The RWD & RWE Podcast

Ep 141 [12 June 2024]: Jason Martin – Where does RWD begin and end: The research site perspective

Ep 141 [12 June 2024]: Conversation with Jason Martin, Managing Director and Founder at Global Outcomes (former COO Signant Health; former SVP Parexel - Global Data Operations; former VP Medidata) – we explored the landscape of clinical site and investigator data that is on the boundaries and borders of traditional RWD, that is, the important but supplemental data that plays a critical role in determining the context for use of site-level RWD to support clinical research. We discussed general principles and approaches of this "site metadata" alone and in conjunction with RWD, use for planning and operational execution of studies and the role of AI in defining and accelerating the adoption of supplemental datasets.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 140 [05 June 2024]: Brent Clough – Actioning Physician Networks for Clinical & Commercial Excellence

Ep 140 [05 June 2024]: Conversation with Brent Clough, CEO at Trio Health and a significant background in financial support and development of meaningful software solutions (e.g., for oncology clinical workflows and RWD) – We discussed the Trio Health model that moves beyond continuous RWD collection, leveraging custom disease networks in order to "understand real-world patients, we must measure how each stakeholder impacts real-world patient performance."Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 139 [29 May 2024]: MaryAnne Rizk PhD – Digital Twins for Clinical Trials & RWE: Two better than one

Ep 139 [29 May 2024]: Conversation with MaryAnne Rizk PhD, Managing Partner of Rizk Management Advisors — Board Member, Advisor, Coach, Investor, and Digital Health Innovator — We had a fun and engaging discussion on how RWE & digital twins revolutionize clinical trials. Discover their role in enhancing trial design, improving outcomes, and promoting sustainability in medical research.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 138 [22 May 2024]: Sam Roosz – Music To Our Ears: RWD-driven Clinical Research

Ep 138 [22 May 2024]: Conversation with Sam Roosz, co-founder and CEO of Crescendo Health (Previously: co-founder and former Head of Life Sciences at Datavant) – We discussed the next generation of clinical research-- moving beyond legacy recruitment and engagement to accelerate research through patient-consented RWD.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 137 [15 May 2024]: Real-World Wednesdays: The ISPOR 2024 Experience ... with distinguished co-host, David Thompson

Ep 137 [15 May 2024]: The ISPOR 2024 Experience! With distinguished co-host, David Thompson, we attended ISPOR 2024 and on this RWW we discussed interesting things we saw/heard/learned. We also heard from other guests and RWW participants about their ISPOR 2024 experience!Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 136 [01 May 2024]: Micha Hanson – Oncology RWD: Seeking, sourcing & linking

Ep 136 [01 May 2024]: Conversation with Micha Hanson, VP Product Partnerships at COTA Healthcare – We discussed the identification and sourcing of oncology RWD and the evolution of linking/connection of various types of RWD.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 135 [24 April 2024]: Craig Lipset – Recap: Enhancing Adoption of Innovative CT Approaches by FDA

Ep 135 [24 April 2024]: Conversation with Craig Lipset, advisor to technology and biopharmaceutical companies, leading universities, and the venture community. He shared a recap and his thoughts on the Enhancing Adoption of Innovative Clinical Trial Approaches by FDA/CDER, public workshop convened by Duke-Margolis on March 19-20, 2024.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 134 [10 April 2024]: Alonzo Sexton MD – The silver lining of a broken bone: Quality RWD

Ep 134 [10 April 2024]: Conversation with Alonzo Sexton MD, a private practice orthopedic surgeon and Founder/CEO of nCight, an RWD company focused on AI-enabled democratization of data to support clinical care and research — We discussed Orthopedic RWD: delivering insights and improving outcomes across independent orthopedic practices, while advancing RWE opportunities.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 132 [27 March 2024]: Emily Zacherle DHSc MS – Implementing Tokenization in a Pragmatic Randomized Trial

Ep 132 [27 March 2024]: Conversation with Emily Zacherle DHSc MS, Associate Director, RWE Partnership Studies – We discussed key learnings & challenges from use of trial tokenization & data linkage within a pragmatic randomized clinical trial: driving efficiencies with early collaborative engagement & at a multi-site level.You can review Emily's ISPOR abstract: https://www.ispor.org/conferences-education/conferences/past-conferences/ispor-2023/program/program/session/intl2023-3666/126006For further background on the topic of linkage of real-world data via tokenization (including the trial tokenization use case):- [EP 2] 4/7/21 with Jason Colquitt: Real-World Data: Integrate to Interrogate (pre-podcast)- [Ep 15] 7/7/2021 with Jason Martin: Linking RWD w/ trial data (pre-podcast)- [Ep 53] 5/11/2022 with Ryan Everist & Danielle Walsh: RWW: Next-generation RWD tokenization- [EP 64] 8/3/2022 with Ryan Moog: RWW: Building the Bridge between Trial data and RWD- [EP 84] 1/18/2023 with Lucinda Orsini: RWW: The Power of Clinical Trial TokenizationDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 131 [20 March 2024]: Sudhir Venkatesan PhD MPH – Correcting underpowered RWD studies due to information bias

Ep 131 [20 March 2024]: Conversation with Sudhir Venkatesan PhD MPH, Director, Medical & Payer Evidence Statistics at AstraZeneca – We discussed correcting underpowered RWD studies due to information bias. Sample size and power calculations are often applied to real-world data (RWD) in the same manner as RCTs, but without the operational control as present in RCTs, the results are subject to greater information bias. Some sources of bias may have little impact on the effect estimate, but they will result in greater uncertainty and potentially in failure to reach desired power if not accounted for while planning. Quantitative Bias Analysis (QBA) provides a useful framework to incorporate estimated bias into sample size calculations for RWD studies.You can review Sudhir's ICPE abstract #153: https://onlinelibrary.wiley.com/doi/10.1002/pds.5687Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.