In the event of a shutdown, the eRA system will still be open. You can submit your applications. However, no one can process them. Peer review and council meetings will not occur. DSMB meetings may occur, and each ICO will likely have a safety officer serve as a exempted POC.
September 30, 2025 at 9:33 PM
In the event of a shutdown, the eRA system will still be open. You can submit your applications. However, no one can process them. Peer review and council meetings will not occur. DSMB meetings may occur, and each ICO will likely have a safety officer serve as a exempted POC.
Science Director of Clinical Affairs Dr. Ralf Hornig said: “The DSMB has confirmed that the PRIMAvera data meets all the necessary requirements. We are thrilled that this brings us one major step closer to being able to get the #PRIMA Implant to many patients who desperately need it.”
December 2, 2024 at 8:23 PM
Science Director of Clinical Affairs Dr. Ralf Hornig said: “The DSMB has confirmed that the PRIMAvera data meets all the necessary requirements. We are thrilled that this brings us one major step closer to being able to get the #PRIMA Implant to many patients who desperately need it.”
Argenica Therapeutics ( #AGN ) has released " Positive DSMB Safety Outcome & Phase 2 Trial Progress Update " on Thu 30 Jan at 09:17 AEST #ClinicalTrials #Australia #ASX #Tech #BioTech
Argenica Therapeutics share price
Argenica Therapeutics (ASX:AGN) is an asset listed on the ASX, and part of the Health Care sector. Grafa’s asset page shows Argenica Therapeutics’s share price,
grafa.com
January 29, 2025 at 10:39 PM
Argenica Therapeutics ( #AGN ) has released " Positive DSMB Safety Outcome & Phase 2 Trial Progress Update " on Thu 30 Jan at 09:17 AEST #ClinicalTrials #Australia #ASX #Tech #BioTech
@exceedhergrasp1.bsky.social Greeting. Any need for a doctoral trained research ethicist and DSMB expert?
April 1, 2025 at 11:09 AM
@exceedhergrasp1.bsky.social Greeting. Any need for a doctoral trained research ethicist and DSMB expert?
Here's a warning letter issued by the FDA's CBER in which serious adverse events occurred in a clinical trial & there's no documentation to indicate that the sponsor-investigator (letter recipient) reported this information to the IRB, DSMB, & independent medical monitor. www.fda.gov/inspections-...
Amy Lightner, MD - 682593 - 03/25/2025
Bioresearch Monitoring Program
www.fda.gov
June 4, 2025 at 5:01 PM
Here's a warning letter issued by the FDA's CBER in which serious adverse events occurred in a clinical trial & there's no documentation to indicate that the sponsor-investigator (letter recipient) reported this information to the IRB, DSMB, & independent medical monitor. www.fda.gov/inspections-...
📄[Press release] – MaaT Pharma Announces Positive Second DSMB Review of Ongoing Phase 2b Clinical Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT🩸
maatpharma.com/january-21-2...
#Microbiome #BloodCancer #Cancer #DSMB #Safety #Tolerability #Phase2
maatpharma.com/january-21-2...
#Microbiome #BloodCancer #Cancer #DSMB #Safety #Tolerability #Phase2
January 21, 2025: MaaT Pharma Announces Positive Second DSMB Review of Ongoing Phase 2b Clinical Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT - MaaT Pharma
maatpharma.com
January 21, 2025 at 5:13 PM
📄[Press release] – MaaT Pharma Announces Positive Second DSMB Review of Ongoing Phase 2b Clinical Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT🩸
maatpharma.com/january-21-2...
#Microbiome #BloodCancer #Cancer #DSMB #Safety #Tolerability #Phase2
maatpharma.com/january-21-2...
#Microbiome #BloodCancer #Cancer #DSMB #Safety #Tolerability #Phase2
✨ Thank you to everyone who joined us for the DSMB Annual Meeting 2025 & Heparan Sulfate Workshop at the University of Copenhagen!
#MatrixBiology #DSMB #HeparanSulfate #ScientificCommunity
#MatrixBiology #DSMB #HeparanSulfate #ScientificCommunity
September 12, 2025 at 2:57 PM
✨ Thank you to everyone who joined us for the DSMB Annual Meeting 2025 & Heparan Sulfate Workshop at the University of Copenhagen!
#MatrixBiology #DSMB #HeparanSulfate #ScientificCommunity
#MatrixBiology #DSMB #HeparanSulfate #ScientificCommunity
Another common reason for meeting futility at the DSMB is the overestimation (clinically unrealistic) of the pre-specified treatment effect.
July 16, 2025 at 3:22 PM
Another common reason for meeting futility at the DSMB is the overestimation (clinically unrealistic) of the pre-specified treatment effect.
ACTG5418: Tecovirimat vs PBO clade 2 mpox n=344 #CROI2025
Study stopped early due to DSMB futility analysis (unbeknownst to study team?!)
25% recruited remotely
HR for clinical resolution....0.98 (o.74-1.31) & no diff in subgroup analysis incl symptom duration. No difference in viral clearance/pain
Study stopped early due to DSMB futility analysis (unbeknownst to study team?!)
