ACT Brief: Support Services and Cancer Trial Access, 2025’s Most-Watched ACT Video Interviews, and FDA Approval of Narsoplimab

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In a new ACT video interview, Shanthi Sivendran, MD, MSCR, MBA, senior vice president for cancer care support at the American Cancer Society, discussed data from its cancer care support program which show that logistical and financial barriers remain a major obstacle to cancer trial participation. Between late February and late November, more than 1,300 patients, caregivers, and healthcare professionals across the US contacted the program, collectively identifying nearly 2,500 individual barriers to care or trial access. The most frequently reported challenges included financial strain, transportation, lodging, and emotional burden during cancer treatment.
• ACT has released its list of the five most-viewed video interviews of 2025, reflecting key pressures facing the research ecosystem. Top interviews addressed the impact of NIH funding cuts on academic research infrastructure, legal and political implications of the NIH funding freeze, rising API tariffs affecting R&D and supply chains, strategies for improving sponsor–site collaboration, and the role of leadership in navigating regulatory and funding uncertainty. Together, the interviews highlighted funding volatility, policy shifts, and operational strain across clinical research.
• The FDA has approved narsoplimab for adults and children aged two years and older with hematopoietic stem cell transplant–associated thrombotic microangiopathy, based on results from a single-arm, open-label TA-TMA study and expanded access data. In the pivotal study, narsoplimab achieved a TMA complete response rate of 61% in evaluable adult patients, with supporting response rates of 68% observed in expanded access patients. Across studies, improvements were seen in platelet counts, LDH levels, organ function, and transfusion independence, with a 100-day survival rate of approximately 73%.

That’s all for today’s ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.