Key Steps Toward a Promotional Communications Strategy: Collaboration Best Practices for Teams Creating Promotional Materials and Regulatory Colleagues.

A promotional communications strategy is considered early in prescription medical product development by commercial disciplines (e.g., commercial/marketing) and informs promotional materials to key stakeholders such as healthcare providers and patients. Health economics and outcomes research (HEOR) is a scientific discipline that is also responsible for the generation of promotional materials to other key stakeholders such as payors. The overarching promotional strategy benefits from consistent partnerships with regulatory affairs colleagues, culminating in cost savings and patient-centric promotional materials. Yet there is a paucity of published content that details effective collaboration between promotional teams and regulatory colleagues prior to medical/legal/regulatory (MLR) review. The following review aims to showcase such organizational innovation from the perspective of teams developing promotional materials (i.e., commercial and HEOR). Behind-the-scenes marketing activities are described in relation to the following key steps that build the strategy's foundation: insight gathering from key stakeholders; sub-strategy development; tactic identification; and promotional message development. Integration of regulatory colleagues with teams developing promotional materials is imperative to accomplish these key steps prior to any MLR review. Finally, four themes in best practices for collaboration with regulatory colleagues are shared from the perspective of commercial disciplines and HEOR, alongside a real-world example for each: (1) Alignment of Strategies; (2) Shared Process & Tools; (3) Creative Problem-Solving; and (4) Culture of Connecting.

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

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.

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

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 cross-collaboration 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.