What separates strong clinical research from misleading conclusions?

Often, it comes down to study design.

In this episode of the Clinical Trial Podcast, Kunal Sampat sits down with Dr. Thomas Newman, Professor of Epidemiology and Biostatistics at UCSF and co-author of Designing Clinical Research, to break down how observational studies actually work.

While randomized controlled trials are often considered the gold standard, observational studies are essential in many real-world settings. But they come with challenges including bias, confounding, and misinterpretation that can lead to flawed conclusions if not handled correctly.

Dr. Newman shares a practical framework to help you design better studies, interpret results more critically, and build a stronger foundation in clinical research.

• When observational studies are more appropriate than randomized trials
• A practical framework for designing observational research
• Key threats to validity: bias, confounding, and chance
• How to interpret associations vs. causal effects
• Strategies for dealing with confounders in analysis
• How to approach statistics with more clarity and confidence

Dr. Thomas Newman, MD, MPH, is a Professor of Epidemiology and Biostatistics at the University of California, San Francisco. His work focuses on applying epidemiologic methods to important clinical problems in child health, including neonatal jaundice, infections in newborns, and cholesterol screening.

He is widely recognized for his contributions to clinical research education and is co-author of Designing Clinical Research and Evidence-Based Diagnosis.

If you want to grow in clinical research, you need more than surface-level knowledge - you need to understand how studies are designed and where they can go wrong.

This episode helps you think like a clinical researcher.

Bringing a high-risk cardiovascular device from concept to patient care requires more than innovation - it requires carefully designed clinical trials, strong operational execution, and close collaboration with regulators and physician investigators.

In this episode of the Clinical Trial Podcast, Kunal Sampat speaks with Nicole Haratani about how cardiovascular device clinical trials are actually designed and run. Nicole is Vice President of Clinical Affairs at Supira Medical and has spent more than two decades working in medical device clinical research, particularly in cardiovascular technologies.

Nicole shares insights from her experience leading clinical and regulatory programs across feasibility and pivotal trials, and explains the operational realities behind Class III device studies.

In this episode, we discuss:

• How cardiovascular devices move from concept to clinical trials
• Designing feasibility and pivotal trials for Class III devices
• How inclusion and exclusion criteria are developed
• Challenges in patient recruitment for cardiovascular studies
• Collaborating with key opinion leaders and investigators
• Working with the FDA during the PMA process
• Career advice for professionals interested in medical device clinical research

If you're interested in cardiovascular device development, clinical trial operations, or building a career in medical device research, this episode provides a practical look at how complex device trials are executed.

Clinical trial budgeting remains one of the biggest bottlenecks in study startups, driving delays, rework, and frustration across sponsors, CROs, and research sites.

In this episode of the Clinical Trial Podcast, recorded live at Research Revolution, a clinical research conference hosted by Florence Healthcare, we take a hard look at why clinical trial budget negotiations continue to break down—and what experienced operators are doing differently.

This conversation brings together sponsor, site, and consultant perspectives to unpack the real drivers of delay, including slow escalation pathways, unclear or inconsistent budget justifications, misaligned expectations, and communication gaps between stakeholders.

Rather than rehashing theory, this episode focuses on practical, experience-driven insights you can actually apply.

In this episode, you'll learn:

• The most common causes of delays during clinical trial budget negotiations
• How sites can create clear, defensible budget justifications without triggering endless revision cycles
• What sponsors look for when approving higher-than-expected line items
• Best practices for internal rate cards, fee schedules, and budgeting templates
• How improved communication and transparency can reduce negotiation friction and speed study startup

This episode features insights from:

1. Kristen McKenna, Senior Manager and Investigator Contracts Lead at Pfizer
2. Heidi Castle, Director of Business Development at Mercy Research
3. Matt Lowery, CEO and Principal Consultant at The Pathways Group

If you're involved in clinical trial budgeting, contracting, or study startup - whether at a sponsor, CRO, or research site - this episode offers practical insights to help you navigate negotiations more effectively and avoid common pitfalls.

Listen to the episode to hear how sponsor, site, and consultant leaders approach clinical trial budgeting and study startup.