Innovation in Clinical Trial Design and Product Promotion: Evolving the Patient Perspective With Regulatory and Technological Advances.

Abstract

Clinical trials are evolving to innovative designs and capabilities. Clinical outcomes from pivotal trials are the backbone of good marketing practices. Novel study designs included in product labels and the uptick of innovative technology foreshadow a crescendo of patient empowerment not only in clinical trials, but also in the real-world setting. The following review will initially explore the dynamic relationship between clinical development and commercial teams. How clinical development is evolving to increase patient-focused drug development and regulatory review will then be reviewed via recent legislation; the 21st Century Cures Act is one glimpse at innovative inclusion of the patient perspective via patient experience data, related information, and real-world evidence. Trends in direct-to-consumer technology such as digital health will be also appraised. Predictions are made on how the aforementioned advances may create challenges and opportunities to promotional practices, including crosscollaboration of marketing teams and planning for the next level of patient empowerment. Finally, a hypothetical scenario is provided to illustrate marketing/commercial dynamics when planning for and promoting data from an innovative trial design with real-world evidence.