Clinical Guest Contributors

  1. A Primer For Understanding Psychedelic Clinical Research 12/11/2023

    The emerging field of clinical research on psychedelics brings a unique and transformative approach to CNS drug development. Explore more.

  2. Are Your Trials Compliant With The Updated Physician Payments Sunshine Act? 12/7/2023

    Sponsors must proactively mitigate Sunshine Act compliance risks by conducting thorough internal audits, reevaluating policies and procedures, and ensuring all financial interactions with healthcare providers align with legal and ethical standards.

  3. Developing A Diversity Action Plan That Actually Works 12/7/2023

    A successful diversity action plan (DAP) requires contributions of multiple cross-functional teams who are collectively well resourced and financed. Consultant Devra Densmore explains.

  4. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

    In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

  5. 3 Reasons Why Sponsors Must Review Monitoring Reports 12/5/2023

    Despite recent progress in executing and documenting oversight, sponsor oversight remains a challenge, especially with monitoring reports. Penelope Przekop detail three reasons why they must remain top of mind.

  6. How Planning For Failure Can Bring Patient Recruitment Success 12/4/2023

    To recruit patients successfully, it's actually worthwhile to first seek failure. Here, patient recruitment specialist Ross Jackson contends it's good practice for highlighting (and removing) bad practices.

  7. Rare Disease vs. Chronic Conditions: Recruitment And Engagement Strategies 12/1/2023

    Rare disease and chronic conditions, when it comes to studying their interventions in clinical trials, have similarities as well as differences — from protocol feasibility to patient recruitment and retention tactics. Consider the rare disease portfolio at Alexion Pharmaceuticals and chronic conditions in the AstraZeneca portfolio.

  8. Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply 11/30/2023

    While it is challenging to make precise predictions for clinical trial supplies, applying Bayesian statistics will help. This article shares steps to plan your Bayesian approach and how it helps to reduce waste and prevent shortages.

  9. Release Testing Of AAV Gene Therapies For Clinical Trials 11/29/2023

    Adeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency.

  10. Understanding Human Behavior To Help Improve Patient Adherence 11/29/2023

    In clinical trials, early dropout rate across all conditions still hovers around 30% and almost 70% of the protocol deviations are potentially linked to non-adherence. The BEAMER project, in part, sets to remedy that.