Patient-centricity is a critical component of a successful clinical trial, which can improve patient enrollment and retention. It helps overcome the many challenges faced by study teams by addressing the growing demands of an evolving patient population – who are actively engaged in their healthcare.
So, what do patient-centric clinical trials look like and what are the key benefits?
Patient-centric clinical trials are driven by a sensitivity to patient needs, provide incentives for consistent participation, offering solutions that ensure engagement and have patient support mechanisms in place. The important principles of a patient-centric approach includes:
1) Aiming for quality and precise patient identification
Clinical trial success begins and ends with the right patients. Here, it is crucial for you to define with precision the target patient profile before recruitment commences:
- What is the patient demographic?
- What is the incentive for participation?
- How does the disease impact the patient’s life?
- How well does the patient understand their disease?
- Are there current, approved treatments available?
A patient-centric approach means ensuring you are at the right place and time, ready to profile, identify and engage potential recruits. This helps to promote quality patient selection and thus generate quality trial data.
2) Fully understanding patient needs
With a patient-centric approach, you can ensure that the trial objectives are aligned with the holistic needs of the patient. Truly patient-centered participant profiles go beyond how a patient’s medical condition might be affected by study participation to consider how the study might impact the patient holistically:
- Will it impact work or school?
- Will it impact relationships?
- Will it interfere with a patient’s personal life?
- What are the patient’s unmet medical needs?
- How would trial participation impact family/caregivers?
- Will patient’s treating physician be supportive of trial participation?
To ensure answers to these questions are accurate and can be effectively addressed, companies can gear themselves towards identifying the specific needs of patients as well as anticipating how patient needs might change throughout the study. The most effective way to gain this understanding of patient needs is to include patients from the outset, eliciting their input and perspectives into study designs and considering their fears and expectations. Communicating with patients via focus groups, surveys, and mid-way reviews can help determine patients’ needs pre-trial and during the trial, reducing levels of burden.
What are the specific benefits of patient-centricity in clinical studies?
With the principles of patient-centricity in place, companies can expect to reap specific benefits in terms of patient recruitment and retention:
Increased awareness and engagement
Depending on whether they are in Europe or the US, only 1-2% of patients know clinical trials are an option for them.1 Ensuring that patients are made aware of the opportunity to participate in a study is one of the benefits of adopting a patient-centric approach. Companies with a strong patient focus increase the visibility of their clinical trials to ensure they reach patients with the right profile. This can be achieved by accessing patient databases and online patient portals to reach potential recruits across the globe. Social media is also a powerful platform for targeted advertising campaigns that engage the right patient profiles.
Reduced dropout rates
Many patients struggle to stay in a study due to the inconvenience of trial protocols and the impact it has on their daily lives. There is a clear need to improve retention with more hands-on patient support and consistent engagement touchpoints with patients, as facilitated by patient-centered strategies. For example, patient education, patient and caregiver support, and appointment reminder tools are all patient-centric strategies that can motivate patients to see a study through to the end.
Improved patient experience
Patients often struggle with complex protocol schedules, procedures, and consent forms, which can deter them from joining a study or lead them to abandon it part way through. It’s important to improve the patient experience by reducing the burden on patients as well as their caregivers and families. With patient-centricity, researchers prioritize the experience of patient and carers by ensuring there is simplicity and clarity in the procedures that patients undertake. With an improved patient experience, patients will be more likely to fully report on their outcomes, which is integral to gaining quality clinical results.
A cost-effective solution to recruitment
Many companies struggle to achieve sufficient recruitment on time, which can carry a hefty price. The solution isn’t far away, however. Patient-centric strategies can arm companies with a vast array of creative opportunities to reinvent patient recruitment to ensure study goals are achieved.
To learn how partnering with a third-party provider can help you incorporate patient-centricity into your study for recruitment success, download our latest white paper here:
- Burrows, A. (2018). ‘Tackling the patient recruitment challenge – Willie Muehlhausen, ICON’. Knect365. Retrieved from: https://knect365.com/clinical-trials-innovation/article/c30f7d4a-d1d3-475a-aa97-2bbef2cf23c8/patient-recruitment-challenge-willie-muehlhausen-iconl [Accessed 12 October 2018].