Joshua D. Wallach @JoshuaDWallach
Assistant Professor of Epidemiology, @EmoryEPI @EmoryRollins. Meta-research, @PaulMcCartney, and pizza enthusiast. All views expressed here are my own. New Haven, CT Joined February 2017-
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CRRIT, led by @DrMichaelMensah, @Ayman_Mohammad_, @juliaetkin, @jsross119, & @reshmagar, has submitted comments on @US_FDA's guidance on "Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products."
@US_FDA approvals using Real-time Oncology Review were often based on trials using surrogate markers as endpoints and lacked confirmatory trials, this study finds. @Yale_CRRIT @MaryamMooghali @jsross119 @JoshuaDWallach @TheWonkologist @reshmagar ja.ma/4bgd0to
Premarket Evidence and Postmarketing equirements for Real-Time Oncology Review Indication Approvals by @US_FDA jamanetwork.com/journals/jaman… via @reshmagar et al
No - @MaryamMooghali & colleagues found that despite most RTOR cancer drugs receiving traditional approval based on surrogate markers, @US_FDA mostly did not mandate postapproval studies, unlike with accelerated approval, leaving continued uncertainty of their clinical benefit.
New @JAMANetworkOpen study finds that 1 in 5 cancer drugs were approved through @US_FDA's Real-Time Oncology Review program (shorter review, faster approval), many of which were based on surrogate markers - Did FDA ask for confirmation of clinical benefit?jamanetwork.com/journals/jaman…
Grilling the data: application of specification curve analysis to red meat and all-cause mortality jclinepi.com/article/S0895-… via @DenaZera et al
Massively important study showing once again that if you want to know the outcome of a treatment, you need to measure the outcome and not just something you believe (often wrongly) to be causally associated with it. @raj_mehta @JamesLind1753 @sfinnikin @oncology_bg
Massively important study showing once again that if you want to know the outcome of a treatment, you need to measure the outcome and not just something you believe (often wrongly) to be causally associated with it. @raj_mehta @JamesLind1753 @sfinnikin @oncology_bg
US cancer guidelines do not always inform clinicians that drugs granted accelerated approval failed to show clinical benefit in confirmatory trials. @MaryamMooghali @jsross119 @reshmagar @JoshuaDWallach @BMJMedicine bmjmedicine.bmj.com/content/3/1/e0…
.@jsross119, @JoshuaDWallach and others have an new paper in JAMA out today seeking more FDA transparency on the use of surrogate endpoints outside of oncology - endpts.com/researchers-se…
Remember the study where we looked at the evidence of surrogacy for the surrogate endpoints in oncology listed on the FDA Table of Surrogate Endpoints for approval? thelancet.com/journals/eclin…
Study: Many surrogate markers used for pivotal trials of products to treat non-oncologic chronic diseases lack meta-analyses linking them to outcomes, raising uncertainty of their validity @JoshuaDWallach @Yale_CRRIT raps.org/news-and-artic…
Most surrogate markers used as primary end points in clinical trials to support @US_FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses. ja.ma/4aIRFsR
Great thread about our paper, published today and led by @JoshuaDWallach along with several @YaleMed students. Surrogate markers are increasingly being used in trials, esp those to support FDA product approval, but what’s the evidence to support their use?
Great thread about our paper, published today and led by @JoshuaDWallach along with several @YaleMed students. Surrogate markers are increasingly being used in trials, esp those to support FDA product approval, but what’s the evidence to support their use?
Really proud of this team effort! See thread below to learn more about @Yale_CRRIT & @EmoryRollins effort (31 systematic reviews in one paper!) to evaluate the strength of evidence for surrogate markers used to support FDA approval of drugs treating nononcologic chronic disease.
Really proud of this team effort! See thread below to learn more about @Yale_CRRIT & @EmoryRollins effort (31 systematic reviews in one paper!) to evaluate the strength of evidence for surrogate markers used to support FDA approval of drugs treating nononcologic chronic disease.
