Paul Kluetz

896 posts

Paul Kluetz

@pkluetz

med onc, interested in trial design, endpoints and scientifically rigorous measurement of the patient experience- tweets and opinions are my own

Katılım Aralık 2008

251 Takip Edilen1.1K Takipçiler

Paul Kluetz retweetledi

FDA Oncology@FDAOncology·26 Haz

FDA today issued draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, to assist medical product sponsors in submitting these plans. fda.gov/regulatory-inf… #DiversityActionPlans #OCEEquityProgram

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·25 Haz

TODAY: Join for the FDA 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) Workshop with opening remarks by OCE Deputy Director @pkluetz and Associate Director @vishalbmd #OCEOutcomes24

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Paul Kluetz retweetledi

Jennifer Gao@drjennifergao·20 Eki

@pkluetz @tmprowell @LalehAmiri @DrDonnaRivera

FDA Oncology@FDAOncology

We were thrilled to welcome Dr. Karen Antman to the Icons in Oncology Distinguished Lecture Series and hear about her career and personal perspectives! @BUMedicine #OCEProjectSocrates @drjennifergao

QAM

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Paul Kluetz retweetledi

Tatiana Prowell, MD@tmprowell·1 Eki

@VivekSubbiah @pkluetz @US_FDA @FDAOncology @montypal @weldeiry @Transplant_Doc @doctorpemm @BldCancerDoc @ErikaHamilton9 @chadinabhan @SarahCannonDocs @AlexSpiraMDPhD @jamecancerdoc nejm.org/doi/full/10.10… A shout out to Drs.Mirat Shah and Atik Rahman for Project Optimus!

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·30 Haz

Congratulations to Kelly Norsworthy, MD, @KellyNorsworth2 on her new position as Division of Hematologic Malignancies 1 deputy division director! She's a medical oncologist-hematologist & Team Leader in DHM 1 since 2020 and adjunct assistant professor of oncology @JohnsHopkins

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Paul Kluetz@pkluetz·27 Haz

Please join if you can. Patient generated data to inform the tolerability of drug products… exploring single item overall side effect impact with some fantastic experts in the #PRO field

FDA Oncology@FDAOncology

TODAY: Join for the FDA 8th Annual Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) Workshop with opening remarks by OCE Deputy Director @pkluetz #OCEOutcomes23 Event details: fda.gov/news-events/fd…

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Paul Kluetz@pkluetz·5 Haz

This session did a nice job hearing both sides of the story on early endpoints and accelerated approval in oncology. Kudos to @FDAOncology Angelo De Claro for his balanced perspective.

FDA Oncology@FDAOncology

FDA Oncology’s Angelo De Claro discussing accelerated approval and #OCEProjectConfirm at #ASCO23.

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Paul Kluetz@pkluetz·31 May

Open access article in @TheCancerLetter worth reading. Discusses @FDAOncology Rick Pazdur's perspective on the oncology #drugshortage

FDA Oncology@FDAOncology

Read an interview with OCE Director Richard Pazdur about causes of oncology drug shortages and what the FDA can and can't do to fix it, via @TheCancerLetter open access article.

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·26 Nis

#ONSCongress 4/26- 3:15-5:15p CT: Hemisfair Ballroom 1. Meet @FDAOncology nurses! FDA 101 and Nursing Roles in Unexpected Places Erin Purcell, Jennifer Albert, Natasha Kormanik, Ramya Antony, Keith Marin, Abigail Johnson, Madeline O’Conner, & Laura Wisch ons.confex.com/ons/2023/meeti…

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Paul Kluetz@pkluetz·17 Nis

@ramyathota1 @ShaalanBeg @CraigLipset @timilpatel @stales @mrhskadhim @ASCO Thoroughly enjoyed moderating this panel! Thanks for joining us Ramya.

