Patient recruitment and retention is crucial to the success of clinical studies, but this can also be hugely challenging. Even before the pharma R&D backlog resulting from the COVID-19 pandemic, most clinical trials did not meet their recruitment deadlines. This can have dire consequences, with patient access to potentially life-changing treatments either delayed or ended before it has even begun. It also has profound financial implications for trial sponsors.
COVID-19 has exacerbated this situation, with sites struggling to cope with the still-overloaded R&D pipeline. While most of the focus is, rightly, on patient enrolment, we cannot forget the crucial element of patient retention in securing the viability of a clinical trial. It is therefore vital that sites are supported to ensure patients remain engaged for the duration of the study.
The need for patient retention support
The rise of digital technology within clinical trials is a two-sided coin. On one hand, it is making it easier to build studies around patients’ needs, circumstances and locations, and reach large and small patient populations for enrolment purposes.
However, we know this technology does not automatically translate into a better patient experience. Not all patients are digitally savvy or have access to digital technology and, while digital-based recruitment methods can result in more patient referrals, this subsequently increases the pre-screening burden on sites.
Clinical trial sites are often not well equipped to deal with these challenges due to other time and resource pressures. A new initiative that Innovative Trials is trialling in the US aims to bridge the gap between busy site staff and patients so that everyone involved gets the support they need.
A patient-focused support service
Our Patient Navigator service utilises experts in clinical research to ease the burden on sites by assisting with patient recruitment referrals and improving patient retention.
We currently employ three individual Patient Navigators in the US with more than 13 years’ experience between them. Each has an excellent understanding of local culture, is bilingual in English and Spanish and a trained mental health first-aider. Together, this means they are knowledgeable about the clinical trial process and local healthcare landscape, understand the journey a patient will typically experience during a trial and are readily available when patients and research staff need them.
Putting patients’ needs front and centre
Our Patient Navigator service is developed with trial participants and their caregivers at its core. Its primary goal is to ensure patients and their families receive any support they might need from the beginning of their clinical trial journey.
During the enrolment stage, our Patient Navigators can manage the pre-screening process for digital referrals, engaging quickly with potential patients and overseeing all activity until the screening visit is completed. This ensures those who are eligible are quickly identified so that sites receive higher quality and engaged referrals. It also frees up research staff to focus on other aspects of study delivery and patient care so that the needs of those participating are being met in other areas and the trial can progress in a timely manner.
Throughout the study itself, our Patient Navigators provide personalised support to patients and their caregivers. Available in a similar way to a helpline, they can assist with any questions that patients or their caregivers may have related to their clinical trial. Anticipated questions could be about the treatment under investigation, technology or devices that patients are required to use as part of the research, or the clinical trial process in general. Assistance can also be provided with the long-term follow-up of patients through regular check-ins, which is particularly helpful for studies that run for several years.
Having a support system such as this in place, where patients can speak to a consistent contact any time they need to, for the duration of a clinical trial, fosters good communication and trust, and results in increased engagement during the study.
With the rise of personalised medicines, there is increasingly no ‘one-size-fits-all’ design for clinical trials. This can make patient recruitment and retention challenging, particularly as we continue to tackle the research backlog caused by COVID-19. Our Patient Navigator support service, which we are looking to expand beyond the US in the coming months, is bridging the gap between site staff and patients to ensure participants feel heard and engaged and sites feel supported. Ultimately, this will help accelerate the recruitment of patients for clinical trials and improve patient retention to avoid early trial termination.
