Dan Schell articles

  1. SCOPE Takeaways On Inclusion And Real Patient-Centricity 2/13/2026

    At SCOPE 2026, two panels made the same point from different angles: the industry understands the barriers to broader recruitment. The real challenge is execution. From embedding inclusion into protocol governance to rethinking recruitability and retention, the message was clear — access will only accelerate innovation if inclusion is built into the system from day one.

  2. My SCOPE Groundhog Day Experience 2/12/2026

    From feasibility inefficiencies to overdesigned trials and overloaded investigative sites, the conversations at SCOPE were thoughtful and candid. The problem isn’t ignorance. It’s execution. Until simplification shows up in shorter timelines, leaner protocols, and measurable relief for sites, we may continue gathering each year to discuss the same issues — with the same data.

  3. Informed Consent Isn't Broken — But It's Barely Working 2/9/2026

    Former FDA Commissioner Dr. Robert Califf has been blunt about what’s wrong with informed consent in clinical trials. In this article, we offer a high-level look at his three-part Substack series, exploring how consent became more about legal protection than patient understanding — and what needs to change.

  4. 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. 

  5. 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. 

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.