GUEST COLUMNISTS

• Dedicated Trialist, Nurse Navigators Help Advance Cancer Therapy Into Accelerated Approval

  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.

• 4 Steps To Help Sponsors Return Individual Patient Data

  In part two of this series on individual patient data return (iPDR), Legacy Health Strategies experts offer four steps to help sponsors make iPDR a reality.

• Returning Individual Trial Data To Patients: How And Why It Needs To Happen

  Returning individual data to clinical trial participants is seen by many as "the right thing to do." Yet, its uptake is lacking. Legacy Health Strategies experts discuss why it's so important and how it can be achieved in part one of this two-part series.

• Which Top HEOR Trends Will Have The Biggest Impact On Clinical Research?

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

• Pelage Embraces Diverse Patient Recruitment For Non-Hormonal Hair Loss Therapy

  Pelage Pharmaceuticals’ CMO Qing Yu Christina Weng, MD discusses how the company expanded criteria to include patients of all skin and hair types and incorporate decentralized elements in their trial design for a novel hair loss treatment.

• More Diverse Enrollment Means More Attention To I/E Language

  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.

• 3 Surefire Ways To Design Trials That Patients Want And Need

   

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

   

• A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries

  To find suppliers and partners for our clinical trial programs, we need to go beyond just selecting the best offer and then managing them. For virtual organizations in particular, we must strive to be the partner of choice.