Paul Kluetz

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

[FDA Oncology @FDAOncology]

FDA today issued draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, to assist medical product sponsors in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.
https://t.co/xOK0jP1Y3q
#DiversityActionPlans #OCEEquityProgram

[FDA Oncology @FDAOncology]

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

[Jennifer Gao @drjennifergao]

@pkluetz @tmprowell @LalehAmiri @DrDonnaRivera

[Tatiana Prowell, MD @tmprowell]

@VivekSubbiah @pkluetz @US_FDA @FDAOncology @montypal @weldeiry @Transplant_Doc @doctorpemm @BldCancerDoc @ErikaHamilton9 @chadinabhan @SarahCannonDocs @AlexSpiraMDPhD @jamecancerdoc https://t.co/VFtyCuthB0 A shout out to Drs.Mirat Shah and Atik Rahman for Project Optimus!

[FDA Oncology @FDAOncology]

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

[Paul Kluetz @pkluetz]

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: https://t.co/OgwKG69Afi

[Paul Kluetz @pkluetz]

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.

[Paul Kluetz @pkluetz]

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.

[FDA Oncology @FDAOncology]

#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
https://t.co/vK6ujBPUVg

[Paul Kluetz @pkluetz]

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

[Paul Kluetz @pkluetz]

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
https://t.co/V1y0hi8K51

[Paul Kluetz @pkluetz]

@Dr_RaviMadan @NCIResearchCtr @theNCI Well deserved Ram!

[Paul Kluetz @pkluetz]

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 https://t.co/psHTMeONhj

[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. https://t.co/ApHCIefJTn

[FDA Oncology @FDAOncology]

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).
https://t.co/LLGCPwne31
#OCEProjectEquity #FundingFriday

[FDA Oncology @FDAOncology]

FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval https://t.co/RQUrzPXY8B

#AcceleratedApproval #cancer #drugdevelopment #FDAGuidance

[FDA Oncology @FDAOncology]

Irreconcilable Differences: The Divorce Between Response Rates, Progression-Free Survival, and Overall Survival. Commentary by #FDAOncology authors via @JCO_ASCO 📈 📉
https://t.co/JjX7an8P0k

#OCEPublications #clinicaltrials #drugdevelopment

[pallavi mishra-kalyani @pmishrakalyani]

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

https://t.co/OyZM7D4OZU

[FDA Oncology @FDAOncology]

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

[FDA Oncology @FDAOncology]

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology https://t.co/IJBpwcoKml via @JAMAOnc.

@sundeeponc @LalehAmiri @LolaFashoyinAje @GautamMehtaMD @harpreet_md @realrickpazdur @pkluetz @DrJuliaBeaver

[Amylou Dueck, PhD @BiostatGirl]

@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