Even though randomized controlled clinical trials(RCTs)have been accepted as the gold standard for official assessment of novel interventions,there is a substantial gap between the efficacy observed in RCTs and the im...Even though randomized controlled clinical trials(RCTs)have been accepted as the gold standard for official assessment of novel interventions,there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in terms of patient benefit.While real-world studies(RWS)are emerging to confer valuable complementing evidence in this regard and beyond,the evolving role of RWS is yet to be agreed.This article delineates an updated profile of RWS covering effectiveness verification,rare adverse effects discovery,indication repurposing,to name a few.RWS tends not only to improve the efficiency of clinical investigations for regulatory approval,but also optimizes the whole-life cycle evaluation of biomedical/pharmaceutical products.展开更多
文摘Even though randomized controlled clinical trials(RCTs)have been accepted as the gold standard for official assessment of novel interventions,there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in terms of patient benefit.While real-world studies(RWS)are emerging to confer valuable complementing evidence in this regard and beyond,the evolving role of RWS is yet to be agreed.This article delineates an updated profile of RWS covering effectiveness verification,rare adverse effects discovery,indication repurposing,to name a few.RWS tends not only to improve the efficiency of clinical investigations for regulatory approval,but also optimizes the whole-life cycle evaluation of biomedical/pharmaceutical products.