New @Yale_CRRIT paper in @JAMA_current: Most surrogate markers used to support FDA approval of drugs treating nononcologic chronic diseases lack high-strength evidence of associations w/ clinical outcomes from published meta-analyses. 1/13 jamanetwork.com/journals/jama/…
This study by @MaryamMooghali and colleagues evaluates the NCCN's guideline recommendations for oncology drug treatments. It analyses accelerated approval status, postapproval confirmatory trials, and alignment with postapproval confirmatory trial results. bit.ly/4aKFXgL
@MaryamMooghali and colleagues analyse the consistency of National Comprehensive Cancer Network's accelerated approval status, post approval confirmatory trials, and guideline recommendation alignment with post approval confirmatory trial results. bit.ly/4aKFXgL
In our new study @BMJMedicine, CRRIT Postdoc @MaryamMooghali examined NCCN guidelines’ recommendations for oncology drug treatments with @US_FDA accelerated approval. @reshmagar @jsross119 @JoshuaDWallach @TheWonkologist @SkydelJ bmjmedicine.bmj.com/content/3/1/e0…
Check out our new study @BMJMedicine to learn about how NCCN guidelines recommend oncology drug treatments with @US_FDA accelerated approval. @Yale_CRRIT @reshmagar @jsross119 @JoshuaDWallach @SkydelJ @TheWonkologist bmjmedicine.bmj.com/content/3/1/e0…
"Together, we will transform how a leading medical journal can improve patient outcomes and population health." #JACC @JACCJournals
Vinay Prasad MD MPH @VPrasadMDMPH
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Joseph Ross @jsross119
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JACC Journals @JACCJournals
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Mitsuaki Sawano, MD @MitsuakiSawano
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أحمد الدغبا.. @aldughpassi
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Yale School of Public.. @YaleSPH
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Maarten van Smeden @MaartenvSmeden
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Reshma Ramachandran @reshmagar
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William Feldman @wbfeldman
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Lauren E. McCullough @Dr_LEMcCullough
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182 Followers 230 Following Inaugural 🪑 of Epidemiology and Population Health @StanfordMed Co-Director @StanPopHealth | Associate Director @StanfordCancer @StanfordEpiNews
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595 Followers 68 Following Medical Statistics; Molecular Epidemiology; Medical Decision Making; Advanced Data Management
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Neel Gandhi @neelrgandhi
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SER @societyforepi
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563 Followers 389 Following Asst. Professor @EmoryEpi. Epidemiologist researching #HIV, #pregnancy, and global women's perinatal health. Views=own.
Kim Witczak 💜 @woodymatters
10K Followers 3K Following Global Pharmaceutical Drug Safety Advocate Speaker/Producer Member,FDA Psychopharmacologic Drugs Advisory Committee #sellingsickness https://t.co/VjIU5WDg9z
Shakira Suglia @ShakiraSuglia
791 Followers 501 Following Professor @EmoryEpi @EmoryUniversity studying Social determinants of health across the life course; childhood adversity; Latino health 🇵🇷
Maryam Mooghali, MD, .. @MaryamMooghali
455 Followers 202 Following Postdoc Researcher @YaleMed @Yale_CRRIT
Anthony So @Anthony_So888
244 Followers 2 Following Professor of the Practice, IDEA (Innovation+Design Enabling Access) Initiative @JohnsHopkinsIH. Tweets & RTs are my views alone.
Boussageon Rémy @BoussageonR
566 Followers 758 Following Professeur Universitaire de Médecine Générale, Lyon 1. Médecin Généraliste PhD, philosophie de la medecine Aucun conflit d'intérêt.
Nik Chaudhry @nikchaudhry_
57 Followers 87 Following Postgraduate Associate @Yale_CRRIT | Alum @EmoryUniversity
Seth Zissette, MS @SZissette
67 Followers 123 Following Epidemiology PhD Student @EmoryRollins | Social, spatial, & HIV/infectious disease epi researcher | MSc @DukeGHI, BA @UNC | 🐏🏃🏼♂️✈️ | he/him/his
SARAH SQUIRM @SarahSquirm
106K Followers 3K Following 🤡 sarah sherman on @nbcsnl 🪱 😛 come see me on tour 𝐋𝐈𝐕𝐄 + 𝐈𝐍 𝐓𝐇𝐄 𝐅𝐋𝐄𝐒𝐇! 🧠
Laurel Bristow, MSc @Laurel_Bristow
8K Followers 331 Following if you came here for science education I am very sorry…
Dr. Dayna Johnson @DrDaynaAJohnson
941 Followers 427 Following Social Epidemiologist working towards eliminating health disparities through improving sleep. I stand for equality!
Emory Health Services.. @EmoryHSR
129 Followers 148 Following Emory's HSRC collaboration between the DOM & DOS in the SOM is committed to advancing healthcare delivery, & outcomes of patients & populations through science.
Georgia CTSA @Georgia_CTSA
1K Followers 491 Following Georgia Clinical & Translational Science Alliance, NIH Clinical & Translational Science Award (CTSA) at Emory, Morehouse School of Medicine, Georgia Tech, UGA
Megan Ranney MD MPH �.. @meganranney
111K Followers 3K Following I fix problems and promote health 🔸️Dean @YaleSPH🔸️ER doc 🔸️ Cofounder @researchaffirm #ThisIsOurLane🔸️she/hersCheck out my latest public comment on @US_FDA’s guidance on the collection of race & ethnicity data in clinical trials, emphasizing concerns about race as a genetic proxy & the need for transparent + effective race-related data collection methods to improve health disparities:
CRRIT, led by @DrMichaelMensah, @Ayman_Mohammad_, @juliaetkin, @jsross119, & @reshmagar, has submitted comments on @US_FDA's guidance on "Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products."
