GUEST COLUMNISTS

CLINICAL TRIAL WHITE PAPERS

  • Navigating The FDA's Drug Supply Chain Security Act

    Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.

  • Consider India For Your Next HCC International Trial
    11/16/2023

    Assess the feasibility of India as a potential venue for HCC trials as well as its epidemiology, historical perceptions, and untapped potential for international clinical research opportunities.

  • Enhancing Clinical Trial Flexibility
    9/1/2025

    Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.

  • 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.

  • The Hidden Problem In Early Phase Oncology Trials
    9/23/2025

    Integrating patient-reported outcome measures (PROMs) can enable improved capture tolerability and optimize dosing decisions.

  • Patient-Reported Outcome In Oncology Clinical Trials
    4/17/2025

    As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care.

CLINICAL TRIAL APP NOTES & CASE STUDIES

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RECRUITMENT AND DIVERSITY

This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.

FOCUS ON PATIENTS