• EMA Endorses Biomarkers For Type 1 Diabetes Prevention Trials

    Clinical Research News | Following many years of collaborative patient-level data sharing across stakeholder groups, the European Medicines Agency (EMA) recently endorsed pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) trials focused on delaying or preventing the disease. The Qualification Opinion appears on both the EMA website and that of the Critical Path Institute’s (C-Path) Type 1 Diabetes Consortium (T1DC).

    Apr 8, 2022

  • Building Clinical Trial Infrastructure for Greater Diversity

    Clinical Research News | The life sciences industry has faced recent criticism for its continued challenge to boost diversity in clinical trials. Reports suggest that the US Food and Drug Administration (FDA) is currently at work on guidance that will define how the agency would interpret “adequate representation” of ethnic, racial and age diversity to increase representation of traditionally underrepresented populations in drug development. This will ensure organizations are broadening eligibility criteria through inclusive trial practices and trial design.

    Apr 8, 2022

  • Matching Japan’s Real-World Databases To Research Purposes

    Clinical Research News | Japan has a variety of databases available to researchers, but knowledge and experience is needed to understand the characteristics of each one and select wisely, according to two representatives of CMIC Group, the country’s largest contract research organization. The database options are tied to Japan’s publicly funded healthcare system that provides universal health insurance and the freedom to choose among medical institutions offering consistently high-quality, low-cost medical care.

    Apr 7, 2022

  • The Scope of Things: Craig Lipset on Decentralized Trials, the New Risk Model, and Open Doors

    Clinical Research News | The pandemic has certainly been a turning point for decentralized trials, and Craig Lipset, co-chair of the Decentralized Trials and Research Alliance (DTRA) says the reasons are clear: the industry’s understanding of risk.

    Apr 5, 2022

  • Follow the Money: Clinical Effectiveness Studies in Urinary Incontinence, Sickle Cell Disease, Mental Health

    Clinical Research News | Funding of clinical effectiveness studies related to urinary incontinence, sickle cell disease, mental health, and hypertension management, a new gene therapy for atrial fibrillation, and funding for cloud-based clinical data analytics.

    Mar 31, 2022

  • Orphan Drug Designation for ALS Treatment, Virtual Assistants in Genetic Counseling, Clinical Research Expansion in Asia

    Clinical Research News | New orphan drug designation for ALS treatment, virtual assistants in genetic counseling, AI in healthcare professional engagement, AI-powered pathology for clinical diagnostics, clinical research expansion in Asia, more.

    Mar 30, 2022