I’m here to tell you that you might think your pivotal trials have only one primary endpoint, but there is a co-primary endpoint that you’re not even aware of. You won’t find it on the FDA’s website, but if you’ve done any research with physicians recently it’s starting to surface, despite the fact that few physicians verbalize it to sales representatives. What is this invisible endpoint?
Your co-primary endpoint is Physician Quality of Life and it’s not synonymous with convenience. The components are much broader than that but can generally be lumped into two broad categories:
- Clinical Barriers:
- What % of patients respond to therapy?
- How long do they respond to therapy?
- What % of patients can tolerate the recommended dose versus those requiring dose adjustment?
- Is the product easy to administer? Does it require staff time?
- Does the adherence rate from the clinical trial hold up in the real world?
- Non-Clinical Barriers:
- Can patients acquire the drug at the local pharmacy?
- How much staff time is necessary to ensure that prescriptions are successfully adjudicated?
- What arrangements have been made with foundations to address gaps in the healthcare system?
You can choose to ignore PQOL or you can start to incorporate it into your key performance indictors prior to and during your launch.
We’re all looking to enhance our differentiation strategy, and improving PQOL through use of your product and associated services deserves careful consideration.