𝘾𝙧𝙖𝙞𝙜 𝙇𝙞𝙥𝙨𝙚𝙩

#decentralizedtrials are not new, there is a 17+ year history before the pandemic. Prior to COVID I used this slide to show there was substantially more "supply" than "demand". By mid-2020 that supply of capabilities was key for trial continuity. Innovation requires adoption.

@fredtrotter @fredtrotter would love to get access to claims data including the free text fields with NCT numbers for patients who are in a clinical trial. We lack visibility to the out of pocket expenses of trial participants but this data has been tough to source!

As of this morning, I have joined the CMS Digital Services Team! You can read more on my blog: fredtrotter.com/fred-trotter-j…

OCE Deputy Director Dr. @pkluetz sat for a Keynote Fireside Chat with @dtraorg co-co-founder Craig Lipset at the Nov. 6 DTRA annual meeting. The topic of conversation was "Mythbusting and the Future of Decentrialized Cancer Trials." #PatientFocusedDrugDevelopment

New Study: @US_FDA leads the world in approving novel #oncology drugs, reviewing almost twice as fast as the EMA and ensuring faster #patientaccess to lifesaving treatments. Read our latest blog post for the full findings: bit.ly/4gCJiAV

@odwyerpr @FINNPartners @Gil_Bashe @Gil_Bashe has had an amazing journey but he continues to guide and inspire a new generation of future leaders in communications so desperately needed to keep pace with the evolution of healthcare and technology

From a field medic to pharma policy lobbyist to thought leader at one of the world’s largest PR firms, @FINNPartners's @Gil_Bashe has had many chapters in life, and he’s not done yet odwpr.us/3A1TP9B

@dawigbcool @miguelifornia @KamalaHarris @KamalaHQ Yes - you should definitely send that poor woman all of your money. A well known Nigerian prince has set up a crowd fund just for you.

Is this true @KamalaHarris ? Wrong way driving in 2011? @KamalaHQ #KamalaHarris

Good to know who to follow online as we all sport hype from reality to impact our futures

Some FDA guidances take several years to finalize, while others move through the process more rapidly. The guidance on "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products" falls into the latter category, progressing from draft to final form in less than three years. This relatively quick turnaround reflects the urgency and importance of establishing clear guidelines for the use of real-world data (RWD) in regulatory decision making. Released a few days ago, this final guidance is part of the FDA's Real-World Evidence (RWE) program, mandated by the 21st Century Cures Act. It provides recommendations for sponsors and researchers on using electronic health records (EHRs) and medical claims data in clinical studies to support regulatory submissions. The guidance addresses key aspects of RWD utilization, including: 1. Evaluation of data source relevance and reliability 2. Development of study design elements 3. Methods for exposure and outcome assessment and validation 4. Approaches to covariate identification and handling 5. Data quality assurance throughout the data lifecycle Emphasizing the need for rigorous methodology, the document outlines strategies for validating study elements, addressing potential biases, and ensuring data quality. It acknowledges the inherent limitations of RWD sources and provides frameworks for mitigating these challenges. This guidance is a significant step in establishing standards for RWD use in regulatory contexts. It aims to facilitate more efficient evidence generation while maintaining scientific integrity. Implementation will require multidisciplinary expertise and investment in data curation and analysis capabilities. Thanks to LLMs and advances in AI since the publication of the original draft guidance, we have more opportunities today for improving RWD quality and integrity. fda.gov/regulatory-inf…

We brought the DTRA Community together in San Diego last night at #DIA2024 The conversations and connections within our community will undoubtedly lead to continue progress of our mission: global adoption of decentralized methods. Thank you to @Studykik for co-hosting!

Great meetup last night at #DIA2024 with our #CNSSummit community 😃 Already getting excited for #CNSSummit2024! Have you applied to join us? You won’t want to miss it!! web.cvent.com/event/fb464cd1… See you in Boston in November!! 👍

@timilpatel @FDAOncology @ASCO @CTTI_Trials @DTRAorg @pkluetz Thanks for sharing data to understand: ✅Which decentralized methods were used in cancer trials during the pandemic, ✅The challenges involved, and ✅Which methods researchers are prioritizing going forward. With these insights we can work together to remove access barriers.

#Covid19 accelerated the use of decentralized trial (DCT) elements in cancer trials. Our study is the first to evaluate DCT elements used in cancer trials submitted to @FDAOncology & led to marketing approval. Check out our @ASCO abstract - meetings.asco.org/abstracts-pres… #ASC024

@boltyboy Efficiency for thee, But not for me!

I'm curious as to why there's so many cost-effectiveness studies into digital health, and apparently so few into the rest of health care spending

@daphnezohar The CROs and tech vendors have over-relied on non-competes

I don’t know of any CEO that has viewed noncompetes as enforceable for years now. At least FTC will get a win here since it has chosen its M&A battles so poorly ftc.gov/news-events/ne…

@cwhogg Please send a 2x2 slide of the landscape with your logo in the top right corner so I can reply with funding.

Starting a NewCo and am raising $5M at $50M. All I can say is that we are going to assemble the best technologists and scientists in the world and we will use the latest in AI and computation to examine the health records databases of our nation to solve chronic disease. DM me for wiring instructions.

𝘋𝘰𝘦𝘴 𝘦𝘷𝘦𝘳𝘺 𝘵𝘳𝘪𝘢𝘭 𝘪𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 𝘩𝘢𝘷𝘦 𝘢𝘯 𝘦𝘲𝘶𝘢𝘭 𝘢𝘯𝘥 𝘰𝘱𝘱𝘰𝘴𝘪𝘵𝘦 𝘳𝘪𝘴𝘬 𝘮𝘪𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯? This week's @dukemargolis meeting on Adoption of Clinical Trial Innovation has me reflecting on how we first built support for using electronic informed consent in a large pharma. The head of development didn't say yes to "innovation"; they said yes to "risk mitigation" by looking at eConsent as a solution to expensive and risky consent quality mitigation (including signatures, dates, and versions). That left me wondering: Does every trial innovation have an equal and opposite risk mitigation? So I asked ChatGPT...

@GraceCordovano @ZayedYasin @HealthNxtSummit “Healthcare innovation would be so much easier without patients. And providers. And payers Oh and legacy tech platforms.” If it was easy it would have already been done.

Very disappointed to hear @ZayedYasin moderating panel at @HealthNxtSummit on Harnessing the Power of #AI to Transform Clinical Care state “easier to transform clinical care without patients”. 🚩🚩 The future of #AI in clinical care MUST be co-creation WITH patients.

Special @HIMSS report on @medikalife on 11 #eHealthVentures Group portfolio companies heading to Orlando. #Israeli #healthinnovators make a strong presence at the global #healthinformation meeting. @GT_Law @HCNowRadio medika.life/himss-global-m…

.@HIMSS CEO @HalWolfIII and I chat for @HCNowRadio and @medikalife about #cybersecurity, #publicpolicy, #publichealth and more. What's in store for Orlando? This #HealthUnabashed episode airs March 11th: medika.life/himss-2024-wil… #HIMSS2024 #AI #ChatGPT #GenAI @GreggMastersMPH

@eperlste @PerlaraPBC Truly disruptive and brilliant.

After a decade of multiple pivots and a near-death experience, @PerlaraPBC finally has persistent product/market fit.