Today, our paper updating insights into #Avandia and cardiovascular (cv) risk was published in The BMJ For this study, we wanted to: 1. Clarify cv uncertainties 2. Apply different analytical approaches 3. Understand the power of shared data 1/9 bmj.com/content/368/bm…

Gratified to see growing # of #clinicaltrials including & reporting results in pts w/ #brainmets. They’ve been excluded from #drugdevelopment for yrs b/c it was “too risky” for pts & companies. Want to include them in your trials? We detail how here: bit.ly/2OErpGT

'Patients more often reported (-) beliefs about trial enrollment compared w/ physicians/staff (e.g. trials do not help patients personally, 33% vs 2%) but less often felt they had no other options when agreeing to join (38% vs 86%).' journals.sagepub.com/doi/full/10.11…

Adult caregivers with low "intention to attend" paediatric trial requirements are no less likely to have their child complete studies than caregivers with high intention. Go figure! @SarahKeim1 journals.sagepub.com/doi/full/10.11…

Compliance avec French academic clinical trials with the Clinical Trial Facilitation and Coordination Group recommendations on contraception et pregnancy testing requirements - c'est très mauvaise! Nana 🌸 journals.sagepub.com/doi/full/10.11…

Clinical Trials journal of SCTorg is having its annual editors meeting online

Today we recognize Aisha T. Langford, PhD, MPH. Family Medicine., co-director of NYU Clinical & Translational Science Institute's Recruitment & Retention Unit, an active member of Society for Medical Decision Making (SMDM) & SBM, an assoc. editor Clinical Trials, an asst professor NYU Grossman School of Medicine, & so much more! NYU Langone Health #Juneteenth

Clinical Trials journal of SCTorg

The power of communication and collaboration: one of the lessons learned during the IMPACT-Afib trial. Read more about what the study team, including Department of Population Medicine's Richard Platt & Noelle Cocoros, found - online now in Clinical Trials SCTorg. ow.ly/i6sZ50Ao959

How might COVID19 trials be designed to kill under-performing treatments quicker? Futility hypotheses, Rx pooling, reciprocal controls, ranking & selection, and platform administration show promise, says Steve Piantadosi in Clinical Trials latest journals.sagepub.com/doi/full/10.11…

Why are non-inferiority trials disproportionately "positive" on their primary endpoint (compared w/ superiority)? New study in Clinical Trials by Nicolas A. Bamat, MD MSCE et al suggests it's not because of lower protocol adherence rates. SCTorg journals.sagepub.com/doi/full/10.11…

Is it ethical, asks @nwcarris et al, to preempt the publication of another researcher’s unpublished trial data or preliminary analysis, perhaps without citation? jme.bmj.com/content/early/…

Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration: A Cohort Study: Annals of Internal Medicine acpjournals.org/doi/pdf/10.732…

Observational Cacophony, Randomized Harmony. Weighing the Benefits and Risks of Proliferating Observational Treatment Assessments in tackling COVID-19. Viewpoint from ⁦@califf001⁩ ⁦Adrian “WE NEED RCTS!” Hernandez⁩ and me. jamanetwork.com/journals/jama/…

New article on our DURATIONS design just published in Clinical Trials. With [email protected], Max Parmar, James Carpenter, Michelle Clements MRC Clinical Trials Unit at UCL. Short introductive thread. journals.sagepub.com/doi/10.1177/17…

Cardiovascular non-inferiority trials using surrogate markers as primary endpoints: more common- and frequent problems w/ reporting, interpretation, etc. Benhood Bikdeli, Harlan Krumholz et al journals.sagepub.com/doi/full/10.11…

The disharmony of #Coronavirus #COVID19 disease ordinal scales, from Deborah Zarin & Stephen Rosenfeld, SCTorg journals.sagepub.com/doi/full/10.11…

How good is risk–benefit language in #informedconsent documents for early phase #clinicaltrials? Sehr schlect, according to this analysis empirical from Hannes Kahrass Daniel Strech et al SCTorg journals.sagepub.com/doi/full/10.11…

An algorithm for converting National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a single composite numerical grade, from Ethan Basch et al journals.sagepub.com/doi/full/10.11…

Pre-statistical harmonization of data structure, variables, and codebooks facilitates 2° analysis of #RCTs. Here, Ryoko Susukida et al describe a data harmonization initiative for substance use disorder treatment #RCTs @EvanMayoWilson NIDAnews SCTorg journals.sagepub.com/doi/full/10.11…