Focus on Patients

51. Pelage Embraces Diverse Patient Recruitment For Non-Hormonal Hair Loss Therapy 9/5/2024

    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.

52. 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.

53. 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.

     

54. 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.

55. The DEI Dilemma: Separate Teams Or Embedded Methods? 8/28/2024

    Denise Bronner, PH.D. examines the advantages and drawbacks of separate, dedicated DEI teams and diversity roles embedded across functional areas.

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 Summing Up The FDA's Long-Anticipated Draft Guidance On Diversity Action Plans 8/26/2024

    Life sciences attorney Marylana Saadeh Helou summarizes the FDA's draft guidance on Diversity Action Plans (DAPs).

57. Individual Participant Data Return Solutions And Strategies 8/22/2024

    Paula Boyles, external clinical trial data-sharing program lead for Pfizer and TransCelerate BioPharma member, shares the benefits of and strategies for individual patient data return (iPDR).

58. 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.

59. The Future Of MDMA-Assisted Therapy After FDA Rejection — Where Do We Go Now? 8/16/2024

    After the recent FDA rejection of MDMA-assisted therapy for PTSD, psychedelic drug developers and mental health experts alike are asking (and answering), "Where do we go now?"

60. Creating More Equitable Clinical Trials With Health Systems Science 8/15/2024

    Belmont University Center for Health Systems Science Chair Douglas P. Slakey, MD, MPH explains how using health systems science to inform clinical trial design, implementation, and interpretation is crucial for achieving more equitable and effective patient outcomes.