The Food and Drug Administration's Oversight of Clinical Trials

Approval is based on results from the Phase III ASCEND trial, in which patients using the powder achieved freedom from pain by 2 hours post-treatment in 34.2% of migraine attacks.

In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.

Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.

In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.

We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data — and there are more data modalities — to draw from for biomedical research than ever before. However, the quantity, variance and speed of data generation outpaces researchers’ ability to effectively utilize it to reveal medical breakthroughs for those in need. The ability to analyze health data is critical in developing a precision health approach. By leveraging diverse data sources, researchers can determine the most effective actions for individuals and communities. However, current barriers to data access and collaboration hinder progress. To accelerate the pace of discovery, a solution is needed to close the gap between research and health care. This paper describes how Verily Workbench provides solutions for healthcare professionals and researchers to easily access and collaborate on data within an integrated analysis and governance framework. Workbench provides a community of researchers with the platform, data, and tools to solve the most pressing scientific challenge

In the Phase Ib Beamion LUNG-1 clinical trial, zongertinib, an investigational irreversible tyrosine kinase inhibitor, demonstrated a median duration of response of 14.1 months.