Colin Begg

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 @MedicalCollege #BMTCTN #MedicalCollege

Kamil Malshy and colleagues recount the long and influential history of the military in clinical trials, all the way from King Nebucchadnezzar, through James Lind with the British navy, to recent wars in Iraq and Afghanistan. @SCTorg @WestPoint_USMA @USArmy @BritishNavy

Using data from the ACTT COVID trial Bonnett, Potter and Dodd simulate the impact on type 1 error of using non-concurrent controls in platform trials with secular trends in outcome. @SCTorg @NIAIDNews @BerryConsultant #FDA

Cleland and Anzar provide a highly critical commentary on the Wittes et al. article. @FloridaAtlantic @SCTorg @uw_medicine @ASCAP_QMUL @UofGlasgow

A group of experts led by Janet Wittes revisit the influential ASPREE clinical trial, strongly criticizing how it was reported and its influence on guidelines for use of aspirin in disease prevention. @FloridaAtlantic @SCTorg @uw_medicine @ASCAP_QMUL

Check out the articles from the 16th Annual Conference on Clinical Trials hosted by the University of Pennsylvania, edited by Mary Putt and Pamela Shaw. The focus is on dose selection. @SCTorg @UPennDBEI #FDA #clinicaltrials

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

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 @theNCI @agaronnik45485

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

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

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

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. @Rsbeidas #implementationscience @SCTorg @BoiseState @NUFeinbergMed

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. @HokkaidoUni @SCTorg #GPC #CompositeOutcomes #MultipleTesting #ClinicalTrials

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_Uganda @PrEPVacc @SCTorg #clinicaltrials

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. @JoshuaDWallach @jsross119 @hmkyale @SCTorg @OADC_Official

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 @UWBiostat @CembOxford @SCTorg

Sharing aggregate results from pragmatic clinical trials presents ethical & logistical considerations that are distinct from conventional clinical trials, argues Stephanie Morain and colleagues. @smorain @Collaboratory1 @SCTorg #clinicaltrials

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. @HellsPH @UniofBath @UHBW @jmenzies1 @SCTorg

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

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. @EmoryUniversity @EmoryNursing @EmoryONR @sudeshnapaul @SCTorg #clinicaltrials