Innovative Drug European Associates

Less talk more action: Building real patient-centricity from trial design

Patient-engagement or patient-centricity is now widely spoken about, but it’s rarely brought into the process of product development early on. As a regulatory consultant, my role is to fulfil the objectives of our clients as I help them navigate the clinical trial approvals process and I strongly believe that this would be a good point to bring patient organisations into the discussion. Unfortunately, this isn’t something that I have seen very often.

This demonstrates a clear disparity with the goal and the reality of patient-centricity in the current drug development landscape. I believe that true patient-centricity comes back to ensuring good study design, with end points aimed at improving quality of life based on patient insights, and a product placed on the market that puts the customer, the patient, first. Having the patient involved during early regulatory discussions would be a true reflection of patient engagement, but these vital elements are typically missing during the design stage.

While strides are being made to improve the situation, sadly, patient-centricity is still all too often used as a marketing tool, and often in unethical ways. For example, if the National Institute for Health and Care Excellence (NICE) decides not to fund a product after it has received approval, we sometimes see companies riling up patient groups to lobby against that decision, encouraging them to write to their doctors, the press, or on social media, to demand access to a drug. To me, that’s using patients at the wrong end of the process and for the wrong reasons entirely, and it’s the kind of behaviour that gets called out time and again earning so-called ‘Big Pharma’ it’s bad reputation.

If a company is developing a product for a rare disease, for example, what they could be doing is bringing in patient advocates early on and asking what matters most to them. Which aspects of their disease do they wish they could overcome or manage better in order to improve their life? It could be something as simple as having fewer blood tests or being able to have these done from home, so they don’t have to visit their doctor so often. A simple change in formulation to make the product slower release might address an issue like that, not only improving the product for the patient, but the knock-on positive effects on study compliance and thus on the clinical data generated also seem a no-brainer.

By talking to patients from the outset, companies would be in the best position to create not only a study design with the most relevant end points, schedule and logistics, but deliver a product (from formulation, to dose schedule, to packaging, and more) based on meaningful quality of life considerations. That would be true patient-centricity.

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