SECTION 2
Traditional clinical endpoints failed to accurately measure patient experiences and perceptions, but patient-reported outcomes (PRO) could help. Based on Parexel's analysis of FDA review documents, we offer three best practices to capture sound PRO data.
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Patient-guided drug development requires more than a 30-minute meeting with patient advocates or aspirational text on a website. It is a systematic approach that begins at the earliest stages of development and informs nearly every decision afterward. Our Office of the Patient helps sponsors make use of patient insights to navigate an increasingly complex reimbursement landscape, mitigate risks, and develop commercially viable products that deliver relevant patient benefits.