what’s on your checklist for success? how do you define successful phase iii, iv or observational...
TRANSCRIPT
What’s on Your Checklist for Success?
HOW DO YOU DEFINE SUCCESSFUL PHASE III, IV OR OBSERVATIONAL STUDIES? WHEN DO YOU INCLUDE KEY STAKEHOLDERS?
OCTOBER 20, 2014
Who are we?Cultivate Value, Advocacy and Collaborations
(Terrie)
Market Access and Cost-Effectiveness
(Julia)
Role of EMRs in registry and post-marketing studies
(David)
Amy collaborates with all three (3)
What is Success?
Patient
Healthcare Providers
Pharma
Hospitals
Payers
Pharmacists
Policy Makers
Improved communication
Enhanced engagement
Building better Partnerships Development and support of products patients need
and want
When do you engage provider groups or integrated healthcare systems in these studies?
What type(s) of groups do you consider primary targets? Why?
Do you engage patients? Patient advocacy groups? When are ideal times to engage them?
What’s on your checklist for Success?
Top 3 “Must have’s” Top 3 “Don’t need” Top 3 “Impede success”
Take-aways There are processes to follow that enable you to be successful in your Phase III, Phase IV or Observational Studies and a checklist can be a part of that. However, as Atul Gawande has said before:
“Checklists are not hard and fast rules to live by; they are guidelines to help us make sense of the complexity of our lives."
BUT…There isn’t a “one-size fits all” solution
AND…You can’t go it alone – you are in this together