Dr Anup Amatya FDA Oncology gives a masterclass on subgroup analysis as introduction to panel 4

Must consider
- sample size / power
- multiplicity
- biological rationale

Should be done when there is persuasive evidence of benefit in overall population

#AACRSciencePolicy

Did you miss the 7/18/2023 FDA-AACR-ASA Workshop on Overall Survival in #Oncology #ClinicalTrials ? Slides & recording are now available:

aacr.org/professionals/…

#AACRSciencePolicy #regulatory #biostats #drugdevelopment #OncTwitter

Love catching Yale Cancer Center being repped, often by Roy Herbst like at today's U.S. FDA -AACR Workshop on How Much Is Enough? Trial Designs for Treatment Regimens with Multiple Phases. I appreciate the focus on the benefit possible through improved design #AACRSciencePolicy

Great to meet Dr Kamal Menghrajani, MD, MS, haematologist and leukaemiologist currently working at the The White House and chat about the intersection of haematology & public health (& the MORPHO trial results) #AACR #AACR 24 #aacrsciencepolicy

.U.S. FDA leaders participate in a Fireside Chat at the FDA-AACR Workshop on Trial Designs for Treatment Regimens with Multiple Phases. FDA Oncology #AACRSciencePolicy

AACR Past President Elizabeth Jaffee moderates this session on Optimizing Perioperative Treatment Regimens at the FDA-AACR workshop on trial design. Jhanelle Gray MD of Moffitt Cancer Center introduces the session. #AACRSciencePolicy Dr. Elizabeth Jaffee @HopkinsKimmel

AACR Past President Elizabeth M. Jaffee and @FDAoncology's Harpreet Singh welcome participants to this joint workshop on Trial Designs for Treatment Regimens with Multiple Phases:  
bit.ly/3QDI4eL #AACRSciencePolicy Dr. Elizabeth Jaffee

In the final session of the FDA-AACR workshop on Trial Design, Harpreet Singh of the U.S. FDA talks about Considerations in Other Therapeutic Areas. #AACRSciencePolicy

Our panel of experts discusses the landscape for perioperative trial designs: Anup Amatya, Valsamo Anagnostou, Paz Vellanki, Thelma Brown, Roy Herbst, Mark Kris, and Craig Tendler. #AACRSciencePolicy U.S. FDA @HopkinsKimmel Translational Breast Cancer Research Consortium Roy Herbst Yale Cancer Center Memorial Sloan Kettering Cancer Center

How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases:
AACR Past President Dr. Elizabeth Jaffee and Harpreet Singh will chair this AACR-U.S. FDA workshop. Join us online May 9. Learn more:
bit.ly/3JULR3I
#AACRSciencePolicy Harpreet Singh, MD

Current Landscape for Perioperative Trial Designs:
Moderated by Erin Larkins of the U.S. FDA, the first session of the workshop, featured Oladimeji Adkinboro of the FDA, Valsamo Anagnostou of @HopkinsKimmel, and Kelly Kidwell of @UMichSPH, who joined virtually. #AACRSciencePolicy

The Cancer Moonshot: Opportunities to Fulfill the Vision of the National Cancer Plan—Roy Herbst moderated an #AACRSciencePolicy session today at #AACR24 , featuring Dr. Kimryn Rathmell Kimryn Rathmell, AACR President Patricia M. LoRusso Patricia M. LoRusso, Dr. Elizabeth Jaffee, and Bianca Islam, MD, PhD, MSc (she/her).

.U.S. FDA's Bernardo Hoddock Lobo Goulart moderated a session on the Future of Registrational Trials With Multiple Arms. The session starts with a presentation by Minghua Shan of Bayer Pharmaceuticals. @Lobo_Goulart #AACRSciencePolicy

- flags importance of considering harm signal if seen across multiple studies (often FDA Oncology uniquely positioned to see this as it has all the data)
- if you have a biomarker-defined population where expect differential effect, should prespecify analysis

#AACRSciencePolicy

Keith Flaherty Mass General Cancer Center summarizes the panel's discussions

- even nonsignificant trends in OS harm warrant consideration
- look at evidence of toxicity / AEs as evidence of potential harm, especially if not anticipated

#AACRSciencePolicy

Uses the example of PROpel & olaparib in metastatic castrate-resistant prostate cancer (mCRPC) & recent ODAC meeting

- efficacy in overall pop largely due to effects in BRCAmut pts
- indication narrowed to only be approved for BRCAmut patients

#AACRSciencePolicy

The FDA-AACR workshop on Trial Designs for Treatment Regimens With Multiple Phases is underway. This day-long workshop will explore the future of registrational trials with multiple arms. Learn more and tune in: bit.ly/3UStliA #AACRSciencePolicy U.S. FDA

How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases:
AACR Past President Dr. Elizabeth Jaffee and Harpreet Singh will chair this AACR-U.S. FDA workshop. Join us online May 9. Learn more:
bit.ly/3Us9fu3
#AACRSciencePolicy Harpreet Singh, MD

Harpreet Singh of FDA Oncology provided closing remarks for the U.S. FDA-AACR Workshop on Trial Designs for Treatment Regimens with Multiple Phases. Recordings and slides will be posted to the AACR website by May 23. bit.ly/44yTJB8 #AACRSciencePolicy

“..it’s unacceptable for patients to experience chronic low grade nausea or diarrhea..” Dr. LoRusso Yale Cancer Center. Excellent presentations & possible ways to improve #doseoptimization by #AACRSciencePolicy FDA Oncology
#bcsm
the.right.dose