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.

Experts in heart failure clinical trials, including Scott Solomon and JoAnn Lindenfeld, discuss the importance of analyzing subgroups in trials. They emphasize the challenges in interpreting data, the impact of therapy, and the need for personalized medicine for better treatment outcomes.

Cardiologists Javed Butler, Mariell Jessup, and Mitchell Psotka discuss the significance of subgroups in heart failure trials. They explore the impact of targeted participant categories, challenges of replicating trial results, and prioritizing subgroups for improved trial outcomes.

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.

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?

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?

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).

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?

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?

Statistical experts Janet Wittes, Eric Leifer, Bill Abraham, and Mitchell Psotka discuss the complexities of Statistical Analytical Plans (S-TEMANs) in heart failure research, emphasizing the importance of clear definitions for accurate estimations. They highlight the need to go beyond P values, focusing on patient reported outcomes and confidence intervals to analyze clinical trial data and make informed decisions.