The Latest on Linked In
Cardio Pod: Heart of the Matter
Episode 24: Crossover designs and event driven trials in devices
In this episode, host Christopher O’Connor and his colleagues discuss device trials and how they differ from drug trials. The conversation focuses on how device trials can be improved and how to advance device development overall.
Episode 24: Crossover designs and event driven trials in devices
Episode 23: Best Practices for Site-Based Research (Part 3)
Host Christopher O’Connor, MD is joined by Jana Svetlichnaya, MD; Anu Lala-Trindade, MD; and Marshall Brinkley, MD to unpack the challenges of site-based research.
This episode dives into the barriers, obstacles, and opportunities investigators face—and what it truly takes to build and sustain a successful research site.
Episode 23: Best Practices for Site-Based Research (Part 3)
Episode 21: The Roles of Using Data from Real World Evidence to Inform Regulatory Applications
In this episode, host Dr. Christopher O'Connor sits down with Dr. Robert Califf, MD, Nicholaas Honig, JD, Dr. Maria Rosa Costanzo, and Dr. Norman Stockbridge, MD, PhD to explore the role of real-world evidence in advancing therapeutic development and improving patient outcomes.
Episode 21: The Roles of Using Data from Real World Evidence to Inform Regulatory Applications
Episode 20: Social Drivers of Health
In this episode, Christopher O’Connor, MD, sits down with Melvin Echols, MD; JoAnn Lindenfeld, MD; Minnow Walsh, MD; and Wayne Batchelor, MD to explore the role of social drivers of health in heart failure clinical trials.
This discussion stems from an initiative of the Heart Failure Collaboratory (HFC) that led to a publication in JACC: Heart Failure titled “Social Drivers of Health in Heart Failure Trials: An Analysis from the Heart Failure Collaboratory.
Episode 18: Models of Success in Site-Based Research
In this episode, Host Dr. Christopher O’Connor is joined by Dr. Melvin Echols, Dr. Anu Lala-Trindade, Dr. Maria Rosa Costanzo, Dr. Lars Kober, and Dr. Norman Stockbridge to explore key models of success in site-based research. The discussion covers operational efficiency, dedicated research infrastructure, sustainable funding and business models, collaborative partnerships, diversity and patient access, and excellence in quality and compliance.
Episode 18: Models of Success in Site-Based Research
Episode 17: Why is Site-Based Research Broken in the United States?
Hosted by Christopher O’Connor, MD, this episode dives into why site-based research is “broken” — fragmented, inefficient, and weighed down by administrative and regulatory burdens.
Many clinical research sites — especially community hospitals and smaller practices — face inconsistent funding, delayed contract approvals, and limited infrastructure for study coordination and data management.
Join Dr. O’Connor and expert guests Melvin Echols, MD; Anu Lala-Trindade, MD; Maria Rosa Costanzo, MD; Dalane Kitzman, MD, Marat Fudim, MD; and Sumeet Mitter, MD as they unpack the systemic challenges and explore how to create a more efficient, equitable research ecosystem.
Episode 17: Why is Site-Based Research Broken in the United States?
Episode 16: Representation vs. Diversity in Clinical Trials
In this episode, host Dr. Christopher O’Connor is joined by Dr. Christian Guilliod, Dr. Wayne Batchelor, Dr. Mona Fiuzat, and Dr. Orly Vardeny to discuss the need for clinical trials to reflect the populations most affected by disease, emphasizing culturally and demographically aligned recruitment.
They advocate for targeted, site-based strategies and raise concerns about interpreting results from unrepresentative samples.
Episode 16: Representation vs. Diversity in Clinical Trials
Episode 15: Should Investigators Have Access to Trial Data?
In this episode, Host Christopher O’Connor, MD, is joined by Robert Califf, MD; Michael Bristow, MD; Scott Solomon, MD; Marvin Konstam, MD; and Mona Fiuzat, PharmD, to discuss who should have access to clinical trial data amid growing collaboration between academia and industry.
The conversation highlights the importance of transparency, trust, and responsible data interpretation to maintain scientific integrity.
Episode 15: Should Investigators Have Access to Trial Data?
Episode 14: How Can AI Enhance Recruitment in Clinical Trials?
In this episode, experts Jonathan Cunningham, MD; Ankeet Bhatt, MD; Trejeeve Martyn, MD; Anu Lala-Trindade, MD; Sneha Shah Jain, MD; Elise Shalowitz, MS; and Mitchell Psotka, MD join host Christopher O’Connor, MD to explore AI’s role in transforming clinical trials by reducing workload, improving recruitment, and enhancing protocols.
