To learn cardiovascular clinical trials, I invited Gregg Stone, MD, on the podcast.
Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY.
He has served as the national or international principal investigator for more than 150 national and international multicenter randomized trials and studies (many of which have led to new device approval or indications in the US), has authored more than 3000 manuscripts and abstracts published in the peer-reviewed literature, and has delivered thousands of invited lectures around the world.
With an H-index of 211, Dr. Stone has been recognized in Nature Medicine as one of the most prolific authors in science, and by the Web of Science as among the top 0.01% of cited researchers in science.
Dr. Stone completed medical school at Johns Hopkins University Medical Center, in Baltimore, MD, and his internship and residency at the New York Hospital-Cornell Medical Center in New York City.
He completed his general cardiology fellowship at Cedars-Sinai Medical Center in Los Angeles, CA and subsequently a dedicated fellowship in advanced coronary angioplasty in Kansas City, MO.
Please enjoy my conversation with Dr. Gregg Stone on the Clinical Trial Podcast.
Sponsor(s):
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 12,000 study sites, sponsors, and CROs in 45 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com
SELECTED LINKS FOR THE EPISODE
Dr. Gregg Stone Mt. Sinai Profile
Primary Angioplasty in Myocardial Infarction (PAMI) Trial
Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) Trial
National Heart, Blood and Lung Institute (NHLBI)
Mount Sinai Heart Health System
Center for International Vascular Therapy at Columbia
Cardiovascular Research Foundation
Cardiovascular Institute at El Camino Hospital and Stanford Medical Center
John’s Hopkins University Medical Center
New York Hospital Cornell Medical Center
SHOW NOTES:
[0:22] Background Introduction on Dr. Gregg Stone by Kunal
[4:13] Sponsor Break: Florence Healthcare
[5:25] Dr. Stone joins and explains his background in cardiology clinical trials
- PAMI Trial
- Co-PI with Bill O’Neill and Cindy Grimes
- Primary angioplasty reduced death by ~60%
- Randomized trial
- 22 more randomized trials followed to replicate PAMI trial
- Also experienced with trials on acute myocardial infarction and chronic coronary artery disease
- Worked as study PI for numerous US approved drudge eleuding stents
[11:05] Dr. Stone explains how he became a CO investigator in sponsored clinical trials
- Dr. Stone gives talks on this issues
- Building a network of collaborators interested in similar topics is key
- Be collegial and collaborative with others
[12:55] How did Dr. Stone learn to design clinical trials?
- Understand what is the clinical need
- Define the right randomization approach and patient criteria
- Know that 2/3rds of randomized trials will still be negatives
- When trials fail it is important to explore why: patient pop, too small, not the right criteria, etc.
[17:17] What are some of the biggest challenges in designing and conducting high quality cardiovascular clinical trials?
- Complex projects require attention to detail
- Ensuring sites receive quality training
- Collaborating with the FDA effectively
- Balancing inclusion criteria and recruitment’
- Setting realistic expectations for investigators
[30:42] Considerations for international cardiovascular clinical trials
- No one sized fits all
- Do research internationally helps to determine if different populations respond the same
- Largest limitation is budget
[35:08] Sponsor Break: Florence Healthcare & Slope Clinical
[37:20] Dr. Stone provides his thoughts on real world evidence and pragmatic cardiology clinical trials
- What does real world evidence mean?
- Real world trials can be faster and less expensive
- More difficult to answer complex questions
- Broad study size and more random population can help strengthen understanding
[46:42] Key factors that lead to successful collaboration between sponsors and investigators
- Work with partners that align with your goals
- Make sure you set realistic goals for your study
- Consider the capacity of your partner when designing the study (startup vs large organization)
[53:06] What has made Dr. Stone so successful as a project leader?
- Do the work up front to design the study, case report forms, and protocol well
- Make sure you work with a partner that will listen to your input
- Assess what is the knowledge of the sponsor and other investigators
[56:17] Suggestions, advice, and guidance for how to effectively collaborate with editors when publishing in high impact journals
- Journals value positive and negative trials as both are informative
- Borderline or nuanced trials are more difficult and require more work
[59:33] Advice from Dr. Stone on how to stay current in the landscape of clinical research
- When trying to stay on the cutting edge follow the lead companies and lead people
- If starting out find mentors or researchers that you trust and follow the sources they think are valuable
[1:05:18] Dr. Stone on his inspiration and what keeps him going
[1:07:32] Outro and Sponsor Break: Slope Clinical