@US_FDA approvals using Real-time Oncology Review were often based on trials using surrogate markers as endpoints and lacked confirmatory trials, this study finds. @Yale_CRRIT @MaryamMooghali @jsross119 @JoshuaDWallach @TheWonkologist @reshmagar ja.ma/4bgd0to
Premarket Evidence and Postmarketing equirements for Real-Time Oncology Review Indication Approvals by @US_FDA jamanetwork.com/journals/jaman… via @reshmagar et al
New @JAMANetworkOpen study finds that 1 in 5 cancer drugs were approved through @US_FDA's Real-Time Oncology Review program (shorter review, faster approval), many of which were based on surrogate markers - Did FDA ask for confirmation of clinical benefit?jamanetwork.com/journals/jaman…
No - @MaryamMooghali & colleagues found that despite most RTOR cancer drugs receiving traditional approval based on surrogate markers, @US_FDA mostly did not mandate postapproval studies, unlike with accelerated approval, leaving continued uncertainty of their clinical benefit.
Grilling the data: application of specification curve analysis to red meat and all-cause mortality jclinepi.com/article/S0895-… via @DenaZera et al
Nothing makes me happier than seeing the growth of my students. The secret to being a good teacher is to get fantastic students. If the students are this good, they’ll make any teacher look good.
Evaluation of Evidence of Statistical Support and Corroboration of Subgroup Claims in Randomized Clinical Trials jamanetwork.com/journals/jamai… via @JoshuaDWallach et al
@RichardLehman1 @raj_mehta @JamesLind1753 @sfinnikin Indeed, very important study!
US cancer guidelines do not always inform clinicians that drugs granted accelerated approval failed to show clinical benefit in confirmatory trials. @MaryamMooghali @jsross119 @reshmagar @JoshuaDWallach @BMJMedicine bmjmedicine.bmj.com/content/3/1/e0…
Incoming #JACC Editor-in-Chief Dr. @hmkyale shares his vision, strategy, & goals for the journal. He welcomes authors & readers to join JACC & be part of the change, improvement, & elevation of CV health & outcomes globally. #Cardiology #CardioX youtu.be/bbHSR6gSCC4?si…
Remember the study where we looked at the evidence of surrogacy for the surrogate endpoints in oncology listed on the FDA Table of Surrogate Endpoints for approval? thelancet.com/journals/eclin…
A fantastic new study now out in @JAMA_current from @JoshuaDWallach @reshmagar @jsross119 and colleagues now provide a comprehensive analysis of the surrogacy of the surrogate endpoints listed on the table for ALL other chronic non-oncologic conditions. A massive effort!…
Massively important study showing once again that if you want to know the outcome of a treatment, you need to measure the outcome and not just something you believe (often wrongly) to be causally associated with it. @raj_mehta @JamesLind1753 @sfinnikin @oncology_bg
Study: Many surrogate markers used for pivotal trials of products to treat non-oncologic chronic diseases lack meta-analyses linking them to outcomes, raising uncertainty of their validity @JoshuaDWallach @Yale_CRRIT raps.org/news-and-artic…
Here are the data. Last page summarizes parents responses over the last 2 years. This is sampled to be representative of TN parents. vumc.org/childhealthpol…
Study: Many surrogate markers used for pivotal trials of products to treat non-oncologic chronic diseases lack meta-analyses linking them to outcomes, raising uncertainty of their validity @JoshuaDWallach @Yale_CRRIT raps.org/news-and-artic…
@JoshuaDWallach @Yale_CRRIT @EmoryRollins Congratulations!
Helpful study from @JoshuaDWallach @jsross119 & co - highlighting the major challenges with surrogate endpoints outside of oncology If we want drugs that work, we need endpoints that provide more certainty of benefit
Main finding 1: For 22 of 37 surrogate markers (59%) for 21 chronic diseases, we identified 0 eligible meta-analysis of clinical trials quantifying the strength of association between the treatment effects measured using the relevant surrogate marker & any clinical outcome. 9/13
Most surrogate markers used as primary end points in clinical trials to support @US_FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses. ja.ma/4aIRFsR
Great thread about our paper, published today and led by @JoshuaDWallach along with several @YaleMed students. Surrogate markers are increasingly being used in trials, esp those to support FDA product approval, but what’s the evidence to support their use?
New @Yale_CRRIT paper in @JAMA_current: Most surrogate markers used to support FDA approval of drugs treating nononcologic chronic diseases lack high-strength evidence of associations w/ clinical outcomes from published meta-analyses. 1/13 jamanetwork.com/journals/jama/…
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