In biopharma there’s an initiative called patient centricity. The software-ish explanation would be the UX and CX of a clinical trial.
Given the expense and waste of resources that the industry says it wants to address, the idea of building a trial that patients actually want to participate in should be a no-brainer. Biopharma has a long hx of problems with recruiting, retention, and adherence to clinical trial programs. You would think that any startup biopharma would instinctively set off with a comprehensive patient-centric approach.
But waterfalls are so pretty and relaxing.
The majority of trials continue to pursue a complex waterfall approach rife with multiple sites, multiple endpoints, multiple outsourcing partners, etc…
The thing is, a startup biopharma only has funding coming in because it does not yet have an approved product to sell. Given this, I think many of the questions posed above actually have little impact because the company does not really have anything beyond funding.
There’s the whole patent expiration period but we lose sight of the fact that a patent is just a piece of paper without patients.
Getting back to the idea of patient centricity. If an org truly wanted to build patient-centric foundational thinking, it would challenge itself to pull the andon cord when strategy starts defaulting to multiple sites and multiple endpoints or partnering up with a fifth service provider.
In truth, much of drug development could be described as artifact-centric, thus the value question is one I think about every day. There are artifacts created to track artifacts.
For me, it would be about finding ways to spend the only thing the biopharma startup has, funding, more wisely…incrementally through an agile-like methodology adopted to clinical trial development.
Trial teams would be empowered to pull the andon cord in strategy discussions the moment someone suggests something that extends the iterative cycle or adds complexity that has not been requested directly by a patient through interviews.
What I’m finding is that patient centricity discussions focus mostly on the software that will make the patient experience more amenable. The core issue is that clinical trial teams need fundamental behavioral change if patient centricity has any hope of becoming the new way forward. Behavioral change needs a system. I believe that system is agile / lean startup.