Patient-centred drug development: how far have we come, and what’s next?

Putting the patient at the centre of clinical development’. Easy to say, but over recent years industry has discovered it’s much harder to deliver.

Many now ask for patient perspectives – a great first step, but the real challenge is to truly embed this perspective in our programmes, in a way that both influences operational strategy and supports patient outcomes. What is standing in our way of doing this more effectively? We’ve picked our top three obstacles below:

Patient insights should be part of our planning at the earliest possible point. Even at target product profile stage, patient perspectives are invaluable for defining current and future unmet needs within a therapeutic landscape and showing where we can truly add value – in turn leading to more economical and patient-friendly future development phases.

We should seek patient opinion early on our study concepts, designs, endpoints and expected outcomes. Doing this before our protocols are ‘almost final’ genuinely allows us to incorporate the patient perspective, rather than simply seeking endorsement of a rigid plan.

We can learn a huge amount by inviting patients to tell us what matters to them. Encouraging them to challenge us, to ask us ‘why does it have to be that way?’ and exploring whether we can do things differently. By working with patients at an early stage we can substantially reduce study burden, improve recruitment and retention, and ensure that our trials truly address an unmet need for patients. Studies have already shown that drugs developed using patient-centric clinical trials are up to 19% more likely to launch and be more quickly adopted by payers.

Even in today’s world of big data and AI solutions, we cannot realistically understand all patients’ individual experiences, needs, attitudes and the likely drivers or barriers that will motivate them to adopt specific health behaviours. We can, however, understand a lot about the needs of a group of people living with a condition.
  
One tried and tested approach is to first seek a broad representative picture of patient challenges, experiences and unmet needs, typically through activities such as real-world studies, surveys and social listening. By doing this, we can build a picture based on real patient experiences (rather than our assumptions), before engaging with expert patient representatives in a more consultative and collaborative environment. Patient representatives can then speak on behalf of their community, to provide a sense of priority, or explore specific issues.

By considering both the mix and sequence of insights that we gather, we can piece together a clear and compelling picture that will help us to shape our clinical development activities, to bring maximum benefit for the patients we seek to help.

This is arguably the most important and the one that for many companies is the most difficult to wrestle with. When seeking patient perspectives or advice, how open are we to truly listening to what patients tell us? I am willing to guess that most of us have been in meetings where somebody has suggested a new way of doing something and the response was that ‘we have to do it like that because….’.

This mindset is problematic in patient engagement for two main reasons: it creates a barrier to potential clinical trial improvements and it jeopardises our relationships with the patients and experts with whom we say we wish to collaborate.

If patients tell us that a particular procedure is invasive and will be a barrier to study participation, let’s not allow ourselves to say ‘well, we have to do that’. It simply isn’t always the case. By looking at and even co-creating more innovative quality of life and patient-reported outcome measures, we can do better for patients in our studies and those who may later take our medicines. This is also why, as mentioned above, early integration of patient perspectives is so beneficial – it allows us to shape our services from the ground up, in a sustainable way in the real-world setting.

If we can be authentic in the way that we listen to and take on board patient advice. If we can cease defending our position because ‘we have to do it that way’, and crucially, if we can share our learnings effectively with the right people in our organisations, then we can make a more meaningful difference to the way we conduct the business of drug development, run our studies, engage with the public and, ultimately, patient experiences and health outcomes.

We’ve seen the conversation around patient engagement accelerate hugely over the past decade, from a place of uncertainty to a minimum expectation at so many levels. The next step, we hope, will see this become more systematic and authentic on the continual journey towards value-driven healthcare.

To find out more about Ashfield MedComms, visit https://ashfieldmedcomms.com

‘The real challenge is to truly embed patient perspectives in our programmes in a way that both influences operational strategy and supports patient outcomes’