@pkluetz

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

Joined December 2008
  • Tweets641
  • Following239
  • Followers1K
7Media
Replying to @pkluetz
@pkluetz @tmprowell @LalehAmiri @DrDonnaRivera
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Replying to @VivekSubbiah @pkluetz @US_FDA @montypal @weldeiry @Transplant_Doc @doctorpemm @ErikaHamilton9 @chadinabhan @SarahCannonDocs @AlexSpiraMDPhD @jamecancerdoc
nejm.org/doi/full/10.1056/NE… A shout out to Drs.Mirat Shah and Atik Rahman for Project Optimus!

The Drug-Dosing Conundrum in Oncology — When Less Is More | NEJM

Doses and schedules of oncology drugs are sometimes inadequately characterized before registration trials. The “more is better” paradigm is still used for dose selection, despite the recognition th...

nejm.org
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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
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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.
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Open access article in @TheCancerLetter worth reading. Discusses @FDAOncology Rick Pazdur's perspective on the oncology #drugshortage
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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
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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
@AACR25 Mar 2023
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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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-informati…

Considerations for the Design and Conduct of Externally Controlled

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products

fda.gov
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Replying to @GitaThanaMD
@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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It was a wonderful experience to share my pt perspectives & learn at the @US_FDA Project FrontRunner Mini Symposium yesterday 👆explored moving #clinicaltrials with novel agents to earlier lines in St IV #CRC Lots of insightful discussions 👀forward to more new drugs for more pts
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Great Opportunity to join a fantastic team.
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Thankful to be @ASCO faculty for the 1st time at #ASCO22 with these incredible panelists ➡️ @DrEdKim @jillfeldman4 @LundJenny discussing methods to enhance patient centric clinical evidence generation across the continuum. #RCT #RWD Please join the discussion on June 5th!
ASCO
@ASCO27 May 2022
#ASCO22 Education Session to focus on the role of real-world data in improving #clinicaltrials 📊💻 fal.cn/3oYTG #ASCODailyNews @DrEdKim @cityofhope @DrDonnaRivera @FDAOncology @LundJenny @uncpublichealth @jillfeldman4 @EGFRResisters #RWE

Education Session to Focus on the Role of Real-World Evidence in Improving Clinical Trials

During the 2022 ASCO Annual Meeting Education Session “The Spectrum of Clinical Evidence: Real-World Data to Clinical Trials,” presenters will examine the full spectrum of clinical evidence and...

dailynews.ascopubs.org
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🐊Really honored to be a #40GatorsUnder40! 🧡💙Abundant gratitude to my family, friends, & colleagues for your guidance and collaboration! 🧡💙 Thanks @ufalumni @UFPharmacy. Dream Big, Build Resilience, & Be Kind! Go out there and change the 🌎 #GoGators #GoGreater @FDAOncology
UF Alumni@ufalumni15 Apr 2022
Congratulations to @DrDonnaRivera, associate director for pharmacoepidemiology in the Oncology Center of Excellence at the @US_FDA for being named to #40GatorsUnder40 class of 2022! She is a '12 PharmD and '14 MS graduate of @UFPharmacy. @DCGatorClub #GatorNation #GoGators
Donna Rivera of the U.S. Food and Drug Administration was named to the 2022 40 Gators Under 40 class.

ALT Donna Rivera of the U.S. Food and Drug Administration was named to the 2022 40 Gators Under 40 class.

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Impactful use of #PRO and other patient generated data-> treatment side effects and impacts -> tolerability -> optimizing dose. #projectoptimus #OCEPFDD @vishalbmd #AACR22 #fdaoncology
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Paul Kluetz retweeted
BLOODPAC@blood_pac31 Mar 2022
#BLOODPACSummit @FDAOncology @DrJuliaBeaver I have seen the impact of #BLOODPAC from a clinical standpoint, it has allowed for trial initiation and clinical data getting generated.
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FDA pushes cancer trials to include more elderly people | Science | AAAS science.org/content/article/…

FDA pushes cancer trials to include more elderly people

New guidance aims to improve understanding of drug safety, effectiveness in older adults

science.org
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I have spent a lot of time looking at how patients can generate data on drug side effects in cancer trials. This session will really delve into tolerability, what it means to patients, and how we might better measure it. Tune in if you can. @FDAOncology @vishalbmd #PFDD
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Very proud of this effort in collaboration with several colleagues from @FDAOncology (see list in RT below) reviewing important publications, considerations, and regulatory actions with respect to external control data in oncology: annalsofoncology.org/article…

External control arms in oncology: current use and future directions

Although randomized control trials allow for a comparison of treatment arms with minimal concern for confounding by known and unknown factors, a randomized study is not feasible in certain disease...

annalsofoncology.org
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I remember fellowship fondly. @NCIResearchCtr provided me with a great foundation in cancer research, drug development and patient care… with mentorship by @NCIBillDahut @gulleyj1 and others!
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Great discussion on challenges of BCG shortage moderated by @chana_weinstock at @FDAOncology bladder cancer workshop #FDANMIBC21
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