Newswise — January saw one of the worst clinical trial debacles in memory, when a healthy man volunteering for a Phase 1 study in France died of hemorrhagic brain lesions and four others were hospitalized within days of receiving an experimental drug for anxiety and chronic pain. The fiasco was the worst such incident since 2006, and prompted calls for greater transparency in clinical trials and earlier public identification of experimental compounds. But while the French National Agency for Medicines and Health Products Safety (ANSM) has launched an investigation into the incident and other agencies are considering a response, the company, Bial Pharmaceuticals of Portugal, has been slow to hand over its preclinical data, citing trade secrecy.
Experts suggest that the debacle could lead to new safety recommendations for first-in-human drug studies, but others worry it could slow recruitment into trials, already a problem for many Alzheimer’s studies. Madolyn Rogers investigates what chemists have been able to find out about this drug, what may have gone wrong in this trial, and what the consequences may be.
About UsFounded in 1996, Alzforum is a news and information resource website dedicated to helping researchers accelerate discovery and advance development of diagnostics and treatments for Alzheimer’s disease and related disorders.
Our site expands the traditional mode of scientific communication by reporting the latest scientific findings and industry news with insightful analysis that puts breaking news into context. We advance research by developing open-access databases of curated, highly specific scientific content to visualize and facilitate the exploration of complex data. Alzforum is a platform to disseminate the evolving knowledge around basic, translational, and clinical research in the field of AD.
Alzforum is supported by a team with backgrounds in science, journalism, information technology, design, and data science. Together with a distinguished Scientific Advisory Board, and the active participation of a global network of scientists, we strive to produce unbiased content to a rigorous editorial standard.
Alzforum is operated by the Biomedical Research Forum (BRF) LLC. BRF is a wholly owned subsidiary of FMR LLC. FMR LLC and its affiliates invest broadly in many companies, including life sciences and pharmaceutical companies.Alzforum does not endorse any specific product or scientific approach.
RSS