Together, they discuss AI’s use in clinical workflows, continuous evaluation, and inclusive recruitment, stressing the need for healthcare support to maximize success.
Episode 14: How Can AI Enhance Recruitment in Clinical Trials?
Episode 13: Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure
Only with cardiology with nephrology working together can the field of acute decompensated heart failure move forward with respect to kidney related entry criteria & endpoints. We call for standardization to allow for real progress. Host Chris O'Connor invites authors of the HFC, newly published JACC Expert Panel, Anuradha Lala, Maria Rosa Costanzo, Muthu Vaduganathan, Jason Feinman, Mona Fiuzat, and Steven Coca to discuss this HF-ARC initiative.
Episode 13: Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure
Episode 12: The Role of AI in the Future of Clinical Trials and Therapeutic Development
How can artificial intelligence enhance and augment clinical trials? In what ways can it be used responsibly to increase trial efficiency? Host Chris O'Connor invites Martin Cowie, JoAnn Lindenfeld, Scott Solomon, Jon Cunningham, Mona Fiuzat, and Mitch Psotka to discuss the role of AI in clinical trials.
Episode 12: The Role of AI in the Future of Clinical Trials and Therapeutic Development
Episode 11: Importance of Subgroups in Heart Failure Clinical Trials (Part 2)
Host Dr. Christopher O'Connor invites Drs. Scott Solomon, William Abraham, JoAnn Lindenfeld, Brian Claggett, Mona Fiuzat, and Mitchell Psotka to continue discussion of the importance of subgroups in heart failure clinical trials. How can we analyze subgroups and determine the differences between subgroups and special populations?
Episode 11: Importance of Subgroups in Heart Failure Clinical Trials (Part 2)
Episode 10: Importance of Subgroups in Heart Failure Clinical Trials (Part 1)
Host Dr. Christopher O'Connor invites Drs. Javed Butler, Mariell Jessup, and Mitchell Psotka to discuss the importance of subgroups in heart failure clinical trials. How do we appropriately define subgroups? Which groups should be included as standard practice in HF trials?
Episode 10: Importance of Subgroups in Heart Failure Clinical Trials (Part 1)
Episode 9: DSMB Training Academy: Preparing the Next Generation of Members (Part 2)
Dr. Christopher O'Connor interviews the founding members of the data safety monitoring board (DSMB) training team, Dr. David DeMets, Dr. Janet Wittes, and Dr. Thomas Flemming, to continue discussing the importance of training the next generation in clinical trial leadership. Using their extensive experience in clinical trials, they address which practices will best serve future members, and the critical shortage of trained experts.
Episode 9: DSMB Training Academy: Preparing the Next Generation of Members (Part 2)
Episode 8: DSMB Training Academy: Preparing the Next Generation of Members (Part 1)
Drs. Janet Wittes, Mona Fiuzat, Maria Rosa Costanzo, Ana Barac, Barry Greenberg, Vanessa Blumer, and Michael Bristow come together on this episode with Dr. Christopher O'Connor to discuss initiatives to train the next generation of DSMB members. How do we pass on the experience and knowledge of seasoned DSMB members and properly train the next generation?
Episode 8: DSMB Training Academy: Preparing the Next Generation of Members (Part 1)
Episode 7: Are we making progress with the recruitment of women in heart failure trials?
Drs. Mariell Jessup, JoAnn Lindenfeld, Maria Rosa Costanzo, Mona Fiuzat, Bill Abraham, and Wayne Batchelor join Christopher O'Connor to discuss the recruitment of women in HF clinical trials. What has been done so far and where do we go from here?
Episode 7: Are we making progress with the recruitment of women in heart failure trials?
Episode 6: Implications of the Advisory Committee Meetings for the Heart Failure Community
Drs. Peter Carson, JoAnn Lindenfeld, John Teerlink, Orly Vardeny, and Bill Abraham join Dr. Christopher O'Connor to discuss the implications of the FDA Advisory Committee meetings with special focus on three programs: TOPCAT (2:05), PARAGON-HF (15:53), and GALACTIC-HF (30:35).
Episode 6: Implications of the Advisory Committee Meetings for the Heart Failure Community
Episode 5: Diversity in Heart Failure Clinical Trials
Special guests Melvin Echols, Nasrien Ibrahim, Vanessa Blumer, Wayne Batchelor, JoAnn Lindenfeld, and Mitchell Psotka join the podcast to discuss the importance of enrolling diverse populations in HF clinical trials. How can we target a more representative population?
