Dan Schell articles
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Why Dr. Robert Califf Isn't Pulling His Punches Anymore
1/30/2026
In this exclusive video interview, former FDA commissioner Robert Califf, MD reflects on quality, risk aversion, misinformation, and why clinical trials need sharper focus — not more data.
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Choosing Clinical Research … On Purpose
1/28/2026
Most clinical research careers begin by accident. Rutgers University is trying to change that with formal training programs designed for today’s academic and industry trial environments. Barbara Tafuto, Ph.D., interim program director of the Master’s in Clinical Research Management program at Rutgers University, explains the program’s genesis and potential impact on the industry.
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When Clinical Trials Don't Stop For War
1/23/2026
When war halted clinical trials in Ukraine, sites adapted instead of shutting down. Dr. Anna Titkova explains how patients, investigators, and sponsors kept research moving when conditions were anything but stable.
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The Case For Research-Naive PIs
1/9/2026
Carrie Lewis, executive director, clinical program optimization, at Keenova (formerly Endo) explains why research-naive PIs may improve trial quality, challenge assumptions about ROI, and help fix a shrinking investigator pipeline.
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The Hidden Work That Keeps AMC Trials Moving
12/29/2025
After a chance LinkedIn connection led to a conversation with Paul Antaby of MD Anderson, I got an inside look at how clinical trials really operate inside a major academic medical center. From material transfer agreements and data governance to recruitment, scale, and CRC burnout, this interview reveals the hidden work that keeps AMC trials moving — and why they operate so differently from community sites.
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2 Expectations & 2 Warnings For The Year Ahead
12/19/2025
Just when I thought I was done with 2026 predictions for the clinical trial industry, three members of my editorial board emailed me some great ones, hence, part 3 of this series. What’s interesting is that two of these submissions, coincidentally, are focused on optimism for AI. In contrast, Denise Bronner’s forecast for the coming year is much more … well, dire.
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More 2026 Clinical Predictions
12/17/2025
Part 2 of this 2026 forecast series dives deeper into the operational friction points the clinical trials industry still hasn’t resolved. Industry leaders weigh in on sponsor–site partnerships under strain, the growing tech burden on sites, consolidation across site networks and platforms, the limits of AI hype, and why human connection may end up being the most important “innovation” of all.
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2026 Forecasts From People Smarter Than Me – Part 1
12/12/2025
In Part 1 of this forecast series, leaders from TransCelerate, Genentech, Clinical Performance Partners, Marketcap Consulting, and others weigh in on what’s coming next — from regulatory pressure and RBQM mandates to BYOT momentum, AI reality checks, and the financial rebound many CROs are betting on.
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Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It
12/9/2025
Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.
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Why Feasibility Still Feels Broken
11/24/2025
During an interview with Dresden Whitehead of Avacare Clinical Research Network, her take on feasibility mirrored concerns raised during a 2024 Clinical Leader Live (CLL) webinar. She highlighted repetitive questionnaires, unclear sponsor expectations, and the challenges new investigators face. Combined with insights from the CLL discussion, the article explains why feasibility remains a persistent industry pain point.