Without a doubt, this has been a disruptive year in healthcare. But for those of us in the life sciences community, the global pandemic has only strengthened our resolve and commitment to ensure that drug discovery and development continue for patients in need. And so we have adjusted our approach, and worked with others in the industry to push innovations that keep trials on track, while keeping patients and site staff safe.
Recruitment and engagement are central to ensuring trial continuity; If patient interest or participation declines, the trickle effect touches everyone in the process, from researchers to marketers. This, then, has become a moment of reckoning for the pharmaceutical industry – it is time to look beyond the patchwork recruitment approaches of the past to not only address the immediate challenges posed by this global pandemic, but also facilitate the increasingly complex world of clinical development in the future. High patient safety standards, changing regulatory requirements and unforeseen obstacles like COVID-19 can make it difficult to ensure uninterrupted and effective drug development. Adding to that, ongoing challenges to participation at the site and patient levels make finding the right patients for the right trials in a timely and cost-efficient manner harder to achieve. For the first time we have the data, the technology and the depth of insight to rise to the challenge.
A new era of human-centric recruitment
For decades, patient recruitment has been a challenge for trial sponsors. Now, in a new era of recruiting that includes recruiting new patients beyond the traditional databases, research shows that 85% of patients are willing to participate in clinical research. However, today’s patients are far more healthcare savvy than in the past and want to be a valued partner in the research process, rather than passive research subjects. There is a new imperative to keep them informed and engaged before, during and after the trial in order to ensure participation. And clearly, we must be able to do that even when site visits are limited or shut down altogether. Together, these changes signal a growing need for a more human-centered approach to recruitment and engagement.
Along with the growing interest in trial participation, which has been an industry goal for decades, we are also seeing that a majority of patients who try to participate in trials (69%) are found ineligible and have to continue their search to find a trial appropriate for them. How can the industry better target patients for the right trials? By not considering adaptations in recruitment strategies, trial sponsors and the industry miss a huge opportunity to further clinical development while patient interest remains high.
Though COVID-19 has certainly nudged the industry to make changes, the truth is, the industry values patient insights and has been working for years to become more patient-friendly, long before the pandemic started. Trial sponsors engage patient advocacy groups to gather patient feedback on trial designs and incorporate outcomes important to patients into protocols while implementing patient-friendly technologies and data-collection tools in the process. However, to date these solutions are ad-hoc approaches, and while they are common among sponsors, they are only for an individual trial and are not scalable in the sponsor’s clinical development strategy for that therapeutic space and beyond. They have also fallen short in considering the full human experience of health, one that is increasingly empowered and enabled by technology. Instead, a holistic view and approach is how the industry can see the most significant impact on keeping trials up and running successfully.
Leveraging data insights
Sponsors certainly see the value of more agile and targeted recruitment strategies. Leveraging data, analytics and advanced machine learning and other tech-enabled solutions can help accelerate patient recruitment and overcome challenges of trial complexities that add time, cost and effort. In terms of gaining the most complete, the most relevant insights to identify the right patients for the right trials, real-world and clinical data sets from various sources, along with advanced analytics tools, are critical for enabling this kind of human-centric recruitment.
Gleaning data insights from various sources allows trial sponsors to take the guesswork out of the process and helps study teams better understand how to customize messaging to patients and address concerns they may have about participating or staying in trials. Additionally, these insights help sponsors adjust approaches and engage patients based on what qualitative data shows they need and behavioral data that looks into their actions.
Furthermore, collecting and keeping data insights in one central repository makes data useful to more than one site or study and allows sponsors to better identify and target patients for specific trials and related sites, efficiently accelerating the recruitment process. These data sets help teams identify and categorize patients based on demographic information, purchasing behavior, lab data, insurance data, genomics data, and other factors relevant to sponsors.
Once sponsors identify the patients, hyper-targeted campaign strategies are developed based on their communication preferences. Patients are more sophisticated about interpreting healthcare companies’ messages and tuning out content that feels irrelevant, time-consuming or misguided. But with data to back up their approach, sponsors can break through to raise awareness of trials via the appropriate touchpoints, whether by phone, email, postal mail, or digital engagement. This is fundamentally about connecting with patients as people, rather than as subjects.
COVID-19 has been disruptive, but it also provides a pivotal opportunity to accelerate innovation in patient engagement to deliver more efficient recruiting results, and a more human trial experience in general. A data-driven, human-centric approach ensures patients feel a part of the process and enables sites to meet their recruiting goals and ensure important drug development remains on track for those who need it.
IQVIA, formerly Quintiles and IMS Health, is an American multinational company serving the combined industries of health information technology and clinical research.