Clinical Trail Vanguard Newsletter August 1,2024
CONFERENCE COVERAGE
The 2024 DIA conference session on decentralized clinical trials (DCTs) brought together leading experts from various sectors to discuss the evolving landscape of clinical research. Chaired by Rasika Kalamegham, PhD, Head of U.S. Regulatory Policy at Genentech, the session featured insights from Jane Elizabeth Myles, MSc, Program Director at the Decentralized Trials and Research Alliance (DTRA); M. Khair ElZarrad, PhD, MPH, Director of the Office of Medical Policy at the FDA; and Dylan Bechtle, MS, Associate Director at Johnson & Johnson. The discussion highlighted the transformative potential of DCTs in making clinical research more patient-centric and efficient.
EXECUTIVE INTERVIEWS & ARTICLES
We had the chance to sit down with Harven DeShield, Chief Executive Officer and Co-founder of Vivacelle Bio. We explored Vivacelle’s new phase three study for the treatment of hypovolemia due to septic shock, focusing on the trial design, challenges, and innovative approaches that may revolutionize treatment.
In recent years, clinical trials have transformed with the rise of decentralized clinical trials (DCTs). This innovative approach leverages digital health technologies, remote monitoring, and telemedicine to conduct trials without the traditional reliance on centralized clinical sites. While DCTs offer numerous benefits such as augmented patient participation, diminished costs, and enhanced data collection, they also engender significant concerns about data privacy and regulatory compliance. In particular, to be approved in EU countries, DCTs must adhere to the stringent stipulations of the GDPR.
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CLINICAL TRIAL NEWS
Unlearn, an AI company, showcased the impact of its technology in two poster sessions at the Alzheimer’s Association International Conference. Their Digital Twin Generators create personalized forecasts of clinical outcomes for participants, enhancing the efficiency of clinical trials.
Groundbreaking research has led to a novel model using human induced pluripotent stem cell (iPSC)-derived cortical neurons to understand Alzheimer’s disease (AD). This model accurately reproduces key aspects of aging in a microphysiological system, offering a valuable tool for drug discovery and disease study.
An interim analysis of the AMPLIFY Phase III trial has revealed encouraging results in the treatment of chronic lymphocytic leukemia (CLL) with AstraZeneca’s CALQUENCE? (acalabrutinib). The combination of CALQUENCE with venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) compared to standard chemotherapy in previously untreated patients.