From The Editor

  1. FDA Vs. MHRA Vs. EMA: Differences In Externally Controlled Trials 10/23/2025

    As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

  2. 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.

  3. 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.

  4. Synthetic Control Arms: When Data Stands In For Patients 8/14/2025

    Synthetic control arms replace traditional control groups with carefully matched historical or real-world data, offering an option for rare diseases, ethical constraints, or when high-quality datasets exist. They can speed access to treatments, but success depends on rigorous data matching, upfront planning, and early regulatory engagement.

  5. 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.

  6. Tufts & PACT Release New DCT Analysis 7/7/2025

    We take a closer look at some of the key stats in a new DCT report from the Partnership for Advancing Clinical Trials (PACT), a consortium hosted and facilitated by the Tufts Center for the Study of Drug Development (CSDD).

  7. Why Is Trust Stifling Our RBM Implementations? 3/6/2025

    It’s one thing to implement RBM (risk-based monitoring) components like central monitoring or initial risk assessments, but if you’re still doing 100% SDR/SDV, you’re not maximizing the benefits of this approach. So what’s the holdup?

  8. Pros & Cons Of Using Wearables In Clinical Trials 2/26/2025

    What are the biggest advantages and challenges of using wearables in a clinical trial? And who do you need on your team to add wearables to a trial? These are the questions Bryan Hansen, Ph.D. of Johnson & Johnson Innovative Medicine answers in this Q&A.

  9. Wearables: An Essential For Decentralized Clinical Trials 2/20/2025

    Bryan Hansen, Ph.D., director of Innovative Health at Johnson & Johnson Innovative Medicine, discusses types of wearables, his experience using them in neurological disease clinical trials, and some future plans for these devices.

  10. Why Aren't We Using More Wearables In Clinical Trials? 1/6/2025

    Wearables provide a great means for passive data collection in clinical trials, but implementing them isn’t as easy at it seems. Lauren Sunshine, director, product management, digital health, at BMS, talks about some of the advantages — and challenges — of incorporating DHTs into your trial protocols.