Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
Delcath Systems Inc.’s decision to overhaul the ongoing Phase III study for its melphalan chemosaturation system could get the company closer to resubmitting a new drug application in 2019 but also brings with it considerable regulatory risk.
The company announced July 27 that it is reducing by two-thirds the size of the FOCUS trial in patients with...
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
