5 innovative ways to improve patient engagement in clinical trials
White paper by Abish Ghimire and Bryan Rill, PhD
“Patient centricity”- the process of designing a service or solution around the patient-
is the new buzzword in health care services. The benefits of patient centricity in clinical trials have been acknowledged by the FDA as one of the most critical elements for any trial success. However, the majority of clinical trial protocols are designed with the “subject of interests” in a scientific experiment rather than with any input from the patients. In reality, patient centricity has never truly been adopted in clinical trials, which is one of the reasons for the 30 percent patient dropout rate.
What is Patient Engagement and why is it important?
The FDA defines patient engagement as “intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” The key words here are intentional and meaningful. Every small interaction must be designed with an intentional outcome, which allows an individual to interact and achieve the desired results. Although patient engagement has been acknowledged by the FDA as a key component for success of clinical trials, the industry still struggles to offer meaningful interactions with patients throughout the clinical trial journey. Other challenges such as patient recruitment, data management, and clinical operation processes take precedence over patient engagement, leaving patients’ needs unmet.
As much as digital interactions are important, proper bedside manner is equally important to create trusted relationships and a safe atmosphere for patients. Sponsors can benefit from taking a human-centered design approach, intentionally including engagement strategies throughout the patient trial journey. These interactions must be timely and meaningful so that they help patients achieve their milestones and feel appreciated for their efforts. A meaningful interaction often requires a clear understanding of participants' motivations, analysis of their behaviors, recognizing patterns, then forming an appropriate response. In the end, good engagement strategies will reduce the participants' burden and empower them with tools to complete the trial.
On one hand, patients are looking for passionate, empathetic, and humanized interactions with the site staff. On the other, they are looking for ways to stay organized and informed through digital interactions. We termed patients’ core needs as being “high-tech with high-touch,” an interaction that combines the connection of real-world engagements with digital interfaces and workflows that make managing the trial experience more fluid and seamless.
High-tech with high-touch is not just for patients. Currently, site staff are buried by the demands of inefficient workflows and multiple digital systems, creating less time for meaningful interactions. In many cases, the sponsors are far removed from the actual patient interactions, also blocking them from creating meaningful relationships. Patients deserve empathy, which means offering them proactive support, offering rewards, and celebrating their small victories and milestones. Site staff and sponsors deserve systems that enable better engagement by reducing burden and creating new opportunities for connection. A high-tech with high-touch strategy can deliver both.
Clinical Trials without Patient Engagement
In 2020, we took a deep dive to find out the reasons for high dropout rates in clinical trials. As a part of the research, we interviewed over 40 senior professionals in various roles in the industry. Our research found that poor patient experience exacerbates the problem, and that these poor experiences are closely related to a historical lack of patient-centricity and the enormous burden on research sites. These eventually result in delays and higher costs to sponsors.
Historically, the clinical trial industry has ignored or put little emphasis on patient engagement.
The FDA’s definition of engagement, for example, refers more to patient feedback informing trial design than actually engaging patients while in a trial. Patients are often labeled as “subjects, specimen, or guinea pigs.” These terms not only dehumanize the patient experience, but also prohibit studies from gaining traction, hence failing to recruit enough patients to even start a study. On average 50 percent of sites enroll one or no patients at all for their studies. Even when patients are recruited for trials, many feel disorganized, confused, lonely and often demotivated to complete the trial. It’s not surprising that 85 percent of clinical trials fail to retain enough patients.
Our research shows that trial providers want to give patients better experiences, but they are often plagued with inefficiencies and traditional ways of doing things. This site burden is magnified by an industry that has failed to adopt the innovations in cloud and digital platforms. Even with Clinical Research Organizations (CRO) that do adopt new systems, they often find themselves locked with a particular vendor without interoperability among various systems. When integrations and open Application Programming Interfaces (API) are offered, they tend to be inadequate in their function to complete user workflows. The effect of this is high turnover rates of Clinical Research Associates (CRA), who are fed up with the challenges of navigating multiple software systems that don't work well together.
