21 December 2022: Aaron Kamauu MD MS MPH, Matt Veatch MBA – RWD/RWE: A Year in Review (2022)

22 December 2021: Conversation with the audience: RWD/RWE: A Year in Review (2022) – An open discussion with the audience on top RWD/RWE stories or topics of 2022 and thoughts leading into a new year.

Live Room Chat:
[00:01] Aaron Kamauu: - your top 2-3 RWD/RWE advancements you’ve seen in 2022 - your top 2-3 RWD/RWE-related news - the 1-2 things you are most excited about for RWD/RWE in the new year
[00:17] Aaron Kamauu: given the time and great participation by you all, given the timing, let's have each of you go through your full lists for all three topics ... and provide some thoughts of things you heard from a previous guest, then we will move to the next person
[00:18] Stuart McCully: ChatGPT is very impressive
[00:18] Matt Veatch: Indeed! I enjoyed "testing" it.
[00:22] Aaron Kamauu: I'm excited to see how some of these collaboration networks/ecosystems advance in the new you as well!
[00:25] Aaron Kamauu: RWD to support design of decentralized research; decentralized reserach methods to create/access more RWD; RWD & decentralized research methods used in concert to support meaningful evidence generation
[00:27] Ryan Moog: ++ to Jane. Wanted to make sure everyone sees the DCT and pragmatic trial language in the US Omnibus bill. It starts around page 3,625 :)
[00:28] Aaron Kamauu: 🙌
[00:28] Stuart McCully: European Health Data Space and DARWIN EU are very exciting now/ future drivers to normalise the use of RWE in regulatory decisions
[00:29] Jane Myles: Perfect explanation Leanne
[00:30] Dan Pucci: I second Leanne’s comment - “such a great forum”. There’s nothing like this as a forum. Kudos to Matt and Aaron. As a new member of the club I look forward to sit back and listen and learn, maybe adding some thoughts in ‘23!
[00:30] Aaron Kamauu: Thanks Dan! It's the audience and participation that makes this work so well!
[00:31] Dan Pucci: CRAACO I find very exciting!
[00:34] Jane Myles: All in on CRAACO here. 💯
[00:34] Aaron Kamauu: I distinctly remember a conversation with you (Kyle) and Tim McGarty at an early SCOPE Summit meeting many years ago about how to bring RWD more systematically to support RCTs
[00:36] Jane Myles: In rare circumstances the folks were all in the room. But probably when the sponsor was about to enter a new TA or take in a very new sort of challenge
[00:47] Jane Myles: I admit that having so many (600?) sources of rwd is daunting. We need SMES like you to help project teams navigate that complexity so they don’t get stuck
[00:49] Leanne Larson: About the FDA program - given that it’s so few studies each year - do we feel the Agency will continue to have study-specific discussions as before? If not, it could really limit the use of RWE in submitted studies
[00:49] Aaron Kamauu: Agreed, as both use cases and RWD sources increase, there is an increasing need to navigate the landscape in an effective & efficient way. This is one of my passions right now! ;-)
[00:50] Aaron Kamauu: https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program
[00:50] Ryan Moog: I see Tom Haskell is in the group-he’d also be one of my first calls to help navigate the admittedly large, complex, and confusing RWD ecosystem. :) It’s a challenge to be sure.
[00:51] Matt Veatch: Couldn't agree more Re: Tom...thanks Ryan!
[00:52] Aaron Kamauu: agree!
[0054] Leanne Larson: Great discussion today - looking forward to more in '23!!
[00:55] Charlie Barr: I would like to hear Tim McGarty if any updates from his perspective. He was a pioneer in getting RWD required for use in Trial feasibility and recruitment. What's the learnings? What's next frontier?
[00:56] Kyle Martin Flickinger: Tim!
[00:57] Matt Veatch: Tim -- Pick your 2023 Wednesday...love to have you as a guest!
[00:59] Aaron Kamauu: Tim texted me saying he's listening in the background while on a client call. Let's find a time to have him on soon :-)