FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain
To evaluate the long-term efficacy and tolerability of a representative extended-release (ER)/long-acting (LA) opioid in a 12-month placebo-controlled trial, FDA staff are considering an enriched enrollment randomized withdrawal (EERW) study design, they noted in a briefing document ahead of an advisory committee meeting. On Wednesday, the Anesthetic and Analgesic Drug Products Advisory Committee will consider […]
Cancer and the Heart; COVID and Dx Delays; Not the Same Old Accelerated Approval?
The European Society of Cardiology has launched a clinical trial to evaluate cardiac MRI during chemotherapy to prevent treatment-related heart failure in patients with cancer. A large retrospective study showed that patients with heart failure had a significantly increased risk of developing cancer. (ESC Heart Failure) The American Heart Association awarded $11 million in grants […]