2025: The year of the patient?

Across the clinical trials industry last year, there was much greater appetite for listening to patient insights and considering the patient perspective. Companies are starting to understand the value of doing this and of working with patients to inform clinical development.

As an industry, we are waking up to the need to change the way we approach patient insights to improve our drug development processes.

Diversity remains at the fore

While diversity remains a focus of the industry, we must be careful to avoid complacency and the perception that we have “solved” the issue of diversity and representation in clinical trials. Diversity is not a discussion that will ever go away – nor should it. We need to continue to ensure that we are bringing historically underrepresented communities into clinical trials and building better bridges with them in order to facilitate this.

As an industry, we also need to get better at identifying different forms of diversity, and how they affect factors such as health literacy, clinical trial literacy, and access to technology. For example, low health literacy is disproportionately common among low-income and minority groups. Therefore, it is important for clinical trial providers to focus on prioritising clear communication and education to ensure that potential trial participants understand the importance of clinical research and the role they could play in helping to develop potential new treatments, as well as allaying any concerns that they may have.

More efficient recruitment required

Sponsors are still struggling to recruit the right population samples for their trials, and their approach to patient recruitment remains transactional. We can and should be moving faster to change our approach, especially as time is life for many of the patients we serve. Being as efficient as possible with recruitment could be life-saving, and some organisations are beginning to recognise that focusing on this will really help them to get their drugs to market faster. However, there needs to be broader recognition that recruitment is an industry-wide issue; not one that solely affects specific trials or therapeutic areas.

To address this issue, the industry needs to be more consistent on its use of pre-trial registries. Some companies are already starting to build these research-ready pools of patients, but these numbers are not high enough. Until we start to look at patient recruitment more holistically, it will continue to be a drag on resources, a drag on budgets, and on the clinical trial journey more broadly. The industry needs to stop seeing clinical trials as a one-off situation, and instead understand that trials are part of a more dynamic process, where one trial is just part of the equation.

We also need to focus on building energy and enthusiasm for clinical research in patient communities in a new way. There is a growing understanding and appreciation of clinical research as a care option – not a final option – which will be critical in helping organisations to find patients and give them another potential treatment.

Bringing patients along the journey

A key part of this is involving patients in the clinical trials process as early as possible. For example, at Medidata, our ‘patient centricity by design’ methodology ensures that patients’ perspectives are at the forefront of any decision made regarding the integration of digital tools or solutions in a clinical trial. With any trial, the focus must be on implementing solutions that improve the patient experience and reduce the burden of participating in clinical research.

It is really gratifying to see companies beginning to view themselves as being patient centric – it shows that the industry’s approach is maturing as these terms are becoming part of the lexicon. A notable development in recent years has been sponsors’ willingness to engage with patient advocacy groups more frequently in order to directly engage with patients and understand their needs and concerns.

As a result of this, the industry is set up for success in 2025 and ready to continue to make progress. We are likely to see patients being involved earlier in clinical trial design, in areas such as protocol design and review. We may even get to the point where we can build research collaboratives for patients, where we can assess whether trial outcomes that are being assessed are actually beneficial for patients in the way that pharmaceutical companies believe them to be. This could also help identify the pressing needs of patient communities before companies start developing a molecule, to ensure that it is addressing symptoms that are relevant to the patient population.

Empathy breeds success

Overall, 2025 is set to be an impactful year for furthering the role of patient insights and perspectives, which in turn should help to address some of the challenges the industry faces with clinical trial recruitment. Companies that truly embrace the concept of patient centricity – and start to view clinical research through an empathetic lens – will be well-placed for success.