@TeneilleBrown Here's a paper coauthored by @HMKYale, who has a named chair at Yale. "Size effects seen in post approval clinical trials aren't reproduced in post approval trials" Sounds pretty insidious. Pharma cos are making up data! https://t.co/4Uko
RT @JoshuaDWallach: Inspired by (and working with) @OrianaCiani, we tried to compare the effect estimates from pivotal trials (trials used…
RT @JoshuaDWallach: Inspired by (and working with) @OrianaCiani, we tried to compare the effect estimates from pivotal trials (trials used…
Inspired by (and working with) @OrianaCiani, we tried to compare the effect estimates from pivotal trials (trials used to inform the approval of new drugs) on the basis of surrogate markers of disease and postapproval trials. https://t.co/KPFhgSU5oG @BMCM
The basic idea of Ratio of ORs and difference of SMD to compare results of pivotal trial and matched post-approval trials. Pivotal trials supporting FDA approval by surrogate markers of disease are often larger than the treatment effects observed among pos
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study https://t.co/6oOl4a358w
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
RT @KristinSainani: @StanfordEpiNews New meta-research by Stanford epi PhD grad Joshua Wallach @JoshuaDWallach in BMC Medicine: Comparison…
@StanfordEpiNews New meta-research by Stanford epi PhD grad Joshua Wallach @JoshuaDWallach in BMC Medicine: Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by th... https://t.co/V4bQiTfhDK
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study https://t.co/mBnON9NmPX
RT @OrianaCiani: Studi post-marketing difficilmente comparabili con quelli registrativi @US_FDA soprattutto in termini di endpoints. Il nos…
RT @jsross119: Findings from @MayoProceedings article echo work our group recently published in @BioMedCentral focused on trials supportin…
RT @jsross119: Findings from @MayoProceedings article echo work our group recently published in @BioMedCentral focused on trials supportin…
Findings from @MayoProceedings article echo work our group recently published in @BioMedCentral focused on trials supporting FDA approval of new drugs @JoshuaDWallach @OrianaCiani https://t.co/LRkni75OUa
RT @mdimairo: EMA adaptive pathway approach states "confirming the benefit-risk balance of a product, following a conditional approval base…
EMA adaptive pathway approach states "confirming the benefit-risk balance of a product, following a conditional approval based on early data (using surrogate endpoints) considered predictive of important clinical outcomes" https://t.co/yV8xGDoNCA https://t
How good are these proxy outcomes? Between 2002 and 2012, 49% of pivotal trials supporting approved new drug indications used surrogate markers of disease as primary endpoints https://t.co/NGubCIdSdr
RT @YaleSPH: Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on s…
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological #study. https://t.co/nqUe4aSTAF @YaleHPM
RT @jsross119: Since few drugs used same endpoints pre-post market, key is to require postmarket trials using same endpoint (or clinical ou…
Since few drugs used same endpoints pre-post market, key is to require postmarket trials using same endpoint (or clinical outcomes) to validate pivotal trial findings, ensure that early trial results were not exaggerated https://t.co/LRkni75OUa
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
Comparison of effect sizes from pivotal and post-approval trials of therapeutics approved by FDA https://t.co/dnZAINVBiC
RT @LucienHordijk: Opnieuw een tamelijk schokkend paper over het gebruik van surrogaateindpunten in het allerbelangrijkste onderzoek voor e…
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
RT @jtoanle: Surrogate outcomes can shorten the duration, size, and cost of a trial, but there are certain trade-offs to consider...lack of…
RT @HuubSchellekens: Geneesmiddelen blijken op de markt 50% minder effectief dan de fabrikanten claimen bij toelating. We betalen steeds me…
Opnieuw een tamelijk schokkend paper over het gebruik van surrogaateindpunten in het allerbelangrijkste onderzoek voor een handelsvergunning. https://t.co/kM1MYKKyXM
RT @jtoanle: Surrogate outcomes can shorten the duration, size, and cost of a trial, but there are certain trade-offs to consider...lack of…
RT @jtoanle: Surrogate outcomes can shorten the duration, size, and cost of a trial, but there are certain trade-offs to consider...lack of…
RT @BMCMedicine: Comparison of treatment effect sizes from pivotal and postapproval #trials of novel #therapeutics approved by the #FDA bas…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
RT @jtoanle: Surrogate outcomes can shorten the duration, size, and cost of a trial, but there are certain trade-offs to consider...lack of…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
Wijlen Allen Roses (GSK) zei dit al vele jaren geleden. https://t.co/7xYv9S92eP https://t.co/kqDzgQlxUl
Geneesmiddelen blijken op de markt 50% minder effectief dan de fabrikanten claimen bij toelating. We betalen steeds meer voor nog minder dan we denken. https://t.co/KdwAdXqvvm
RT @OrianaCiani: Studi post-marketing difficilmente comparabili con quelli registrativi @US_FDA soprattutto in termini di endpoints. Il nos…
RT @jtoanle: Surrogate outcomes can shorten the duration, size, and cost of a trial, but there are certain trade-offs to consider...lack of…
Surrogate outcomes can shorten the duration, size, and cost of a trial, but there are certain trade-offs to consider...lack of patient importance, erroneous inferences, diminished certainty, and #comparability of trials https://t.co/Jlmvyw9TaF
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
RT @OrianaCiani: Studi post-marketing difficilmente comparabili con quelli registrativi @US_FDA soprattutto in termini di endpoints. Il nos…
RT @Yale_CRIT: New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in…
Studi post-marketing difficilmente comparabili con quelli registrativi @US_FDA soprattutto in termini di endpoints. Il nostro ultimo lavoro https://t.co/kmYX3P1r4u @YaleMed @Yale_CRIT @JoshuaDWallach @hmkyale @gregggonsalves @jsross119 @BioMedCentral @sd
Comparison of treatment effect sizes from pivotal and postapproval #trials of novel #therapeutics approved by the #FDA based on surrogate markers of #disease: a meta-epidemiological study https://t.co/26zYiO7Am6
New article by @Yale_CRIT's @JoshuaDWallach @jsross119 @gregggonsalves @hmkyale et al "highlight[s] the potential problem in the estimation of the magnitude of treatment effects of drugs that are approved based on surrogate markers of disease" https://t.co
RT @JoshuaDWallach: Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trial…
Surrogate markers involve trade-offs & risk making erroneous inferences about clinical effects. Many postapproval trials not comparable to trials used during FDA drug approval, particularly w/ respect to endpoint selection. https://t.co/KPFhgSU5oG @Bio