In a previous blog post (Linked here), I raised the issue of patient-centricity and my concern that it is being used more as a marketing tool than a way to build truly patient-centric products. To shift that thinking, there needs to be broad commitment to bringing patients into the fold at every stage of the development process.
Have patient advocates come into the company periodically to talk to the whole team – from the chief executive officer and chief financial officer to the clinical research associates, regulatory personnel and others involved in the development of the product. Get the patient to explain how the disease affects their life and what their wants and needs are. How can you design a product and put it on the market if you don’t truly understand your customer?
The fact is that those of us in this business aren’t here primarily to make money: we’re in medical research to help bring treatment to patients who need them. So, bring them in. Have them speak to your partners in the clinical research process so we can hear from patients or their carers – even if it’s by video or webinar – what they need and what their main challenges are. In so doing, it would help clinical research organisations and others to design studies better, build recruitment plans around the needs of those patients, and establish better compliance endpoints, because trials would be designed in a way that supports the needs of patients.
While discussions with patients may well be happening in the background, if everyone involved in the clinical design process doesn’t hear and can’t contribute to them, we can’t build products and protocols that meet the needs of patients.
When that starts to happen, studies will become more patient-centric and endpoints will be geared towards the needs and concerns of patients. And when that occurs, the authorities are more likely to not only be more open to approving a product, but also to reimbursing it.