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

Tansy Edwards and colleagues propose a method for estimating the confidence interval for the complier average effect in the context of non-compliance in a cluster randomized clinical trial. @lshtm.bsky.social

A novel method for benefit-risk analysis linking desirability of outcome ranking (DOOR) and multivariate survival outcomes is proposed by researchers from the George Washington University.

Xiaoyu Tang and colleagues propose an improved method for evaluating surrogate endpoints in a meta-analytic framework using the restricted mean survival time. @busph.bsky.social

David Dunn et al show that dramatic reductions in sample size can be achieved by using the averted events ratio rather than the conventional method based on the rate ratio for non-inferiority active-control prevention trials with a time-to-event outcome. @mrcctu.bsky.social

Over-volunteering in phase I clinical trials by healthy volunteers presents risks. Roberto Abadie and colleagues advocate the use of national registries, as implemented in France, Malaysia and the UK, to offset this problem. @hastingscenter.bsky.social @uw-medicine.bsky.social

Caregiver perspectives on clinical trials and roles in patient enrollment decisions remain understudied. This review assessed the state of current research on caregiver roles in cancer trial enrollment decision-making. @hastingscenter.bsky.social

Aitana Juan-Giner review informed consent practices in vaccine clinical trials in sub-Saharan Africa, concluding that lack of understanding can lead to confusion and suspicion. @isglobal.bsky.social ic-matters.bsky.social

Determining cause of death is crucial for studying disease free survival in clinical trials. Mark Nelson and colleagues conducted a validation study in Australia to see if the costs of adjudication panels are warranted. @utas.edu.au

Through hands-on mentorship, real-world placements, and comprehensive curriculum, the CANSTAT network aims to train a generation of biostatistics experts who will strengthen Canada's clinical trial capacity and improve health outcomes. @machealthsci.bsky.social @parpia.bsky.social

Tra My Pham and colleagues address the IHC E9 (R1) addendum on intercurrent events in clinical trials, showing how to align estimators for commonly used analytic techniques. @mrcctu.bsky.social @lshtm.bsky.social