Patient Centricity in Clinical Trials: Clinical trials are a vital step in the process of getting an intervention to the patients who need it. Putting those patients first, from the start of the design process to reporting the results, can help you succeed. Here we share insights from 25 years of clinical trials, to help you improve patient centricity.
Patient centricity has been gaining ground in healthcare for many years, but it is still a relatively new concept in clinical trials and the pharmaceutical industry.
Putting patients at the center of a clinical trial helps ensure that recruitment is sufficient and that participants stay involved for the duration of the trial. But deeper than that, it also contributes to the research itself being meaningful and aimed at the right outcomes. What’s more, patient centricity has financial benefits, protecting the trial against delays and increasing the chance of success.
While many biotechs and pharma companies are already experiencing the benefits of putting patients at the heart of their research, more have yet to get started.
In this article, we look at patient centricity in the context of clinical research. We tap into Siron Clinical’s 25 years of experience and share some recommendations for boosting patient centricity in your clinical trial, as well as the hurdles you may face in making it happen.
What is patient centricity in clinical trials?
Put simply, patient centricity is about putting patients first, including them in the trial process and ensuring they are considered in the decisions being made. A 2024 review of the adoption of patient centricity in the pharmaceutical industry, published in the International Journal of Consumer Studies, proposed a comprehensive definition:
“Patient-centricity in the pharmaceutical context is an approach aiming to put patients, their needs, and preferences at the heart of healthcare by educating them, involving them, integrating their perspective, and providing them with the best possible experience—to enhance health-related outcomes benefiting the patient, the pharmaceutical industry, and the society as a whole. Patient-centricity requires building trust with patients, a profound transformation of organizational structure, and partnerships with patient advocacy groups, healthcare providers, regulators, and payers.”
This touches on several of the factors we will explore in this article, including communication, timing, and partnerships.
What impact can a lack of patient centricity have on a clinical trial?
Imagine a biotech that has developed a drug to treat a rare disease. The research and development process has been successful, so they take the drug into clinical trials. This is where things go wrong: recruitment stalls, delaying the start of the trial – people don’t want to get involved. Budgets are squeezed, and progress looks uncertain. What’s going wrong, and how can they turn the trial around?
Patient centricity might be one of the factors to assess in a situation like this. If patients were not involved in the design and development of the clinical trial, it could be missing factors that are critical to the community. For example, patients may be physically less able to travel to a clinical site due to their rare disease, or they may have had a negative experience with a trial in the past, eroding their trust in the industry as a whole.
This happens all the time: clinical trials are designed and run without any involvement of the patients they are targeting until they start recruitment. If a trial is set up this way, there is a risk that it won’t meet patients’ needs, leading to failures in recruitment and retention, delays, financial losses and incomplete or insufficient data.
In short, not involving patients at the right time and in the right ways can be highly detrimental to a clinical trial.
Why the pharmaceutical industry is moving towards patient centricity
We have seen the shift towards patient centricity in practice over the last 25 years, driven by many factors, including patient empowerment and technology development. During their review of the adoption of patient-centricity, the team at the University of Liège in Belgium uncovered 33 factors leading to pharma companies adopting a patient-centric approach. These ‘antecedents’ are related to the industry, society, patients, and technology.
They note that the main reasons for companies to pursue patient-centric approaches are primarily economic, highlighting the potential financial benefits. The researchers also mention regulatory pressure, technology development and changes in patient behavior as contributing to the shift.
As we have seen over several years, patient empowerment is leading to change: patients are more eager to get involved in clinical research, not just by participating but also by providing input in the design phase. They also feel more in control of their own health and health-related data, which has implications for clinical research.
How to shift towards patient-centric clinical trials
Moving from a traditional approach in clinical research to a more patient-centric one requires change in several areas. Based on Siron Clinical’s experience over the last 25 years, here are some changes to consider that would move patients to a more central position in your trial.
Creating > co-creating:
Incorporate patients at every stage of the clinical trial process, ensuring their insights, preferences and opinions are considered throughout the research. For example, it could be beneficial to factor patients’ risk tolerance into setting thresholds. This might mean setting up patient sounding boards or engagement groups, ensuring that patients are part of the governance structure, and implementing a tailored communications plan.
Assuming > asking:
Even if something seems obvious, don’t just assume what patients need or want. For example, a survey of trial participants revealed that many are not in favor of home visits, despite these being common among decentralized trials. Asking for input and feedback on trial design, outcome measures, and monitoring approaches can help improve retention, resulting in more complete data.
Rigid > flexible:
Incorporating new activities that facilitate patient centricity requires the sponsor to be flexible, in terms of both what they do and how they do it. For small companies especially, setting up programs of patient engagement and education, for example, could stretch human resources. To support the increasing adoption of patient-centric approaches, it’s possible to work with specialist companies like Admedicum. And when engaging a CRO like Siron Clinical, a Functional Service Provider (FSP) contract can provide the flexibility you need to adjust to patient centricity.
Siloed > collaborative:
Through partnerships with patient groups and healthcare facilities, you can create fruitful connections with the patients you’re aiming to help with your clinical trial. Research has revealed cooperation between stakeholders to be essential when it comes to ensuring patients benefit from clinical research. While all clinical trials benefit from collaboration, for some it is even more important. For example, the target group for recruitment to rare disease clinical trials is by definition small, and engaging with patient groups is therefore vital to fulfil enrolment requirements.
Broadcasting > engagement:
Communication is a key factor in patient centricity. Today’s empowered patients are motivated to manage their health, and many want to play an active role in the development of their healthcare, including through clinical trials. Traditional approaches to communication, such as sending information packages at the point of recruitment, could be improved to increase engagement and involvement. Think about focus groups, online meetings, regular surveys and alternative formats. Most importantly, tailor what you do to the target group.
Digitally enabled > digitally empowered:
Digital technology and approaches like decentralization can boost patient centricity, as long as the decisions you make about what digital solutions you use for communication, monitoring and data collection are made with patients in mind. From email to social media, AI to wearables, it may be tempting to choose the latest digital tools, but will your participants respond positively, or would they prefer something different? In a previous article, we shared some questions to ask when making decisions around digital tools.
Making a wider impact through patient centricity
Patient centricity is an increasingly important aspect to consider when you’re designing and running a clinical trial. It’s also part of a wider movement in healthcare that is aimed towards putting the patient at the center of their own healthcare.
As digital technologies like AI tools continue to evolve, patients will become more empowered and health literate, in turn potentially increasing their motivation to get involved in clinical research.
By building patient centricity into your trial, and by collaborating with healthcare facilities, regulators, patient groups and other stakeholders, you can contribute to this wider goal, helping shape the future of healthcare.
At Siron Clinical, we have been putting patients first for 25 years. If you want to make your trial more patient-centric but you’re not sure where to start, contact us. Our expert CRAs are ready to support your trial.
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