25% recruited remotely
HR for clinical resolution....0.98 (o.74-1.31) & no diff in subgroup analysis incl symptom duration. No difference in viral clearance/pain
March 12, 2025 at 7:30 PM
ACTG5418: Tecovirimat vs PBO clade 2 mpox n=344 #CROI2025
Study stopped early due to DSMB futility analysis (unbeknownst to study team?!)
25% recruited remotely
HR for clinical resolution....0.98 (o.74-1.31) & no diff in subgroup analysis incl symptom duration. No difference in viral clearance/pain
Study stopped early due to DSMB futility analysis (unbeknownst to study team?!)
25% recruited remotely
HR for clinical resolution....0.98 (o.74-1.31) & no diff in subgroup analysis incl symptom duration. No difference in viral clearance/pain
wake up babe it's time to log onto my cookie run kingdom account
youtube - www.youtube.com/watch?v=dsMb...
twitch - twitch.tv/punkbrocker
#eldenwood #vtuber #vtlive
youtube - www.youtube.com/watch?v=dsMb...
twitch - twitch.tv/punkbrocker
#eldenwood #vtuber #vtlive
January 27, 2025 at 7:09 PM
wake up babe it's time to log onto my cookie run kingdom account
youtube - www.youtube.com/watch?v=dsMb...
twitch - twitch.tv/punkbrocker
#eldenwood #vtuber #vtlive
youtube - www.youtube.com/watch?v=dsMb...
twitch - twitch.tv/punkbrocker
#eldenwood #vtuber #vtlive
Argenica Therapeutics advances Phase 2 stroke trial after DSMB approval - published 29 Jan 2025 #ClinicalTrials #ASX #Grafa #SEC
Argenica Therapeutics advances Phase 2 stroke trial after DSMB approval
Perth-based <a href='https://grafa.com/company/argenica-therapeutics-ltd-320'>Argenica Therapeutics</a> <a href='https://grafa.com/asset/argenica-therapeutic
grafa.com
January 29, 2025 at 10:47 PM
Argenica Therapeutics advances Phase 2 stroke trial after DSMB approval - published 29 Jan 2025 #ClinicalTrials #ASX #Grafa #SEC
Glenn was chair of the DSMB says they were able to enroll 12 of the 1200 anticipated in the first yer before they decided to shut it down. #KidneyWk
December 1, 2024 at 10:30 PM
Glenn was chair of the DSMB says they were able to enroll 12 of the 1200 anticipated in the first yer before they decided to shut it down. #KidneyWk
The results from our DEVICE trial are out in the @NEJM . In this RCT, direct laryngoscopy was inferior to video laryngoscopy for first-pass success.
In fact, it was so inferior that we had to stop the trial early after DSMB review due to the clear benefit of VL.
In fact, it was so inferior that we had to stop the trial early after DSMB review due to the clear benefit of VL.
June 16, 2023 at 6:07 PM
The results from our DEVICE trial are out in the @NEJM . In this RCT, direct laryngoscopy was inferior to video laryngoscopy for first-pass success.
In fact, it was so inferior that we had to stop the trial early after DSMB review due to the clear benefit of VL.
In fact, it was so inferior that we had to stop the trial early after DSMB review due to the clear benefit of VL.
#VXRT Vaxart Announces Favorable DSMB Review of Sentinel Cohort from COVID-19 Phase 2b Clinical Trial
https://www.stocktitan.net/news/VXRT/vaxart-announces-favorable-dsmb-review-of-sentinel-cohort-from-covid-8prsdiisse2e.html
https://www.stocktitan.net/news/VXRT/vaxart-announces-favorable-dsmb-review-of-sentinel-cohort-from-covid-8prsdiisse2e.html
Vaxart's Oral COVID Vaccine Advances: Safety Board Backs Phase 2b Trial Expansion to 10,000 Patients
Independent safety board endorses Vaxart's oral COVID-19 vaccine trial after reviewing initial 400-participant data. Plans $460.7M BARDA-funded expansion pending FDA approval.
www.stocktitan.net
January 14, 2025 at 12:55 AM
#VXRT Vaxart Announces Favorable DSMB Review of Sentinel Cohort from COVID-19 Phase 2b Clinical Trial
https://www.stocktitan.net/news/VXRT/vaxart-announces-favorable-dsmb-review-of-sentinel-cohort-from-covid-8prsdiisse2e.html
https://www.stocktitan.net/news/VXRT/vaxart-announces-favorable-dsmb-review-of-sentinel-cohort-from-covid-8prsdiisse2e.html
According to Dr. Kiley (from Piller) “The DSMB assesses whether there is a statistically different pattern of events between the intervention and control arms of the study. Broken bones would be reportable as adverse events to these oversight bodies. No safety concerns were identified.”
26/n
26/n
January 17, 2025 at 3:33 PM
According to Dr. Kiley (from Piller) “The DSMB assesses whether there is a statistically different pattern of events between the intervention and control arms of the study. Broken bones would be reportable as adverse events to these oversight bodies. No safety concerns were identified.”
