Drug development is driven by a need to generate revenue. While effective marketing is essential to success, its role continues to be a secondary consideration in the developmental process. To cite an example, fecal lactoferrin and fecal calprotectin are two biomarkers developed for inflammatory bowel disease, but the tests are often not covered by insurance and do little to guide treatment decisions. In another instance, endpoints for endoscopic healing—seen as key in controlling IBD—are often measured during trials in a way that is foreign to rank-and-file clinicians.
As data trickle out, manufacturers develop strategies about how to market the drug. From projected endpoints, marketers hope to make their drug compelling to end-users. They are limited by the data.
Early marketing involvement in the clinical program can give a customer perspective that is vital to a clinical program's design via marketing research before and during clinical trials, marketers can help R&D address end-user needs and be financially savvy. Clinical trial features that can be informed by early marketing research include:
• Demonstrating clinical need: Is there a need? How can it be addressed in a compelling way?
• Patient selection criteria: For what types of patients is there an unmet need?
• Competitive set: What competitors comprise the current/future standard-of-care?
• Clinical endpoints: What endpoints are applicable to a clinician's decisions?
• Validation criteria: What types of validations are required by end-users?
• Cultural relevance: How will divergent end-users apply results to their specific cultural needs?
John Taenzler is principal, Evolution Marketing Research.