A systematic review of models of patient engagement in the development and life cycle management of medicines.

There is currently no universally agreed code of practice for patient engagement (PE), and existing guidelines do not fully cover the scope across medicine development and subsequent life cycle management. This review conceptualises the meaning and summarises the current models of PE. A systematic literature review was conducted and analysed by thematic synthesis.

The Central Role of Ethics in Medical Affairs Practice.

The author argues that notwithstanding available guidelines and established practices, the elaboration of a formal ethics framework specific to medical affairs could improve good practice internationally. He further argues that further and better insights into the theory behind the practice of medical affairs are an essential precondition for elaborating any such framework.

Are the Current Processes and Regulations Fit for Purpose to Deliver Novel Therapies During Pandemics? A Perspective on COVID-19 from the UK.

The COVID-19 pandemic was the first 'stress test' to assess whether the current regulations in the United Kingdom (UK) are fit for purpose to develop novel therapies during pandemics. It saw innovations and collaborations across the spectrum of the drug development and regulatory pathways, including extraordinary collaborations between the various stakeholders involved in the process, the repositioning of medicines, the deployment of multi-arm, multi-interventional adaptive trials, the institution of operational simplicity and flexibility across various trial activities, and regulatory innovations. The question arises whether the innovative flexibilities and the urgency that were instituted could have resulted in compromises to the integrity of the process.