What’s so hard about patient centricity in clinical trials?

There’s a lot of talk about customer centricity and patient centricity in the pharma industry these days.  The discussion extends to drug development and clinical trials.

This started a few years ago, as we realized that our clinical trials were getting more and more difficult for patients due to the number of assessments and the grueling schedule often required of study participants.  To lower the barriers to participation, we look for ways to incorporate the patient’s viewpoint into study designs, and to make study participation less burdensome and time consuming.

These efforts should really be applauded.  Any effort that makes study participation significantly easier for patients, their families and caregivers is worthwhile.  But so far, the gains have been modest.  Why is that?

Years ago while teaching service management courses, I came across a great thought question:  What would a hotel look like if it were built for the ease of support departments like housekeeping, catering and security?  Answer: it would look like a hospital, and not a particularly nice one at that!  Anyone who’s had great service in a hotel will appreciate how those support departments can be orchestrated to create a first-rate and seamless customer experience.

Currently, clinical trials are definitely not built around the patient.  Sites will assure you that they are also not built around study coordinators, clinics or Investigators.  They are mostly built around the trial’s schedule of assessments, and it’s up to the study coordinator and other clinic staff to bring it all together.

Why is it so difficult for us to re-think study participation so it’s built more around patients and their caregivers?

The demands of organizing and managing studies are significant and getting worse.  The biopharma company’s clinical scientist is under pressure to design the study around valid endpoints that will lead to approval, or at least to a significant advancement of our understanding of the disease or treatment.  It’s difficult for biopharma study managers and procurement departments to identify, qualify and contract with the many technical vendors (sometimes dozens) needed.  All of these challenges need to be met under strict time pressure.

Given these challenges, it’s not surprising that patient-centricity has not yet been addressed.  In addition biopharma sponsors and CROs have lacked the internal expertise to address the re-engineering that may be required.  But patient centricity remains a frontier that the clinical trials enterprise really needs to conquer.

Addressing this won’t be simple, but it’s not impossible.  The ability to put the customer in the center of designing a service experience can definitely differentiate a great provider from the pack.  Returning to my comparison, most of us have had many more mediocre or terrible hotel service experiences than terrific ones.

This will require sponsors to re-think the study journey through the eyes of the patient and the study site.  It’s an exercise that won’t happen accidentally, but it can begin when study assessments are being finalized and most vendors have been identified.

The roadmap to achieve this includes three steps which should be considered imperatives for all clinical trials:

1. Ensure the study assessments represent the simplest study you can conduct to achieve your objective. Remember that each procedure is more than a tick mark in a table – it also represents cost, logistical challenges and a real patient doing their best to complete your trial
2. Take time to understand the patient’s journey through the clinic and what the experience of participating in the study would look like. How many times will they need to move from one assessment to another, and how long will it all take?
3. Understand what the site’s challenge will look like. If your study requires several technical vendors, how can you ensure you know how they all work together, before it becomes the site’s problem to work it out?

Each of these requires time, a small amount of expertise and consultation with experts, but the result will be worthwhile.  Not only will you know that the individual project is more attractive to patients and investigative sites, but it will also build your reputation as an empathetic sponsor who thinks differently.