title: What makes a compliant Phase III and pre-launch patient advocacy strategy?
abstract: BACKGROUND
  A 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.
  
  
  OBJECTIVE
  To gain the views of pharmaceutical industry executives on future compliance challenges when working with PAGs.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Transparency was identified as the biggest challenge, followed by project rationale and then by project ownership.
  
  
  CONCLUSIONS
  We explore how this can be overcome and make recommendations on how best to work compliantly with PAGs.
authors.affiliation: Commutateur Advocacy Communications, Paris, France.
authors.forename: Nick
authors.initials: N
authors.lastname: Hicks
authors.affiliation: Medical and Pharmaceutical Consultant, Leicester, UK.
authors.forename: Keith
authors.initials: K
authors.lastname: Allan
authors.affiliation: European Multiple Sclerosis Platform, Brussels, Belgium.
authors.forename: Christoph
authors.initials: C
authors.lastname: Thalheim
authors.affiliation: Paul Woods Compliance, Stockport, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Woods
keywords: compliance; ethics; patient advisory group; pharmaceutical industry; reputation; transparency