Real-World Data / Real-Word Evidence Insights

  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. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

    Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

  4. RWD Helps Abbvie Bridge Oncology Trial Data Gaps 9/18/2025

    AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.

  5. Developing A Risk-Based Model For Computer System Validation 9/11/2025

    Consultant Richie Siconolfi explores risk factors that can be used to develop a risk-based approach to computer system validation.

  6. 3 FDA Guidance Documents That Shaped Today's Computer System Validation 9/10/2025

    Consultant Richie Siconolfi outlines three FDA guidance documents for evaluating and mitigating risks in validating computerized systems.

  7. 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.

  8. Is Double Programming Really Required For Validation? 3/10/2025

    Double programming has been the gold standard for validation, but technological advancements and improved sponsor oversight of CRO deliverables have introduced more efficient and reliable alternatives.

  9. Meaningful Industry Change Means Balancing Tech And Human Touch 5/6/2024

    Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction.

  10. Embracing Hybrid Trial Design — How, When, & Why To Use It 6/28/2023

    Global Clinical Sciences & Operations Innovation Lead Lewis Millen talks about UCB’s approach to hybrid trial design, how and when it chooses to implement remote and virtual elements, and why a hybrid trial is beneficial to both the sponsor and the patient.