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Ramya Thota@ramyathota1·17 Nis

Had an incredible time sharing the panel with @ShaalanBeg @CraigLipset @timilpatel @pkluetz @stales @mrhskadhim discussing decentralized clinical trials. Grateful to continue the work @ASCO Form 1572 task force #AACR23 #decentralizedtrials #clinicaltrials #dct #telemedicine

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Paul Kluetz@pkluetz·10 Nis

The ORISE fellowship program has been such a productive opportunity for early career scientists to work with FDA on applied research questions @FDAOncology @Meena_PharmD

FDA Oncology@FDAOncology

Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma. First author @Meena_PharmD, last author @pkluetz #OCEPublications pubmed.ncbi.nlm.nih.gov/36935467/

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Paul Kluetz@pkluetz·6 Nis

@Dr_RaviMadan @NCIResearchCtr @theNCI Well deserved Ram!

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Ravi A Madan M.D.@Dr_RaviMadan·4 Nis

Congratulations 🎉 to Dr. Ram Srinivasan👏🏼 for his appointment as a Sr. Investigator w/tenure @NCIResearchCtr @thenci. His work has impacted so many patients w/#KidneyCancer #RCC & #VHL. He continues research efforts with many ongoing studies. ccr.cancer.gov/staff-director…

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Paul Kluetz@pkluetz·5 Nis

Excited to kick off this year's great line up of @FDAOncology regulatory science sessions by moderating an #AACR23 panel on #DecentralizedTrials for #Oncology #ClinicalResearch. Looking forward to seeing everyone in Orlando! Session details here bit.ly/3nnH9Dy

AACR@AACR

Adaptations to the #COVID19 pandemic showed that decentralized oncology trials are feasible. On Sunday, April 16, @FDAOncology Deputy Director Paul Kluetz will moderate a panel discussion on how to make these changes permanent at #AACR23. bit.ly/3nnH9Dy

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·31 Mar

Applications due April 3 for #FDA #RFA for Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of #Underrepresented #Populations in #Oncology Therapeutic Development (U01). grants.nih.gov/grants/guide/r… #OCEProjectEquity #FundingFriday

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·24 Mar

FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval fda.gov/news-events/pr… #AcceleratedApproval #cancer #drugdevelopment #FDAGuidance

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·23 Mar

Irreconcilable Differences: The Divorce Between Response Rates, Progression-Free Survival, and Overall Survival. Commentary by #FDAOncology authors via @JCO_ASCO 📈 📉 ascopubs.org/doi/full/10.12… #OCEPublications #clinicaltrials #drugdevelopment

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Paul Kluetz retweetledi

pallavi mishra-kalyani@pmishrakalyani·1 Şub

Incredibly excited to share a very informative #FDA guidance on #externalcontrols hot off the presses! So proud to have led the #statistics effort on this one, in conjunction with colleagues across @US_FDA including @FDAOncology fda.gov/regulatory-inf…

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·14 Oca

We enjoyed meeting with Heme/Onc Fellowship Program Directors from @NorthwesternMed @Yale @BrownUniversity @universityofky @OHSUSOM to discuss ways to collaborate and advance #drugdevelopment education in clinical training! @muntheloon @Reema_PatelMD @timilpatel @drjennifergao

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Paul Kluetz retweetledi

FDA Oncology@FDAOncology·10 Oca

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology ja.ma/3QxttQH via @JAMAOnc. @sundeeponc @LalehAmiri @LolaFashoyinAje @GautamMehtaMD @harpreet_md @realrickpazdur @pkluetz @DrJuliaBeaver

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Paul Kluetz retweetledi

Amylou Dueck, PhD@BiostatGirl·10 Ara

@GitaThanaMD presenting the In4M study during the digital technology scientific workshop. Solutions to study challenges include modified eligibility criteria and patient outreach to help with wearable devices issues. #ASH22 @cpgYALE @pkluetz

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Keşfet

@vishalbmd @tmprowell @LalehAmiri @DrDonnaRivera @VivekSubbiah @US_FDA @FDAOncology @montypal