The ethical concerns surrounding the non-disclosure of genetic risks to participants in Alzheimer’s anti-amyloid drug trials have sparked significant debate. Eisai and Eli Lilly, the companies conducting these trials, were aware of the increased risk of brain swelling and bleeding in participants
The University of Chicago Medicine (UChicago Medicine) has initiated a Phase 2 clinical trial to explore the potential of CAR T-cell therapy in treating three challenging autoimmune diseases: systemic lupus erythematosus, inflammatory myositis, and systemic sclerosis. CAR T-cell therapy, originally
Recently, concerns have been raised by Clinical Safety Officers (CSOs) regarding the potential risks to patient safety due to NHS trusts' historical non-compliance with digital clinical safety standards. A BBC investigation revealed that 126 cases of serious harm, including three fatalities, were
The intersection of artificial intelligence (AI) and bioprocess development has paved the way for groundbreaking advancements in the life sciences sector. One particularly exciting development in this domain is the collaboration between Eppendorf SE, a leading life sciences company, and DataHow AG,
Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine, providing the highest level of evidence for the efficacy and safety of new drugs and medical devices. However, traditional RCTs often face significant challenges, including high costs, complex governance, and
The subject of this article is the significant strides made in genetic research that have led to the diagnosis of over 500 European patients with rare and previously undiagnosed conditions. This includes uncovering the roots of rare neurological disorders, severe intellectual disabilities, muscle