@pkluetz giving an @FDAOncology perspective on DCT and pragmatic trials on the heels of recent published FDA guidances @CancerResrch.
Every trial can integrate pragmatic and DCT elements, and the degree would be context dependent on the disease setting & treatments involved.
Recently we welcomed more than 40 fellows to FDA—in collaboration with @ASCO—for an educational workshop, now in its 10th year. An additional almost 100 fellows joined virtually. What a great group! #OncEdFellows#OCEProjectSocrates#MedEd
FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer without EGFR mutations or ALK rearrangements.
https://t.co/VE3c5Zs5EO
#OCENewsBurst#lcsm
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy.
https://t.co/JjOn54M3xA
#OCENewsBurst
NEW 📣Final FDA Guidance on decentralized #clinicaltrials is out! Covers local labs, imaging, procedures; local healthcare providers; telehealth; informed consent; inv product delivery/accountability; & data mgmt.
#MedTwitter#regulatory#DrugDevelopment
https://t.co/PoejYr1CRJ
Its here!
@US_FDA guidance on Conducting Clinical Trials With Decentralized Elements is out!
Protocols should specify whether
- Telehealth visits is appropriate
- Local health care providers can conduct study visits
https://t.co/2xObvs2aGT
FDA approves lazertinib in combination with amivantamab-vmjw for locally advanced or metastatic non-small lung cancer with specific EGFR mutations.
https://t.co/fxHlXvykLa
#OCENewsBurst#lcsm
A @CCR_AACR article highlights how the FDA-AACR Oncology Educational Fellowship helped four alumni develop their career trajectories. Applications for the next class of fellows are open through Aug 1. Learn more:
https://t.co/BzLosL5ko2
#AACRSciencePolicy@timilpatel@HadidiSamer
Beginning tomorrow, the Cancer Cabinet that @POTUS created to end cancer as we know it - will host a series of virtual conversations highlighting key actions driving progress on priorities for the #BidenCancerMoonshot.
Join us! https://t.co/aRmkqjRDyu
Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship - via @CCR_AACR
✔️ Transformative experience
✔️ Regulatory deep dive
✔️ Mock ODAC
💯 Unique opportunity!
https://t.co/YVP7UNRt34
@timilpatel@drjennifergao#MedEd#OCEProjectSocrates
Online First:
Effect of #ProjectOrbis participation by the Swiss regulator @Swissmedic_ on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
#cancerdrugs
https://t.co/qG4voA3nsT
FDA medical oncologist @timilpatel is joining the @DTRAorg gang for a Tues chat to discuss recent #asco24 abstract re: adoption of decentralized trial elements in cancer clinical trials during pandemic. @CTTI_Trials & FDA collected data from research sponsors h/t @akalali 1/n
⭐️Honored to meet with the visionary Dr. @realrickpazdur whose insights have always inspired me through all these years. It was such an incredible @ASCO !🏆
Working in oncology clinical trials now is amazing, with advancements in #PrecisionMedicine, immunotherapy, ADCs, & much much more. #ASCO24