Insights On Trial Design

  1. Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays 9/25/2025

    Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

  2. Outlook Good For 7 Drugs Up For Q3 Review 8/15/2024

    A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.

  3. Retention Through Intention — Designing Truly Patient-Centric Trials 2/4/2026

    High drop-out rates threaten clinical trial integrity. Implementing decentralized solutions and proactive support strategies during protocol design can significantly improve patient enrollment and retention.

  4. What Is Direct-To-Patient Clinical Trial Recruitment? 4/28/2025

    What is the direct-to-patient (DtP) recruitment, and how can sponsors and organizers leverage this approach to boost patient recruitment and achieve clinical trial goals?

  5. The New Playbook For Clinical Trial Patient Recruitment 10/20/2025

    From digital-first engagement to data transparency and community trust-building, consider this roadmap for transforming patient recruitment into a repeatable, measurable engine for trial success.

  6. Adapting Clinical Strategies For Rapid Response 12/5/2024

    This presentation aims to equip sponsors, researchers, and stakeholders with the tools to enhance trial resilience and ensure continuity in today’s unpredictable global landscape.

  7. Ensuring A Diverse Patient Population In Clinical Trials 12/13/2024

    In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.

  8. Disclosure Management System: Build Or Buy? 6/19/2025

    Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

  9. Phase 1 Clinical Trial Designs Explained: BOIN, CRM, BLRM, And Modern Adaptive Strategies 9/25/2025

    As precision medicine evolves, trial designs must increasingly accommodate personalized therapies, adaptive strategies, and AI-driven modeling.

  10. Reassure Patients About Benefits Of Clinical Trial Participation 10/29/2025

    Gaining a patient’s trust is the first step to trial participation. Find out how to address this in From Cautious to Committed, the first of a three-part webinar series covering strategies across the patient recruitment continuum.