“Every patient should be eligible, with rational, scientific basis for exclusions” @EdKimMDLCI #AAADV19

#AAADV19 @EdKimMDLCI “every patient should have to opportunity to know about clinical trials”.
Session on eligibility criteria

The @FDAOncology’s Vishal Bhatnagar talking about PROs and their importance in the FDA NDA evaluation. #AAADV19

What is tolerability? And what is tolerable varies from patient to patient. #AAADV19

Lee Jones, colorectal cancer patient and advocate, talking about what is important to patients (sorry for the poor choice of seats when it comes to photos) #colorectalcancer #AAADV19

This really has been a great workshop - ready to learn about #PatientReportedOutcomes #PRO #AAADV19

A HUGE happy 😃 birthday 🎂 to @itsnot_pink who spent her 6th birthday living with MBC at the #AAADV19 workshop! That is a dedicated advocate. ❤️ her and @christeeny513

It’s the we’re at a meeting together Kelly and Nik selfie! This man doesn’t talk the talk, he walks the walk of patient centered. Thank you @Nikhilwagle @count_me_in (and yes, I teared up talking about the #MBCProject and what it means to patients - we want to do trials) #AAADV19

Thank you @tmprowell for inviting me to be a part of this plenary panel with @Nikhilwagle @rschilsky @DrAshaCollins @EdKimMDLCI @xelamb and others. Working together and thinking outside the box (like @science37 does) we CAN improve #clinicaltrials. #AAADV19

About to take the stage for the plenary on decentralized clinical trials 😬 #AAADV19

.@US_FDA deputy commissioner Anna Abram outlines the importance of patients, from including #PROs to broadening eligibility requirements to allow more patients to participate #AAADV19

2/2 EVERY advanced or metastatic patient should be told about trials and encouraged to participate in trials. Tomorrow there is a plenary session (yours truly is a panelist 😊) where we’ll discuss ways to get trials to more patients. #AAADV19

While #monalessa3 allowed men with #metastaticbreastcancer to enroll, no men did. One reason why was stated to be that there are so few men, but when 400+ men/yr die, I argue that lack of incidence isn’t the problem but rather lack of education about trials. 1/2. #AAADV19

The only disadvantage of knowing wonderful @FDAOncology folks like @drjennifergao is that they call on you for questions or comments! #AAADV19

.@FDAOncology pilot RTOR (Real-Time Oncology Review) is a way to identify problems with a NDA before the official application is submitted, allowing feedback to improve the application and avoid unnecessary delays #AAADV19

How can we use RWE to improve getting effective drugs to patients? Palbociclib for men was just approved - 4 years after initial approval. Maybe include RWE from the get go in every trial. Just a thought. From a patient. With mets. Who doesn’t have time to waste. #AAADV19

Trials like to use a homogeneous population but the drug once approved will be used in a heterogeneous group. Trials should reflect the population who will be using the drug, if approved #AAADV19

.@paspears88 taking the podium at #AAADV19

There is a 💩 ton (this is valid medical terminology IMHO) of potentially valuable data that can be used in research #AAADV19

Who knew Medicare claims data is available for research? @aneeshchopra does and he just told everyone at #AAADV19 to run and do research using this data

Looking forward to the first plenary session at #AAADV19 on “Real World Evidence 2.0”. Panelists include patient advocate @paspears88 who has always been stellar at presenting a patient viewpoint.

Still hearing that liquid bx are not ready for prime time BUT @geoff_oxnard thinks it should be done in virtually every clinical trial. We must gather all the data we can to figure out what will help patients as quickly as possible. #AAADV19

Shedding of tumor - and variability thereof - is a potential pitfall, often for people like me with bone mets. If the cells or cell-free DNA doesn’t get into the blood stream we can’t find or evaluate it. #AAADV19

30 min into a discussion on liquid bx no one has mentioned the biggest roadblock I hear as a patient: we can identify mutations but don’t have validated treatments for them - and even if an actionable mutation is identified it may not be what’s driving the cancer #AAADV19

Liquid bx moving forward slower than anticipated, for several reasons. Multiple vendors and academic centers doing different assays is a big one. One study of 24 patients having the same sample analyzed at 4 different vendors showed significant variability in results #AAADV19

Liquid bx has applicability across the cancer spectrum #AAADV19

More on the ways liquid bx can be done and what can be looked for - and most importantly how liquid bx can be used to improve the care of us patients #AAADV19

Learning about liquid biopsy at the @AAADVWorkshop. It truly is looking for a needle in a haystack #AAADV19