@colinbbegg.bsky.social
Maximilian Siebert and colleagues investigated the strength of evidence supporting EMA drug approvals, finding 78% supported by RCTs but over 50% supported only by surrogate endpoints. @stanforduniversity.bsky.socia @fda.gov @jsross119.bsky.social @yalesph.bsky.social
August 31, 2026 at 6:05 PM
Maximilian Siebert and colleagues investigated the strength of evidence supporting EMA drug approvals, finding 78% supported by RCTs but over 50% supported only by surrogate endpoints. @stanforduniversity.bsky.socia @fda.gov @jsross119.bsky.social @yalesph.bsky.social
Stef Baas and colleagues argue that ethics must take a central stage when deciding whether to select a fixed or an adaptive design for a randomized clinical trial. Commentaries provided by Janet Wittes and Stephen Senn. @mrc-bsu.bsky.social @cancerethicsdoc.bsky.social @stephensenn.bsky.social
August 31, 2026 at 5:35 PM
Stef Baas and colleagues argue that ethics must take a central stage when deciding whether to select a fixed or an adaptive design for a randomized clinical trial. Commentaries provided by Janet Wittes and Stephen Senn. @mrc-bsu.bsky.social @cancerethicsdoc.bsky.social @stephensenn.bsky.social
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
July 2, 2026 at 5:41 PM
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
July 2, 2026 at 5:32 PM
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
July 2, 2026 at 5:20 PM
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
July 2, 2026 at 4:56 PM
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.
July 2, 2026 at 4:43 PM
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
July 2, 2026 at 4:37 PM
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
July 2, 2026 at 3:15 PM
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
July 2, 2026 at 3:03 PM
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
July 2, 2026 at 2:50 PM
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
July 2, 2026 at 2:42 PM
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
April 23, 2026 at 3:39 PM
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
@klange-au.bsky.social @sahmri.bsky.social @austrim-cre.bsky.social
February 26, 2026 at 8:27 PM
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
@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.
February 26, 2026 at 8:13 PM
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
February 26, 2026 at 6:50 PM
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
February 26, 2026 at 6:41 PM
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.
February 26, 2026 at 4:48 PM
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
February 26, 2026 at 4:06 PM
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
February 26, 2026 at 3:56 PM
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
February 26, 2026 at 3:28 PM
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
February 26, 2026 at 3:16 PM
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
February 26, 2026 at 2:55 PM
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
February 26, 2026 at 2:50 PM
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
January 6, 2026 at 5:23 PM
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