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We're getting ready to welcome you online tomorrow, July 17, for the FDA-ASCO Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop! #OCEOutcomes20 ow.ly/p6aH50AAceq

Really excited to hear about project patient voice which will allow healthcare providers to access PRO data collected from cancer trials. This will allow providers to be armed with information that can guide treatment expectations #OCEoutcomes20 #PROs

Why timing really matters in #pro assessment. Bellinda King-Kallimanis describes how we may miss important side effects if we assess #PROs day 1 of treatment cycle -are frequent brief assessments the way forward? #OCEOutcomes20 Paul Kluetz Vishal Bhatnagar, MD FDA Oncology CPROR

Happening now: FDA Oncology ASCO COA-CCT workshop Session 2, moderated by Bellinda King-Kallimanis - and important discussion about PRO assessment frequency #OCEOutcomes20

Folks you can't ask the right question at the wrong time! Timing of #PRO measurements must adapt as #cancer treatments (esp. their mechanisms, targets, etc) evolve!! FDA Oncology's Sundeep Agrawal tackles the timing challenge at ASCO FDA Oncology #OCEOutcomes20!

Like this panel, trial design for #PRO needs clinician, psychometrician, statistician and patient input! Expected toxicity and timing, right tool, strong analysis methods and objectives that are meaningful to patients. #OCEOutcomes20

Patient-reported overall side effect bother is key to assessing tolerability. Listen to Paul Kluetz moderate a discussion w/ Laura Fernandes Gita Thanarajasingam Janet Freeman-Daily Sandra Spivey Preeti Narayan, MD, Dr Sandra Mitchell and Dr David Cella. Tune in now! #OCEOutcomes20

Informative visualization of the timing of FDA review when multiple expedited programs are put in place. A lot goes into hastening the availability of novel treatments for patients with cancer...

FDA’s professional staff have acted with a sense of high urgency during Covid, driven by a shared sense of public health mission; issuing over 60 guidances on accelerating Covid innovation, 750 drugs in mid or late stage trials, a huge review team focused on Covid therapeutics.

Why has the United States handled this pandemic so badly? The Editors note that although we came into this crisis with enormous advantages, our current political leaders have demonstrated that they are dangerously incompetent.

Mo Gaba, who battled cancer and was blind, became part of the fabric in the Baltimore sports community and made a lasting impact on the Ravens. Mo died on July 28, 2020, but his legacy continues to carry on.

Did you know that #FDAOncology supports applied regulatory science research to address practical problems in oncology therapy development? Check out FDA’s Broad Agency Announcement. ow.ly/Xw6r50D3Au1 More info at the #OCEScientificCollaborative: fda.gov/about-fda/onco…

Exciting areas for meaningful #PFDD research! #PROs #RareDisease FDA Oncology

Excited for this workshop, focused on better characterizing patient-reported physical function! FDA Oncology

Today, the FDA issued draft guidance to address which patient-reported outcomes to measure in cancer clinical trials. go.usa.gov/x6KwC

An important draft guidance for those interested in rigorous measurement of PRO in oncology trials!

Listen in to two fantastic sessions moderated by FDA Oncology deputy director Paul Kluetz!

Mark your calendar and register for the FDA 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop focused on patient-reported outcomes in open-label trials. June 29, 2022, 10am-3pm ET #OCEOutcomes22 with Paul Kluetz Vishal Bhatnagar, MD Erica Horodniceanu fda.gov/news-events/fd…

FDA Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop. June 29, 2022. Agenda and session panelist biographies now posted. Click to view full event details. #OCEOutcomes22 with Paul Kluetz Vishal Bhatnagar, MD Erica Horodniceanu bit.ly/39WunoN

Today's the day for FDA's 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop on patient-reported outcomes in open-label trials! 6/29/22 - 10am-3pm ET #OCEOutcomes22 with Paul Kluetz Vishal Bhatnagar, MD #patientreportedoutcomes bit.ly/39WunoN