Top Tweets for #SurrogateEndpoints
📣Publicación borradores @IHIEurope
🗓️Apertura ene/27
🔹IHI Call 14 (single)-> 4 topics #NAMs #PersonalisedHealthTech #PatientCare #ATMPs
🔹IHI Call 15 (two-stage)->2 topics #CompassionateUse, #SurrogateEndpoints
🔗https://t.co/yhh7pyMe1P
@HorizonteEuropa
😞A therapy that “works” on paper can still fail patients.
Dr. Sheil dismantles the false certainty around #SurrogateEndpoints & shows why clinicians must reframe conversations around what matters most to patients.
👉️https://t.co/iY2L6cTMmd
#MedTwitter
モデルナ社のmRNAインフルワク💉の認可のための審査申請を却下した先のFDAの決定には、RFK Jr.保健福祉省長官のもとFDA傘下の生物製剤評価研究センター（CBER）所長という公職に就任したVinary Prasad氏 @VPrasadMDMPH の判断が強く働いていたと言えます。
https://t.co/5DmCkFOq80
血液腫瘍内科医で有名医学誌に数多くの論文が掲載された研究者でもあるVinary Prasad氏は、医療問題（がん検診の有効性、ワクチンや抗がん剤の有効性と副作用問題、それらの薬事承認ための臨床試験における諸問題、医学界と製薬企業の利益相反問題など）について、SNS（XやYoutube、ブログetc.）上で旺盛に発信したり、著書を出版したりしていました。
それらについて、私はブログ記事やXなどで共感をもって紹介してきました。
Vinary Prasad氏は、ワクチンや抗がん剤（分子標的薬）など新薬の承認審査のための臨床試験において、対照群（コントロール群）に既存の薬が設定された劣性試験が繰り返されてきたことを問題視し、対照群には基本的にプラセボを設定する必要があると説いていました。
彼の主張は至極真っ当なものであり、RFK Jr.保健福祉長官の基本的スタンスに通底すると言えるでしょう。
モデルナ社の審査申請が却下された基本的理由もそこにありました。
https://t.co/QtiJpgEzVI
しかし残念ながら、審査申請却下の決定はわずか数日後に撤回され、モデルナが修正を加えた形で（対照群のプラセボへの変更ではない）で審査申請が受理されることになりました。
審査申請の却下が撤回され審査申請を受理したことには、いくつかの理由や事情があります。
それを逐一書き出すと長くなりますが、今回の変更をもって「トランプ政権が掲げるMAGHAは欺瞞である」と断罪してしまうのは、社会にある分断をより深める拙速なもの言いになるかと思います。
5️⃣ The biggest illusion: endpoints
PFS ↑
Response ↑
But…
👉 OS?
👉 QoL?
Tumor shrinkage ≠ patient benefit
Always ask: do patients live longer or better?
#SurrogateEndpoints #MedEd
📢 When developing #clinicaltrials, what are the #challenges of #ResponseAssessment with #IOagents beyond #RECIST? Happy to share the contemporary history in development of #IO #ResponseAssessments & how various #surrogateendpoints maybe considered in this situation.
#drugdevelopment @apoddc @APCLC_2023 @CUHKMedicine
#SurrogateEndpoints in oncology trials remain controversial. Our latest article answers 15 common questions, addressing pitfalls and the way forward. Learn why OS and QoL should be the gold standards. https://t.co/AW9ZeWgoY2 #ClinicalTrials @oncology_bg @TheLancet
Excellent summary by @oncology_bg on our recent paper on #SurrogateEndPoints in @eClinicalMed @TheLancet.
Surrogate endpoints in oncology trials remain controversial. Our latest article answers 15 common questions, addressing pitfalls and the way forward. Learn why OS and QoL should be the gold standards. https://t.co/AW9ZeWgoY2 #ClinicalTrials @oncology_bg @TheLancet
Prof Rod Taylor and Dr @AnthonyManyara_ next to our poster on the new SPIRIT-and CONSORT-Surrogate extensions. If at #ictmc2024 come chat with Rod from 12:30pm on reporting surrogate endpoints, its poster number 213.#surrogateendpoints
FINAL REPORT 👇now available from @sitcancer #SurrogateEndpoints Virtual Summit | Pleasure to co-lead #IO Endpoints Working Group | Tackling important questions for future #immunooncology #clinicaltrialdesign #drugdevelopment
#biomarkers
https://t.co/coKtUOawEE
4/ Therefore, it is important that trials using #surrogateendpoints are adequately reported.
Over the last 2.5 years, a multidisciplinary project group has led and coordinated the development of the SPIRIT-Surrogate and CONSORT-Surrogate #reportingguidelines
A crash course on surrogate endpoints in oncology and their use for regulatory approval - @oncology_bg
https://t.co/T7jlKzdeCe
#oncodaily #oncology #cancer #SurrogateEndpoints #RegulatoryApproval #MedicalResearch #ClinicalTrials #MedicalScience
Exactly this is the reason why we need to work on intermediate and #SurrogateEndpoints @UroDocAsh
Beyond surrogate endpoints we need better endpoints reflecting true #patient benefit, including less subsequent treatment, less urological interventions - all this matters beyond OS
Most oncology drugs granted accelerated approval did not demonstrate OS benefit
or improve QOL within 5 years of approval
Need better correlation of surrogate endpoints with what actually matters to patients
https://t.co/qbMWwdbZv5 @JAMAOnc @IBCG_BladderCA #EAU24 #AACR24
Pleasure to participate in @sitcancer #SurrogateEndpoints Summit today & colead #IO Endpoints WG w KOLs from @theNCI @US_FDA industry academia tackling
#trialdesign
#biomarkers
#immunooncology
Report to follow
@MoffittNews
📢New publication in the @JClinEpi as part of the SPIRIT|CONSORT-Surrogate project
Definitions, acceptability, limitations, and guidance in the use and reporting of #surrogateendpoints in #RCTs: A scoping review
https://t.co/LCup4Oo6cX
The last of our commentaries calling for better reporting of #surrogateendpoints in trials has been published in the journal Trials. It is the last project output for 2022 and we hope to share more outputs in the next year.
👇
https://t.co/nXfUsFnZkp
Fabulous oncology grand rounds today by the inestimable Bishal Gyawali on how we need far more rigorous critical thinking when designing and interpreting oncology clinical trials #SurrogateEndpoints #Bias #Pvalues
.@BettinaRyll rightly so disagrees at @EUAccessAcademy's convention that #SurrogateEndpoints are not valuable in the #HTA process. #CancerPatients celebrate any #stablescan. That is benefit! Additional stable scans eventually translate into #OverallSurvival. #PatientVoice
If attending @ictmc2022 #ICTMC2022 and interested in #surrogateendpoints reporting in trials, please help with developing the SPIRIT- and CONSORT-SURROGATE extensions. The Delphi survey closes this Friday the 7th and can be accessed using this link https://t.co/gUuzrw9tZ6
Our latest editorial calling for better reporting of surrogate endpoints in cardio-thoracic trials as part of developing reporting checklists for #surrogateendpoints in trials
https://t.co/h623mWmGz3
Contribute to developing SPIRIT and CONSORT extensions for #trials that use #surrogateendpoints
You can participate in the Delphi survey using this
link 👇
https://t.co/gUuzrvRT7y
#MethodologyMonday
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