Additional crossovers in cluster randomized crossover trials DO NOT always increase statistical power! This paper describes when additional crossovers don't provide any additional benefit. @jesskasza.bsky.social

Spencer Cho and colleagues examine the evolving role of the placebo in non-inferiority trials as an alternative to an existing, unproven treatment. They highlight common methodological gaps and call for greater transparency in future trials. #clinicaltrials

Is multiple imputation more powerful than complete case analysis in clinical trials? A systematic review by Thomas Sullivan found multiple imputation often led to noticeable changes in the effect estimate but did not demonstrate consistent precision advantages. #ClinicalTrials

RECOVER-VITAL uses a flexible, patient-informed platform to test potential therapies for #LongCOVID symptoms. With biomarker collection and adaptive design, it’s a blueprint for smarter, faster research. @dcrinews.bsky.social @duke-university.bsky.social

Researchers from @mrcctu.bsky.social explored how #Bayesian methods are used in confirmatory #ClinicalTrials. The most common reasons for choosing Bayesian methods were making probability statements about the interventions evaluated or flexibility in adapting the trial design.

Dixon Orlando and colleagues examine the validity of competing methods for analyzing stepped wedge trials with batches. #clinicaltrials @monashuniversity.bsky.social @jesskasza.bsk.social

Do you believe patients actually read informed consent forms? Zeke Emanuel and colleagues have conducted a study of reading comprehension. @ZekeEmanuel.bsky.social @PennMedicine.bsky.social @BMSNews.bsky.social

According to Rogier Landman and colleagues from Pfizer generative AI is reshaping statistical analysis plan authoring, turning weeks into minutes, standardizing content, and speeding trial evidence so therapies reach patients sooner. #AI #ClinicalTrials @Pfizer

Yousra Kherabi and colleagues examine the challenges of implementing response adaptive randomization in the context using an intermediate endpoint when long follow-up is required for the true endpoint. @yousrakherabi.bsky.social @niaidnews.bsk.social

Post-market studies supporting recently approved FDA drugs are increasingly using non-randomized RWE approaches, note Louis Li and colleagues, though such approached remain infrequent in the pre-market setting. @JoshuaDWallach @yalesph.bsky.social @reshmagar.bsky.social @jsross119.bsky.social

Stephen Joffe and colleagues conducted a study of the perception of various stakeholder groups of the role of the PI in a clinical trial, highlighting differences with regard to publicly-funded versus industry trials. @stevejoffe.bsky.social @pennmehp,bsky.social @carygross.bsky.social

Kylie Lange and colleagues outline a sample size calculator for clinical trials in which some participants are independent and others are clustered, such as multiple births. @klange-au.bsky.social @sahmri.bsky.social @austrim-cre.bsky.social

In randomized trials where some patients crossover, RPSFT models permit estimation of the survival effect. Pedro Torres-Saavedra et al demonstrate that this estimator exhibits unusual behavior with long-tailed distributions.

Dongquan Bi et al examine recently published cluster randomized trials, finding low uptake of estimands, highlighting urgent need to develop guidelines for unique aspects of cluster trials to ensure clarity of research questions. dqb1.bsky.social brennankahan.bsky.social @mrcctu.bsky.social

Kim Boesen and colleagues examined publicly available, routinely updated clinical trial databases to assess their capacities for supporting systematic reviews, noting that individual participant data are still largely unavailable. @unibas.ch

New systematic review clarifies the distinct roles of Clinical Study Coordinators and Data Managers in clinical trials. Standardized training & collaboration are key to improving trial quality & efficiency.

Daniel Karel and David Wendler provide a commentary on the article by Wimsett et al. @aucklanduni.bsky.social @research-ethics.bsky.social

Is it possible to recruit ethically for intrapartum clinical trials? Jordon Wimsett and colleagues found that a 2-stage consent process (brief intrapartum + full postpartum) was acceptable to most patients & clinicians. @aucklanduni.bsky.social @research-ethics.bsky.social

Erica Brittain and colleagues use theoretical arguments concerning stability to justify the use of anticipated events rather than total sample size in planning clinical trials. @niaidnews.bsky.social

Jessica Roydhouse and colleagues examine the GP5 item on the FACIT tool to measure the overall side effect impact in oncology clinical trials, providing evidence of its validity. @ethanbasch.bsky.social @menziesresearch.bsk.social

Robert Lee and colleagues have developed an NLP tool to identify goals of care discussions from the medical record as outcomes from pragmatic clinical trials, demonstrating high sensitivity. @BobLeeMD.bsky.social @uwmedicine.bsky.social

Erin Chase and colleagues report on a suicide risk management protocol designed to facilitate the inclusion of people experiencing suicidal behavior into clinical trials of mental health, a typically excluded group. #clinicaltrials

Lisa Eckstein and colleagues have examined Data Monitoring Committee charters for clinical trials, and find considerable variability with regard to data availability, external communication, post-trial responsibilities and conflict resolution. @nufeinbergmed.bsky.social @lisaeckstein.bsky.social

Fiona Kennedy & colleagues report a study showing that remote electronic PRO-AE reporting by patients enrolled on early phase trials is feasible and acceptable. Self-reported PROs captured a broader range of symptoms. @drfionarkennedy.bsky.social @universityofleeds.bsky.social

Carla Godoy and colleagues examined recent FDA approvals based on a single pivotal trial, finding that only 20% had referenced confirmatory evidence, though this proportion increased markedly after 2019 FDA guidance. @yaleschoolofmed.bsky.social @jsross119.bsky.social

Kelly Boone and colleagues examined factors associated with participation in a clinical trial in toddlers, identifying marriage, white race and late gestational age as negative predictors. @nationwidekids.bsky.social

Isaac Egesa and colleagues review published trials that employed multiple randomizations in a SMART design. They found that most had 2 randomizations and there is inconsistent reporting of key methodological features. liverpooluni@bsky.social

Should participants enrolled in pragmatic clinical trials without consent be notified? A complex decision that is context-specific, according to Stephanie Morain and colleagues. #pragmatictrial @stephaniemorain.bsky.social @bermaninstitute.bsky.social

Mild-to-moderate depressive symptoms, below the threshold for diagnosing a depressive disorder, are associated with negative self-reporting of symptoms in clinical trials, report Christine Girges and colleagues. @uclh.bsky.social

Nicholas Pieper and colleagues used a national survey to examine clinical trial knowledge as a function of use of digital health technology, providing pointers to increased clinical trial participation. @universityoflou.bsky.social