Marketing Pharmaceuticals 2016

There is an open question amongst the drug development industry about how and when to best interact with patient groups regarding clinical trials. This knowledge gap has the potential to delay the start of meaningful clinical trials or lead to the conduct of less efficient trials by not tapping into the patient resource. Complex legal, ethical and regulatory issues, and ill-defined expectations can lead to unproductive relationships and disparate or unanticipated outcomes. While key stakeholders have moved to create a more effective model for engagement between research sponsors, investigators, and patient groups, leading to better clinical trials, guidelines for best practices have not been shared across the industry. This session will explore opportunities for drug developers to engage with patient advocacy groups, provide an overview of the regulatory framework through which such engagement should be moderated, and explore case studies that highlight best practices for industry interactions and partnerships with these groups.