Protocol Design Featured Articles

81. Dedicated Trialist, Nurse Navigators Help Advance Cancer Therapy Into Accelerated Approval 9/11/2024

    Thoracic medical oncologist Sally Lau, MD Lau discusses her role as a principal investigator, from the benefits of the FDA’s accelerated approval pathway to best practices for retaining a challenging patient population.

82. Which Top HEOR Trends Will Have The Biggest Impact On Clinical Research? 9/6/2024

    ISPOR CEO Rob Abbott discusses Health Economics and Outcomes Research (HEOR) trends and how they're impacting clinical trials. 

83. More Diverse Enrollment Means More Attention To I/E Language 9/4/2024

    Clinical research nurse Teri Crumb, MSN, RN, CCRC picks out a few potentially problematic inclusion/exclusion (I/E) criteria and details ways to address them.

84. 3 Surefire Ways To Design Trials That Patients Want And Need 9/3/2024

     

    Alpha Tau Medical CMO Robert Den, MD details three ways sponsors can more effectively design clinical trials with patients in mind.

     

85. A Vision For Inclusion: Designing Trials That Benefit Visually Impaired Patients 8/30/2024

    Ocugen CMO Huma Qamar, MD, MPH, CMI contends that whether targeting vision-related conditions or other medical needs, sponsors must design trials that ensure vision-impaired patients are included.

86. The DCT Revolution Is Over… Vive La DCT Evolution! 8/29/2024

    The DCT ecosystem has matured significantly to include service providers with more real-world experience and advanced tools, plus a mindset of initiative versus reaction. Numerous regulators have released or updated DCT guidance documents in recent years, too, putting the onus on the industry to provide actionable feedback on those drafts.

87. These 3 Areas Need Risk Management Attention Now 8/29/2024

    Consultant Jessica Cordes and medical affairs expert Oscar Segurado team up to discuss the three key areas of risk in clinical trials.

88. Summing Up The FDA's Long-Anticipated Draft Guidance On Diversity Action Plans 8/26/2024

    Life sciences attorney Marylana Saadeh Helou summarizes the FDA's draft guidance on Diversity Action Plans (DAPs).

89. Changing Trial Design When Stepping Up From Second-Line To First-Line Treatment 8/20/2024

    Chief Medical Officer Fairooz F. Kabbinavar, MD, FACP, explains how Cardiff Oncology moved its CRDF-004 into a first-line treatment and how conversations with consultants and the FDA made it possible.

90. Operationalizing A Diversity Action Plan That Makes An Impact 8/19/2024

    In part two of this series on creating a diversity action plan (DAP), Elevate Advocacy's Devra Densmore shares a detailed plan for creating a DAP that meets FDA expectations.