
Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
In an interview with ACT senior editor Andy Studna at the 2025 DIA Global Annual Meeting, Carie Pierce, SVP, global head of growth & business development, DIA, reflects on the importance of leadership to drive progress in clinical research amid evolving regulatory and funding challenges.
As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.
Peter Ronco, CEO, Emmes, explains how public sector leaders are driving innovation in clinical development through automation, long-term data utilization, and experimental trial design—despite the private sector dominating the conversation around artificial intelligence.
In an interview with ACT senior editor Andy Studna at the 2025 DIA Global Annual Meeting, Carie Pierce, SVP, global head of growth & business development, DIA, shares her perspective on the progress of international regulatory initiatives like Project Orbis and highlights the industry’s renewed focus on scientific integrity amid global challenges.
Using a recent survey on the adoption of AI/ML conducted by the Tufts CSDD as context, pharma leaders discussed how they are using these technologies to optimize trial execution.
In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), shares his perspective on how clinical operations teams can evolve through patient-centered trial design, multi-disciplinary support, and enhanced education to address persistent barriers in cancer trial enrollment over the next five years.
In an interview with ACT senior editor Andy Studna at the 2025 DIA Global Annual Meeting, Carie Pierce, SVP, global head of growth & business development, DIA, discusses the growing emphasis on meaningful patient inclusion in clinical trial design and the importance of cross-sector collaboration to drive innovation in the clinical research ecosystem.
Global R&D leaders discuss the need for collaboration in medical research and how regulatory agencies are working to create the proper environment for advancements.
In this Q&A, Megan Bailey, EVP and president of central laboratories and international, Labcorp, discusses how central labs are evolving beyond testing to become strategic partners in clinical trial success.
In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), explores how emerging technologies such as wearable devices, real-world data analysis, and decentralized trial designs can improve the identification and engagement of potential cancer clinical trial participants.
New data from the POETYK PsA-Phase III trial, presented at the 2025 EULAR Congress, demonstrate that Bristol Myers Squibb’s Sotyktu (deucravacitinib) significantly improves joint and skin symptoms in adults with active psoriatic arthritis, maintaining efficacy through 52 weeks of treatment.
In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), highlights the importance of equipping site staff and caregivers with tools and best practices to effectively communicate clinical trial opportunities to patients and improve enrollment rates.
Clinical research evolves to prioritize patient-centered outcomes, integrating accessibility standards in electronic data capture for inclusive clinical trials.
Exploring stat-based testing for variables that identify deliberate data manipulation in clinical trials.
In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), shares insights on the complex barriers limiting cancer patient participation in clinical trials and explores potential strategies for improving access and diversity.
Overcoming the illusion of knowledge in clinical research can enhance decision-making, training, and project success—helping ensure trials run smoothly and effectively.
Data from the Phase IIIb APEX study, presented at EULAR 2025, show that guselkumab (Tremfya) improved joint and skin symptoms and inhibited structural joint damage in patients with active psoriatic arthritis, reinforcing its role as a leading IL-23 inhibitor for long-term disease control.
In this video interview, Matt Robinson, PhD, senior director, oncology research program, National Comprehensive Cancer Network (NCCN), discusses the persistent challenges of low cancer patient enrollment in clinical trials and why broader participation is critical for advancing oncology research.
In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
Phase III DeLLphi-304 results show T-cell engager Imdelltra (tarlatamab) delivers superior overall survival, improved progression-free survival, and better symptom control compared to chemotherapy in patients with small-cell lung cancer following platinum-based treatment.
In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses how key stakeholders in clinical research are responding to uncertainty with budget cuts and administrative shifts.
As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.
Phase II CONFIDENCE study data reveal that simultaneous initiation of Kerendia and Jardiance significantly improves UACR and delays chronic kidney disease progression in patients with type 2 diabetes.
In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses the need for more data and education on multisite clinical research corporations before adoption can become more widespread.
In the Phase III VISIONARY study, sibeprenlimab, an investigational monoclonal antibody, showed a 51.2% reduction in proteinuria at nine months of treatment.
New data from the IRAKLIA and IZALCO trials, presented at the 2025 ASCO Annual Meeting, demonstrate that subcutaneous Sarclisa delivered via an on-body delivery system offers non-inferior efficacy to IV infusion in patients with relapsed or refractory multiple myeloma, while significantly reducing infusion-related reactions and improving patient satisfaction.
In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), talks multisite clinical research corporations and how they can streamline clinical operations.
Results from the Phase Ib/II CARTITUDE-1 trial demonstrated that a single infusion of Carvykti delivered durable, treatment-free remissions for at least five years in a third of patients with relapsed or refractory multiple myeloma.
Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.