Insights On Trial Design

  1. Harnessing Predictive Modeling To Overcome Trial Enrollment Challenges 2/28/2025

    By shifting from reactive problem-solving to proactive planning, predictive intelligence ensures clinical trials meet their enrollment goals more efficiently.

  2. Shifting Policies Can Spark Progress In Clinical Trial Diversity 2/13/2025

    Learn how shifting policies create opportunities for the private sector to prioritize innovation in clinical trials for better healthcare.

  3. 'Diabesitology': Novel Trial Designs In The GLP-1 Axis Medications Era 5/15/2024

    Find out how today’s FDA-approved obesity medications are primed to become tomorrow’s novel treatments across multidimensional states of disease — from diabetes to heart failure.

  4. Can Mobile Visits Attract And Keep More Children In Clinical Trials? 4/8/2024

    As sponsors face regulatory pressure to include more pediatric patients in trials, could mobile nurse visits help them enroll more patients from this underrepresented group?

  5. 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.

  6. How Home Trial Visits Support Sites And Patients 3/20/2025

    By reaching into the heart of communities, Home Trial Support plays an invaluable role in driving the development of lifesaving, representative, medicines and therapies.

  7. Phase I Clinical Trial Designs: Bayesian Logistic Regression Model (BLRM) 9/25/2025

    The Bayesian Logistic Regression Model (BLRM) is redefining Phase I clinical trial design by bringing flexibility, precision, and patient-centered safety into early drug development.

  8. Overcoming Barriers To Clinical Trial Participation In Oncology 12/3/2024

    Oncology clinical trials face unique challenges in patient recruitment and retention due to barriers such as awareness, logistical constraints, and eligibility criteria.

  9. Understanding The New FDA Guidance On Decentralized Clinical Trials 2/11/2025

    Explore the evolution of the FDA decentralized clinical trial (DCT) guidance, highlighting key updates on responsibilities, data variability, inspections, and trial design.

  10. Pioneering Strategies For Early-Phase Oncology Trials 2/17/2025

    As the field advances, adaptive methodologies and regulatory shifts redefine early-phase oncology trials, promoting efficiency, flexibility, and equitable access.