@colinbbegg.bsky.social
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
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
January 6, 2026 at 3:00 PM
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
January 6, 2026 at 2:53 PM
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
January 6, 2026 at 2:37 PM
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. [email protected]
January 6, 2026 at 1:58 PM
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. [email protected]
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
January 5, 2026 at 8:42 PM
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
January 5, 2026 at 6:59 PM
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
January 5, 2026 at 6:47 PM
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
January 5, 2026 at 6:18 PM
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.
January 5, 2026 at 6:02 PM
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
January 5, 2026 at 5:51 PM
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
January 5, 2026 at 5:35 PM
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
October 23, 2025 at 5:04 PM
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
October 23, 2025 at 4:52 PM
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
October 23, 2025 at 4:35 PM
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
October 23, 2025 at 3:42 PM
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
October 23, 2025 at 3:21 PM
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
October 23, 2025 at 3:07 PM
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
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
October 23, 2025 at 2:46 PM
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
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
October 23, 2025 at 2:31 PM
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
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
October 23, 2025 at 2:16 PM
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
How good are GenAI algorithms at writing clinical trial documents? Nigel Markey and colleagues show how to set up GenAI algorithms successfully.
August 1, 2025 at 7:14 PM
How good are GenAI algorithms at writing clinical trial documents? Nigel Markey and colleagues show how to set up GenAI algorithms successfully.
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.
August 1, 2025 at 6:48 PM
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.
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
August 1, 2025 at 6:02 PM
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