for augmenting centralized statistical monitoring. PHRI.ca Population Health Research Institute 🇨🇦 Hamilton Health Sciences SCTorg McMaster University #clinicaltrials

Concerned that mid-stream design changes can disrupt the validity of clinical trials? Sudeshna Paul and colleagues examine the impact of major design changes in a dementia trial using simulations. Emory University Emory Nursing Emory Office of Nursing Research Sudeshna Paul, PhD SCTorg #clinicaltrials

Charles Swanton and colleagues show that enrolment approaches used in the NHS-Galleri trial enabled rapid recruitment of an older, socioeconomically diverse participant population. GRAIL Charles Swanton Peter Sasieni SCTorg

What to do when a clinical trial terminates prematurely? Less than half of protocols for paediatric clinical trials in the UK contain guidance for healthcare professionals on how to manage participants, says Helen Pluess-Hall. Helen Pluess-Hall University of Bath @UHBW Julie Menzies SCTorg

Sharing aggregate results from pragmatic clinical trials presents ethical & logistical considerations that are distinct from conventional clinical trials, argues Stephanie Morain and colleagues. Stephanie Morain NIH Pragmatic Trials Collaboratory SCTorg #clinicaltrials

Ever conducted an N of 1 trial and wondered about when the evidence is sufficiently convincing to stop? Subodh Selukar and colleagues examine the statistical issues and provide a framework for sequential monitoring. @stjude UW Biostatistics @CembOxford SCTorg

Michael Martens and colleagues examine early stopping rules for toxicity in randomized trials, contrasting different alpha spending strategies, and providing software for potential users. nhlbi NIH NHLBI SCTorg Medical College of Wisconsin #BMTCTN #MedicalCollege

Ever wondered if investigators requesting clinical trials data for secondary analyses actually follow the proposals they used to justify access to the data? The Yale Open Access group examine this question. Joshua D. Wallach Joseph Ross Harlan Krumholz SCTorg Open Access Data Centres

Estimation of a counterfactual placebo event rate in an active control study is technically challenging. Sheila Kanslime and colleagues examine these challenges in the context of a PrEP HIV trial with a pre-registration cohort. MRC/UVRI and LSHTM Uganda Research Unit PrEPVacc SCTorg #clinicaltrials

Kanako Fuyama and colleagues examine the impact on statistical power of correlations between outcomes in clinical trials with multiple primary outcomes, composite endpoints or prioritized outcomes. Hokkaido University SCTorg #GPC #CompositeOutcomes #MultipleTesting #ClinicalTrials

Nathaniel Williams et al describe experiences with a multi-level approach to recruitment and retention in an implementation clinical trial, involving organizational leaders, clinicians, staff and patients. Rinad Beidas, PhD #implementationscience SCTorg Boise State University Northwestern Feinberg School of Medicine

Maciej Fronc and colleagues review technical approaches to central statistical monitoring of data quality in clinical trials, offering ideas for future directions. SCTorg #FDA #EMA #ClinicalTrials #CSM #CM #RBM #RBQM

A team from the FDA provide a comprehensive review of drug approvals for non-oncologic rare diseases over a 10-year period, characterizing study design features and primary endpoints used. FDA #FDA SCTorg #clinicaltrials

Anna Moseley and colleagues examine the topic of stratification in small randomized trials, concluding that it is inadvisable to use many stratification factors. SCTorg National Cancer Institute #clinicaltrials

Cancer clinical trials typically include only patients with good performance status. But what’s the impact on people who are disabled at the outset? Nicole Agaronnik and colleagues investigate. SCTorg FDA #FDA National Cancer Institute Nicole Agaronnik

Umar Niazi and colleagues show how to share and analyze clinical trial & translational data with ease. #clinicaltrials #openaccess #datascience #healthcare Southampton CTU SCTorg