Patient-Centric Feasibility Checklist

I hate the word “patient-centric”. It reminds me of the time I had these meetings with pharma companies where we were discussing patient recruitment challenges and patients’ needs, not really diving into the actual problems and interactions between patients and clinical trials. 

It also reminds me of the countless number of articles and conferences where we discuss how important it is to bring the patient in the center and then most of these words get lost in the day-to-day habits and activities we all have to prioritize.

Yet, I am using “patient-centric feasibility” as the definition of the checklist I decided to create for you in order to support your efforts towards more successful feasibility studies and clinical trial strategies

Most of you who have been following me know that my team and I are working on supporting companies planning their next clinical trials. In the last 2 years, we’ve backed up their decision-making process with data and country-specific insights for over 1000 clinical trials. And coming from a patient-dedicated platform background, we made sure we embed our experience working with patients in one way or another.

The growing number of studies, which feasibility process we supported, validated fully a rhetorical question I had:

If we are to put the patient in the center of a clinical trial, why aren’t we doing this from the very beginning of the study, even at the planning stage?

So, here I am, creating this checklist for you that will help everyone out there who wants to go beyond traditional feasibility and lead the way to patient-centric feasibility.

First things first: What is “patient-centric feasibility”? 

Feasibility as a word is used in many industries but in clinical trials, it is related to two main things:

  • Competitive/ landscape analysis 
  • Site feasibility / Site surveying

In both cases, the main question to answer is how likely am I to recruit patients on time and budget. These two tasks (landscape analysis and site surveying) are a must-have (though with fully decentralized trials we can argue about that) and yet after years of repeating the 2 steps we know one thing: They are not enough. So what’s missing?

In the consumer business, there is one thing called referral partners. It is a common strategy to partner with a referral partner to acquire more clients. In this case you ask your referral partners how many clients they could possibly connect you with. At the same time, you also do your homework by asking: What do I bring to my clients in the first place? 

In the clinical research space, due to regulations and processes, sponsors can not go and recruit patients without the investigators. So, basically, they have to 100% rely on their “referral partners”. This is why often they focus their questions and research on what the investigators want and not necessarily what the patient wants. By the way, you can check out one of my latest articles about the missing questions in a site survey.

Being able to address not only how the site can recruit patients, but also what it will take for patients to sign up for the study and be engaged the whole time is what we call patient-centric feasibility.

As mentioned above, I have put together a checklist of questions you should ask every time you think about a new clinical trial. You can download this checklist here (no email needed!) and apply it to every clinical trial strategy you design.

If you are missing any country-specific intelligence, especially on the patient diagnosing and treatment pathways, make sure you visit our website and/or contact us. We will be happy to assist with any urgent case you have and show you how you can embed the patient-centric feasibility approach into your team and processes.

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