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1、New Medicines,Novel Insights:Achieving Patient-Guided Drug DevelopmentAn Executive Summary2|NEW MEDICINES,NOVEL INSIGHTS:ACHIEVING PATIENT-GUIDED DRUG DEVELOPMENTIn this reportIntegrated Development 4Patient-Relevant Clinical Outcome Assessments 8Advancing PRO Data 123|NEW MEDICINES,NOVEL INSIGHTS:A

2、CHIEVING PATIENT-GUIDED DRUG DEVELOPMENTBest practices for patient-focused drug developmentIn drug development,the natural tendency has long been to prioritize the science of treatment over patient access and engagement.Yet,while research and development are foundational to our profession,it is the

3、patient who is our ultimate consumer.At Parexel,we have clearly determined the need to reverse this equation:that addressing the concerns patients care most about is essential to commercial success in a complex and competitive market.Moreover,the U.S.Federal Drug Administration(FDA)has prioritized p

4、atient-guided drug development,issuing four guidance documents over the last four years.1However,a patient-guided approach might sound more like an aspiration than an achievable goal.How can drug developers listen,learn,and incorporate the patients voice in a multifaceted process involving so many d

5、ifferent stakeholders?What does it really mean to be patient-guided?In this report,we share best practices to illustrate how companies can infuse a thorough embrace of patient centricity throughout the many interconnected processes along the journey.We have seen that sponsors can make a dramatic dif

6、ference in their development programs by involving patients in a sustained,systematic way throughout the development continuum.In every therapeutic area,patients are increasingly being recognized as critical stakeholders for product evaluation and should be engaged early and often.This approach begi