26/n
26/n
Sauf qu'évidemment, lorsque je participe à un DSMB, je ne fais pas autre chose. Donc comme toujours, le coût est un coût d'opportunité (comme pour le reviewing, la participation aux comités divers, etc etc...)
November 14, 2023 at 11:17 AM
Sauf qu'évidemment, lorsque je participe à un DSMB, je ne fais pas autre chose. Donc comme toujours, le coût est un coût d'opportunité (comme pour le reviewing, la participation aux comités divers, etc etc...)
Teaching Dapper Dev The Basics Of Critical Thinking www.youtube.com/watch?v=dSMb...
Teaching Dapper Dev The Basics Of Critical Thinking
YouTube video by Dark Brandon
www.youtube.com
October 23, 2025 at 2:50 AM
Teaching Dapper Dev The Basics Of Critical Thinking www.youtube.com/watch?v=dSMb...
Sorry-
DSMB = data *&* safety monitoring board
DSMB = data *&* safety monitoring board
September 6, 2025 at 9:02 PM
Sorry-
DSMB = data *&* safety monitoring board
DSMB = data *&* safety monitoring board
PolyPid Continues Phase 3 Trial with DSMB Approval and Secures Additional Funding
https://wsnext.com/542d859-PolyPid-clinical-trial/
https://wsnext.com/542d859-PolyPid-clinical-trial/
PolyPid Continues Phase 3 Trial with DSMB Approval and Secures Additional Funding
Petach Tikva, Wednesday, 25 December 2024.PolyPid Ltd. advances its SHIELD II Phase 3 trial for D-PLEX100 with a DSMB recommendation, planning to complete enrollment by Q1 2025 and secure $14.5 millio
wsnext.com
December 25, 2024 at 8:55 PM
PolyPid Continues Phase 3 Trial with DSMB Approval and Secures Additional Funding
https://wsnext.com/542d859-PolyPid-clinical-trial/
https://wsnext.com/542d859-PolyPid-clinical-trial/
I want DOGE to do so my Type 5s, DSMB meetings, and CITI trainings if they're going to do this.
April 13, 2025 at 7:03 PM
I want DOGE to do so my Type 5s, DSMB meetings, and CITI trainings if they're going to do this.
DSMB Recommends Continuation of Phase 3 Study of Bria-IMT in Metastatic #BreastCancer. #BCAM #oncolgy #BreastCancerAwarenessMonth
www.onclive.com/view/dsmb-re...
www.onclive.com/view/dsmb-re...
DSMB Recommends Continuation of Phase 3 Study of Bria-IMT in Metastatic Breast | OncLive
A data safety monitoring board recommended the continuation of a study of Bria-IMT plus immune checkpoint inhibition in metastatic breast cancer.
www.onclive.com
October 22, 2025 at 3:44 PM
DSMB Recommends Continuation of Phase 3 Study of Bria-IMT in Metastatic #BreastCancer. #BCAM #oncolgy #BreastCancerAwarenessMonth
www.onclive.com/view/dsmb-re...
www.onclive.com/view/dsmb-re...
Klinkt wel goed. Spuiten van 10 of 20mL, of bekijken we dat tijdens fase 2? Kurt mag wel in de DSMB zetelen
February 4, 2025 at 6:27 PM
Klinkt wel goed. Spuiten van 10 of 20mL, of bekijken we dat tijdens fase 2? Kurt mag wel in de DSMB zetelen
#PLRX Pliant Therapeutics Announces Next Steps Following DSMB Recommendation on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis
https://www.stocktitan.net/news/PLRX/pliant-therapeutics-announces-next-steps-following-dsmb-hg3ibjikgojv.html
https://www.stocktitan.net/news/PLRX/pliant-therapeutics-announces-next-steps-following-dsmb-hg3ibjikgojv.html
Pliant's IPF Drug Trial Hits Unexpected Hurdle: Expert Panel Called for Urgent Review
Pliant assembles expert panel to assess BEACON-IPF trial data after safety board recommends pause. Review expected within 2-4 weeks while maintaining trial integrity.
www.stocktitan.net
February 13, 2025 at 1:00 PM
#PLRX Pliant Therapeutics Announces Next Steps Following DSMB Recommendation on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis
https://www.stocktitan.net/news/PLRX/pliant-therapeutics-announces-next-steps-following-dsmb-hg3ibjikgojv.html
https://www.stocktitan.net/news/PLRX/pliant-therapeutics-announces-next-steps-following-dsmb-hg3ibjikgojv.html
If DOGE tells me what I may or may not post in FOAM, then I insist they take care of all my DSMB correspondences, my Type 5s, and my data user agreements. I'm 100% certain Big Balls does not have CITI and No FEAR training. Make them take those, too.
April 13, 2025 at 1:22 AM
If DOGE tells me what I may or may not post in FOAM, then I insist they take care of all my DSMB correspondences, my Type 5s, and my data user agreements. I'm 100% certain Big Balls does not have CITI and No FEAR training. Make them take those, too.