The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

More than a year after UK health technology assessment body NICE started offering scientific advice on designing patient preference studies, only two companies have sought guidance. NICE has also contributed to related projects that it hopes will increase the relevance of such studies in the context of an HTA appraisal.