iiinova — where your digital self keeps evolving

colinbbegg.bsky.social @colinbbegg.bsky.social · 31/08/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 31/08/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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.

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 02/07/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/04/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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.

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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.

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 26/02/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 06/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 06/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 06/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 06/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 06/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 05/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 05/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 05/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 05/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 05/01/2026

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.

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colinbbegg.bsky.social @colinbbegg.bsky.social · 05/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 05/01/2026

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

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

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

Susan Halabi and colleagues advocate a Bayesian study design for integrating data from multiple basket trials for studying rare cancers. @duke-university.bsky.social @DukeMedSchool.bsky.social

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

Aryelly Rodriguez and colleagues have studied publicly available de-identified clinical trial datasets and have evaluated the risks of identification of individuals via a risk score. @edinburgh-uni.bsky.social

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colinbbegg.bsky.social @colinbbegg.bsky.social · 23/10/2025

Clare Bailey and colleagues document the time savings for clinical research staff due to automatic retrieval of data from the electronic medical records in the VOYAGER clinical trial. @bristoluni.bsky.social

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colinbbegg.bsky.social @colinbbegg.bsky.social · 01/08/2025

How good are GenAI algorithms at writing clinical trial documents? Nigel Markey and colleagues show how to set up GenAI algorithms successfully.

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colinbbegg.bsky.social @colinbbegg.bsky.social · 01/08/2025

A study by Maryam Mooghali and colleagues at the Yale CRRIT found that the CMS Coverage with Evidence Development program has successfully prompted generation of more robustly designed clinical studies to better inform clinical, regulatory, and coverage decisions.

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colinbbegg.bsky.social @colinbbegg.bsky.social · 01/08/2025

It’s time we had discipline-specific education to create a job-ready clinical trial workforce with professional recognition. Simone Spark and colleagues outline an education and accreditation strategy for current and future clinical trialists. @monashuniversity.bsky.social

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colinbbegg.bsky.social @colinbbegg.bsky.social · 01/08/2025

Research conducted by Laura Doherty and colleagues at the York Trials Unit suggests that sending participant SMS reminders may positively impact participant retention in clinical trials.

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