Aspired to be a plain “trialist” but ended up looking at 170+ cancer drug registration trials since 2006: “Study Time Estimates Using Surrogate End Points vs Overall Survival in Oncology Clinical Trials” ja.ma/2K3bP8L

Published just now in JAMA Internal Medicine . Our assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. jamanetwork.com/journals/jamai… @SpencerPHey Aaron Kesselheim Program On Regulation, Therapeutics, And Law Brigham and Women’s Research Queen's Health Sciences

The biggest honor, however, is to have 2 editorials accompany our paper. I always lamented Richard Lehman ‘s retiring from BMJ blogs without getting chance to read his comment on my work. But now he has written an editorial instead with Cary Gross . jamanetwork.com/journals/jamai… 🙏

Another brilliant editorial is from Zeke Emmanuel et al. You’ll enjoy every word of this. jamanetwork.com/journals/jamai…

And here’s the story covered by @rrichardh in the NPR : npr.org/sections/healt…

“Clinical trials are there to serve patients, not the other way around.” —Bishal Gyawali, MD, PhD, FASCO #ASCO19 #bcsm #lcsm #crcsm #mmsm

In light of today’s #ASCO19 plenary, please read our latest JAMA Internal Medicine paper on accelerated approval to understand this pathway’s trade offs. We even managed to sneak in a sentence about #olaratumab at the very last moment. jamanetwork.com/journals/jamai… #ASCOplenary #sarcoma

ANNOUNCE failed to meet OS primary endpoint and Olaratumab will be withdrawn after previous initial FDA U.S. FDA approval. #ASCO19 #ASCO2019 #sarcoma #pdgfra

Len Saltz @sloan_kettering listing no-value interventions in #colorectalcancer Anything to add or subtract? #ASCO19 #crcsm

On interpreting #clinicaltrials: When you hear “A HR of __ & a __month diff in PFS,” consider what the control arm is. The interpretation of those #s differs if comparator is placebo/BSC or active control, & if active control, if new drug is an add on or replacement tx. #ASCO19

I find the sicker treatment-refractory patient tend to be on left and the healthier adjuvant/first-line metastatic patient on the right.

Health policy conundrum, 1) gets cancer drug approved faster but more uncertainty 2) might not get drug approved but more certainty of clinical benefit jamanetwork.com/journals/jamai…

I look forward to a response and hope Dr. Scott Gottlieb, MD 🇺🇸 will rectify his mistake & resign from his position at @Pfizer. It would send a strong message about the importance of integrity of current & former federal officials.

Wow amazing online course that changed how I think about oncology drugs, and completed just in time before my first day as faculty tomorrow @edxonline #mooc edx.org/course/the-fda…

Couldn’t agree more, would like to tell my patients how a new therapy will directly help them. “Surrogate End Points and Patient-Reported Outcomes for Novel Oncology Drugs” ja.ma/2nolHiy

Canada's Transparency With Clinical Trial Puts Pressure On U.S. FDA To Reveal More : Shots - Health News : NPR npr.org/sections/healt…

Dr. Christopher Booth reminds us about endpoints that matter to patients. #GI20

Critical Care and the COVID-19 Outbreak in Italy: Early Experience and Forecast ja.ma/2wTgyUH

Friendly reminder that surrogate endpoints like PFS only reduce study time by an average of 11 months - Emerson Chen, et al. 🙂 We shouldn’t proclaim new therapies as “new standard of care”, without showing OS or QOL benefit for patients. #ASCO2020 #asco20 jamanetwork.com/journals/jamai…

Pembro in “TMB high” (10+) cancers - paper published in Lancet Oncol. No difference in OS between TMB high and TMB low. Neverthelessless FDA approved. SMH. OncoAlert