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