Ari

Interests in Patient Reported Outcomes; oncology clinical trials; FDA & EMA product labeling based on PRO endpoints. Views are my own.

[Oncology Brothers @OncBrothers]

Tumor agnostic approvals are becoming more common. 4 new drugs/indications were approved by @US_FDA @FDAOncology for mutation driven malignancies and 3 for skin/soft tissue cancers, here is a summary!

#BRAF #RetFusion #PrecisionMedicine #MedTwitter #OncEd #MedEd @OncoAlert

[Bishal Gyawali, MD, PhD, FASCO @oncology_bg]

Hot off the press!
Do solid tumors undergo spontaneous regression?
Can placebo alone produce response in solid tumors?
We attempt to answer this question in this new study published @eClinicalMed : https://t.co/7RpfL2IknR

[Bishal Gyawali, MD, PhD, FASCO @oncology_bg]

You must have heard about Accelerated Approval and Regular Approval. Now introducing “Premature Regular Approval”. My latest in @Medscape on why bypassing accelerated approval pathway is a net harm. https://t.co/svqYH4zdl2

[Paul Katz @pskatz]

There seems to be an increasing use of the justification for a paper being "little is known". Here is the appearance of this phrase in PubMed. It looks like we know less as time progresses. Little is known about why this trend has developed.

[NatureRevClinOncol @NatRevClinOncol]

What are the main barriers in access to oncology drugs in six different regions? How can this crisis be solved? Carlos Barrios, @GlopesMd, Mastura Md Yusof, @Rubagumyaf, Piotr Rutkowski & @ManjuSengar7 address these questions in a Viewpoint now published: https://t.co/bfsondMCoz

[Patient Journal @PatientJournal]

FDA Guidance on Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments: Old Wine in a New Bottle?
By @Gnanasakthy & colleagues.

Read for free: https://t.co/axcM3aX4XV

https://t.co/UtdYQpN47Z

[Don Thiwanka Wijeratne @Dr_DTW]

Two of the giants in Gobal Oncology, talking about their most passionate topic "Commonsense in Oncology" @oncology_bg #ChrisBooth #grandrounds #QueensUniversity @QueensGlobalOnc @QueensUHealth @QueensuDOM @QHSglobalhealth

[COA Katja (Outcomes Specialist) @CoaKatja]

A Further Great COA publication...."On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective" — Read it on @ResearchGate: https://t.co/ff8ZM1Rltp

[Ari @Gnanasakthy]

@Dr_Meming Usually publications are part of the job and expected. But publications are part of your resume and has the potential to may improve the chances of better future earnings in a different job.

[Jens Lehmann @JLehmann_IBK]

New publication out now🥳
Happy to be involved in this project at @imed_tweets
We set up & evaluated a daily #PROM symptom monitoring for children with cancer
#childhoodcancer

Our trial shows
1️⃣ that daily📆 monitoring is possible
2️⃣ how symptomreports were used in clinical care

[Ari @Gnanasakthy]

This review shows that patient-reported outcomes were assessed in 75% of registration trials of new oncology drugs approved by FDA between 2014 through 2018.
@RTIHS

A review of patient-reported outcome assessments in registration trial... https://t.co/rS0pNOzY35

[Raffaele Giusti @oncoblogger]

Only a Quarter of Phase III Studies Demonstrated Improved #QoL in Advanced #Cancer Setting @JAMAOnc https://t.co/Gt3xGmnnnE

[NatureRevClinOncol @NatRevClinOncol]

In a new Comment now live online, @oncology_bg & Christopher Booth argue for the need to define clinically important overall survival thresholds in clinical trials, taking lessons from quality of life end points: https://t.co/ZQIq2eNwAR #hpeonc

[Bishal Gyawali, MD, PhD, FASCO @oncology_bg]

Published today in @NatRevClinOncol ! Chris Booth and I argue why it is important to define thresholds for clinically important OS/PFS gains in cancer RCTs. We already do that for QOL and non-inferiority trials. Why not for OS/PFS in superiority trials? https://t.co/63xLyar6Ow

[Mel Calvert @drmelcalvert]

Methods primer on #PROs from @KevinWeinfurt and @ReeveBryce @JAMA_current part of @JAMANetwork Patient-Reported Outcome Measures in Clinical Research https://t.co/fnrT7HgyxD

[Ari @Gnanasakthy]

@BellKingKal @NorthTxMSG Is 'How would you rate your overall quality of life' specific?... hmmm.

[Emil Lou, MD, PhD, FACP, FASCO @cancerassassin1]

Source unknown, but this rings so true.

[Brendan Heiden @BrendanHeiden]

@CharuAggarwalMD @oncology_bg @JackWestMD @n8pennell @ADesaiMD @NarjustFlorezMD @Tony_Calles @StephenVLiu @DrJNaidoo @Latinamd @GlopesMd @DrSanjayPopat “The monthly average wholesale price for osimertinib in the United States exceeds $18,000 US dollars. Therefore, although the efficacy of osimertinib is impressive, it cannot extend survival if patients cannot even afford it.” Powerful words… important piece! @CharuAggarwalMD

[Bishal Gyawali, MD, PhD, FASCO @oncology_bg]

It was a fun but thought-provoking exercise to write this editorial with @CharuAggarwalMD for the AENEAS trial published in @JCO_ASCO. This editorial touches on several key Qs: role of global trials, me-too products, price competition, control arm, etc. https://t.co/IAPF7ekYng

[Bishal Gyawali, MD, PhD, FASCO @oncology_bg]

Maybe there was no space to write that the control arm was gamed, and despite that the PFS didn’t translate to OS, and QOL didn’t improve either.