As stakeholders across clinical development as well as healthcare providers increasingly embrace measurements of health outside the clinic, it is becoming increasingly critical to incorporate person-generated health data (PGHD) into clinical research and development programs. Given the novelty of PGHD, healthcare systems also must determine how best to mobilize around PGHD and initiate relevant research. A joint FDA-industry meeting identified five key takeaways for organizations seeking to implement the use of PGHD to enhance their clinical product development programs: provide value to research participants, use evidence-based study designs, apply proven tools from traditional clinical research when appropriate, leverage PGHD to identify what matters most to participants, and deploy PGHD methods to identify gaps in knowledge obtained from clinical trials. In this report, we describe and expand on these ideas and draw inspiration from real-word examples that demonstrate the potential of PGHD.
As stakeholders across clinical development as well as healthcare providers increasingly embrace measurements of health outside the clinic, it is becoming increasingly critical to incorporate person-generated health data (PGHD) into clinical research and development programs. Given the novelty of PGHD, healthcare systems also must determine how best to mobilize around PGHD and initiate relevant research. A joint FDA-industry meeting identified five key takeaways for organizations seeking to implement the use of PGHD to enhance their clinical product development programs: provide value to research participants, use evidence-based study designs, apply proven tools from traditional clinical research when appropriate, leverage PGHD to identify what matters most to participants, and deploy PGHD methods to identify gaps in knowledge obtained from clinical trials. In this report, we describe and expand on these ideas and draw inspiration from real-word examples that demonstrate the potential of PGHD.