Dan Schell articles

  1. RWE Is Growing Up, And Here's Why That Matters 9/29/2025

    Real-world evidence is shifting from the margins to the mainstream of drug development, but data quality, trust, and regulatory clarity remain hurdles. ISPOR is helping set the standards to guide its future.

  2. Seriously … Are We Making Any Progress? 9/25/2025

    Ken Getz’s DPHARM talk revealed how ballooning data collection in trial protocols drives costs, delays, and site burden. New ICH E6 R3 guidance pushes for simpler, more flexible designs, but real progress will require collaboration — and restraint.

  3. Gottlieb Warns Leaner FDA Will Challenge ClinOps 9/19/2025

    Former FDA commissioner Scott Gottlieb told DPHARM attendees the agency is strained by staff losses and slowing policy work—leaving ClinOps teams facing tougher reviews, longer waits, and more uncertainty ahead.

  4. The Dream Is EHR-To-EDC — eSource Is The Wake-Up Call 9/11/2025

    EHR-to-EDC integration promises efficiency but struggles with interoperability, compliance, and site adoption. eSource emerges as the real bridge, with case studies like MSK proving it can cut setup times, boost accuracy, and lighten site workload.

  5. Why More Biotechs Are Starting Trials In Australia 8/27/2025

    Why are so many U.S. biotechs heading to Australia for their first-in-human trials? Speed, cost, and simplicity. In our latest piece, Megan Robertson and Tina Soulis break down how sponsors can move from protocol to first patient in just a few months—while saving money and generating data regulators will accept worldwide.

  6. Why CRO Site Network Strategies Confuse Me 8/6/2025

    As CROs evolve beyond traditional service roles, many are investing in proprietary or semi-integrated site networks to streamline trial delivery, improve patient access, and boost data consistency. This article explores how major players like ICON, Parexel, PPD, and Syneos Health are building or partnering with site networks—sometimes through direct ownership, sometimes through curated alliances.

  7. When Survival Comes First, Trials Come Last 8/1/2025

    Infectious disease PI Dr. Claudia Martorell has long focused on recruiting underserved populations into clinical trials. But amid healthcare cuts, economic instability, and a retreat from DEI initiatives, she’s now watching access unravel. In this interview, Martorell shares what happens when survival takes priority over research — and why diversity in trials is once again at risk.

  8. DCT Benefits Are Proven, Yet Progress Is Slow 7/21/2025

    Despite the clear benefits of decentralized trials—broader reach, better retention, and higher diversity—adoption has been slow. In this interview, Sunny Kumar of Informed Ventures explains how AI is lowering costs, speeding up study builds, and pushing DCTs from fringe to future.

  9. Paving The Way For Sites To Use Their Own Tech 7/17/2025

    The DTRA has released a detailed playbook to help clinical research sites use their own validated technology in sponsor-led trials. The "Bring Your Own Technology" (BYOT) model aims to reduce tech overload at sites, improve efficiency, and preserve regulatory compliance — starting with eConsent as its first use case.

  10. Clinical Trials Get A Council For AI Oversight 7/14/2025

    AI in clinical trials is moving fast — but without clear standards for ethics, transparency, or oversight. Advarra's new Council for Responsible Use of AI in Clinical Trials aims to change that. Founding members Sanofi, Recursion, and Velocity Clinical Research are stepping up to define what “responsible” really looks like.