Episode 5: Diversity in Heart Failure Clinical Trials
Episode 4: The Intersection of Heart Failure and the Kidney
James Januzzi, Maria Rosa Costanzo, John Teerlink, Marv Konstam, Bill Abraham, and nephrologist Steven Coca join the podcast to discuss HF and AKI. How should we react to rising creatinine?
Episode 4: The Intersection of Heart Failure and the Kidney
Episode 2: Contemporary Challenges in HF Clinical Trial Design
Expert statisticians Janet Wittes and Eric Leifer join the podcast to discuss hazard ratios, the phenomenon of "hazard ratio drift", and other contemporary challenges in HF clinical trial design.
Episode 2: Contemporary Challenges in HF Clinical Trial Design
Episode 1: What is the Heart Failure Collaboratory?
Join Drs. Christopher O'Connor, JoAnn Lindenfeld, Mitchell Psotka, Scott Solomon, Mona Fiuzat, Bill Abraham, and Peter Carson as they introduce a novel concept known as the Heart Failure Collaboratory (HFC) and discuss how it can contribute to the field of heart failure research.
Episode 1: What is the Heart Failure Collaboratory?
HFC Lean CRF
HFC Reading List
Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure: JACC Expert Panel From the HF-ARC
Dr. Valentin Fuster discusses the February 2025 issue of JACC, which focuses on advancements in heart failure research. The discussion covers five key sections: heart failure with preserved ejection fraction, hypertrophic cardiomyopathy, cardiac amyloidosis, standardization of kidney function, and ICD therapy for primary prevention in heart failure patients. Experts explore emerging therapies, diagnostic thresholds, and the potential impact of blood pressure and genetics on patient outcomes, underscoring the need for comprehensive approaches in managing these complex conditions.
Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure: JACC Expert Panel From the HF-ARC
Responder Analyses Can Be Misleading - A Trial Perspective from FDA Representatives
Drs. Southworth, Psotka, Pomeroy, and Stockbridge offer their perspective on how responder analyses can be misleading for evaluating treatment effects from continuous variable endpoints. They stress that anchor-based analyses of continuous variable endpoints should be used to evaluate the clinical meaningfulness of observed treatment effects in clinical trials.
Responder Analyses Can Be Misleading - A Trial Perspective from FDA Representatives
Conducting Clinical Trials With Decentralized Elements
The Conducting Clinical Trials with Decentralized Elements final guidance provides recommendations regarding the implementation of decentralized elements in clinical trials. By enabling remote participation, decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.
Conducting Clinical Trials With Decentralized Elements
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
The Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. This may improve convenience and accessibility for participants and allow for enrollment of more representative populations, resulting in more generalizable trial results.
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
FDA NEWS RELEASE: FDA Guidance Provides New Details on Diversity Action Plans
The U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product.
FDA NEWS RELEASE: FDA Guidance Provides New Details on Diversity Action Plans
CDRH Launches the Total Product Life Cycle Advisory Program Pilot
FDA’s Center for Devices and Radiological Health (CDRH) announced it is launching the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP is a voluntary program intended to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid development of high-quality, safe, effective, and innovative medical devices first in the world that are critical to public health.
CDRH Launches the Total Product Life Cycle Advisory Program Pilot
HFC COVID-19 Data Capture Form
Download the COVID-Like Illness CRF Template and the related JACC publication “Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel”.
HFC COVID-19 Data Capture Form
Download the COVID-Like Illness CRF Template
Read the related JACC publication “Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel”.
Return to HFC Communications & Resources
HFC Letter - Impact of COVID-19
The mission of the HFC has focused largely on clinical trials, and the impact of COVID-19 on clinical research will be significant.
HFC Letter - Impact of COVID-19
Dear Friends and Colleagues,
The mission of the HFC has focused largely on clinical trials, and the impact of COVID-19 on clinical research will be significant. The FDA has issued the following guidance with suggestions and recommendations. We have offered to collect any questions not addressed in the guidance and pass them along on behalf of HFC members. We hope this will be helpful in answering the many questions we are all facing.
Kind regards,
Mona Fiuzat, Chris O’Connor, JoAnn Lindenfeld, Bill Abraham, Mitch Psotka, Bram Zuckerman, Norman Stockbridge
Heart Failure Collaboratory Co-Chairs and Members
NIH Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19
The purpose of this notice is to provide guidance outlining the flexibilities available to recipients conducting NIH-funded clinical trials and human subject studies, that are impacted by the declared public health emergency for COVID-19.