競合リスクがあるときの因果推論の論文がStatistics in Medicineに載りました。「実際のestimandが何であれ、データ解析前にestimandを明確にしておかないと、避けられるはずの推定誤差が生じ、さらに他の避けられない因果エラーを増幅させる可能性がある」がメッセージです。
https://t.co/TaXmXNlxFo
China has now surpassed all other countries in number of new oncology clinical trials launched each year, AND also number of novel active substances (NAS) for cancers launched. @IQVIA_global
https://t.co/hTOHIDdyo6
@hagaetc This is called Left Digit Bias.
It is everywhere, from pricing stuff at 9.99 instead of 10 up to physicians' decisions on performing heart surgery.
https://t.co/UVgiaCfn2H
In the phase 3 ATOMIC trial in resected stage III mismatch repair–deficient colon cancer, adding atezolizumab to modified FOLFOX6 improved 3-year disease-free survival, with a higher incidence of grade 3 or 4 toxic effects, mainly fatigue. Full trial results: https://t.co/XASue2CCiE
Editorial: ATOMIC Energy — Biomarker-Bespoke Adjuvant Therapy for Colon Cancer https://t.co/mEj5Oqw68H
What does the FDA guidance on Bayesian analysis mean for clinical trials? Leading statisticians weigh in: 🧵
💬 Perspective: FDA recommends transparent quantification of prior influence in bayesian analyses and regular supplementary analyses without informative priors to maintain objectivity.
https://t.co/9O6P9Hdouy
Celebrating the draft FDA Bayesian guidance document with our perspective in @JAMA_current. Honored to co-author with Jack Lee (MD Anderson), Lisa LaVange (past director of Office of Biostatistics FDA CDER and president of ASA @AmstatNews ),& my Bayesian inspiration @d_spiegel
The LACOG Gynecology Group, in collaboration with GOG Foundation (@GOG ) and EVA - Brazilian Group of Gynecological Tumors (@br_gynoncgroup), is recruiting patients for the DESTINY-Endometrial01 (LACOG 0124 - EVA | GOG-3098) trial.
#LACOG#SomosTodosEVA#GynecologicalGroup
@BenBleibergMD#TumorBoardTuesday
I was kind of amazed at how quickly SQ Ami was put out there
I think J&J deserves credit (unless I don't know the whole story) for not milking the IV patent life and just sitting on the SQ formulation - but instead getting SQ out there quickly
👏 Congrats @VivekSubbiah & team on their important study in @JCOOA_asco 👉 how @US_FDA Project Optimus is transforming early-phase oncology trials — shifting focus from “maximum tolerated dose” to smarter, patient-centered designs👉huge step forward for cancer research! 💪#ClinicalTrials #ProjectOptimus
Bayesian Designs such as BOIN surpassed 3+3 as the most frequent phase I design. An overall trend towards the adoption of faster, safer, smarter and more patient-centric designs, following FDA Project Optimus.
Great for both patients and scientific community!
🚨 Hot off the press in @ASCO journal @JCOOA_ASCO
👉Pleased to share our study 👉 "Impact of FDA Project Optimus Guidance on Design of Early-Phase Clinical Trials"
📊 Analysis of 367 phase I #oncology trials (2021-2024) reveals Project Optimus is transforming cancer drug development:
📈 Bayesian designs surged 48% → 75%
🎯 30% now include dose-optimization plans
⚖️ Moving beyond max tolerated dose approach
👉This shift toward smarter, more patient-centered trial design marks a pivotal moment in early-phase cancer research @OncoAlert@JCO_ASCO@PamelaKunzMD
#ClinicalTrials #CancerResearch #ProjectOptimus #PrecisionMedicine #FDAGuidance
Open access Link:
https://t.co/V23XDR87IO
I fear the public will never truly realize the immense damage done to our scientific research system and its consequences. A loss of ~$4.5 billion in frozen or cancelled grants with at least 148 impacted clinical trials = 138,000 patients due to be enrolled or already enrolled.
In patients with localized colorectal cancer and PIK3CA hotspot mutations in exon 9 or 20, daily low-dose aspirin resulted in a significantly lower recurrence rate than placebo. Full ALASCCA phase 3 trial results and Research Summary: https://t.co/c5FAYCmKwI
Pembrolizumab combined with platinum-based chemotherapy showed a 39.4% response rate and manageable toxicity as a potential first-line treatment for advanced penile squamous cell carcinoma.
https://t.co/CNIV4cGuJx
In patients with localized colorectal cancer and PIK3CA hotspot mutations in exon 9 or 20, daily low-dose aspirin resulted in a significantly lower recurrence rate than placebo. ALASCCA phase 3 trial results: https://t.co/tKlVyXcgWH
Editorial: An Aspirin a Day for Improved Colorectal Cancer Outcomes https://t.co/lcirZfMNZg
The LACOG Lung Group, is recruiting patients for the TROPICAL-1 (LACOG 0823). This is a single-arm, phase 2 study of datopotamab deruxtecan, carboplatin and pembrolizumab for treatment-naive, active brain metastases from non-squamous Non-Small Cell Lung Cancer and PD-L1 < 50%.
Wild—Bernie Sanders asks: “On one side we have the American Medical Association, American Academy of Pediatrics, and American Public Health Association experts saying vaccines safe and effective, who is on your side?
RFK Jr: um um… [names a few whackos]