Considering tomorrow’s patients in today’s drug approvals

Responding to pressure from patients seeking access to promising new medicines,1 drug regulatory agencies have worked over several decades to adopt more patient centred approaches.234567 The decision whether to approve a drug reflects both scientific evidence and value judgments about the sufficiency of that evidence.8 Patient centred drug regulation recognises patients as experts in their conditions and aims to incorporate their experiences, needs, and preferences when making decisions that demand balancing benefits and risks, speed and certainty.9 Because patients are directly affected by drug approvals, especially when they face serious diseases and conditions that lack good treatment options, it is an ethical imperative that they have a seat at the regulatory table, with the opportunity to have their voices heard in decisions about which drugs should be allowed to come to market and how they should be studied.1011A relatively unrecognised but persistent challenge, however, is that tomorrow’s patients—those who are…
Read Original Article: Considering tomorrow’s patients in today’s drug approvals »