What makes a compliant Phase III and pre-launch patient advocacy strategy?

摘要

BackgroundA key task for the pharmaceutical industry is to understand the compliance implications of engaging with a patient advocacy group (PAG). This presents challenges for the industry to negotiate the ethical and reputational issues that can arise when working with a PAG.ObjectiveTo gain the views of pharmaceutical industry executives on future compliance challenges when working with PAGs.Study designWe conducted two surveys among two sets of industry executives: one group focussed on market access roles and the other focussed on non-market access roles.ResultsTransparency was identified as the biggest challenge, followed by project rationale and then by project ownership.ConclusionWe explore how this can be overcome and make recommendations on how best to work compliantly with PAGs.