Patient engagement is difficult to implement, as it’s more art than science. No two patients are alike, and what one patient may find engaging another may feel doesn’t satisfy their needs. The diversity across therapeutic area, demographics, digital access and fluency present serious challenges to developing an engagement platform that can be widely adopted. In addition, few trial protocols are designed with patient engagement in mind, hence there is no obvious monetary or tertiary benefit to the sites. This leaves sites with little incentive to provide an enhanced trial experience, leaving many enthusiastic participants disappointed and dissatisfied with the process.
Another issue is that even when engagement tools are readily available, most sites have very tight budgets and can’t afford to implement expensive patient engagement software. The organizations that do offer patient engagement solutions typically offer it as an add-on to their main product, lowering the significance and minimizing its impact. Many of these are built on outdated technologies, hence not leveraging advancements in technologies such as Artificial Intelligence (AI) and Big Data.
Overall, there is a dire need for a paradigm shift in how clinical trials operate. It is time to consider the use of software integrations (via open API), machine learning (ML), AI, and new communication technologies to improve clinical trial patient engagement. But lest we chase technology for technology’s sake, it is prudent to remember that high-tech must serve the high-touch needs of patients while simultaneously reducing site burden. Otherwise we will just end up with more software systems nobody wants to use.
Derived from our study, we would like to offer 5 innovative ways to improve patient engagement in clinical trials that can meet the needs of sponsors, sites, and patients.
A Novel Approach to the Patient Engagement Platform
A Patient Engagement platform is a patient-facing digital application that serves as a single source to view all of a sponsor’s clinical trials, allowing patients to perform self-service tasks such as education and support for participating in a trial. Although there is no shortage of companies that offer patient engagement “modules” in their product offerings, a careful analysis showed that the majority offer the same sets of features that focus heavily on technology rather than the human side. A novel approach is required for a clinical trial engagement platform, one that focuses on user experience (UX) while utilizing advancements in technologies to meet patients’ needs. Here we identify some key, differentiated, and innovative approaches to trial patient engagement, which allow alignment with digital and in-person experiences.
I: Health Literacy
A survey conducted by Continuum of US adults who searched for clinical trials online found that patients’ value both general education and specific trial information. Roughly 64 percent of patients wanted to learn about clinical trials in general, while 58 percent were searching for a trial, for a specific health condition. Today’s patients are more informed, digitally savvy and have a hunger to learn more about cutting edge research. The greater need is to create a trusted source of health information to participants. When lacking a reliable source, patients tend to turn to social media and often fall victim to unscientific, fake, and conflicting information.
Sponsors can not only provide curated content, but also source digital content from other reputable institutions such as the Mayo Clinic, NSA, John Hopkins, and other similar credible institutions. Content from a digital “library” can be delivered to patients based on profiles, behavioral analysis, preferences, and needs. Platform providers can also design algorithms that reward user behavior for content consumption, sharing, and participation in discussions. Increased health literacy means an informed participant that is motivated to complete the trial, while gaining invaluable insights on specific health conditions.
II. Patient concierge service
Clinical trial patients are typically older adults that are working and have family to take care of. Because of their busy lives, site visits and regular check-ins often become a hinderance on their daily routines. Sponsors ask and assume a lot from participants, who often struggle to meet the demands of their own lives while fitting in trial needs. Smaller tasks such as scheduling appointments, transportation, and possible loss of income from visit schedules are all factors that can create patient burden. Platform providers could supplement their digital services with patient concierge services, where they spend time to learn, understand patient needs, and work together to resolve them. This tactical approach not only earns patient loyalty, but also improves the chances of patient completing the trial.
III. Trial support community
The clinical trial patient journey can be a lonely one, sometimes without a clear destination. It is emotionally, mentally, and physically draining while they wait to see if and how a new drug or therapy improves their condition. Lacking a proper community of support from sponsors, they often turn to social media, blog posts, and unofficial forums to discuss their journey and share their story. These public social spaces are inherently risky for both patients and sponsors, who fear a trial being unblinded (where patients find out if they are on actual trial drugs or a placebo).
It is time that sponsors utilize technologies to remove barriers between themselves and patients. We can create a viable, live community of patients who feel part of something greater and provide them with a platform to motivate and support each other when needed. While the risk of unblinding a trial has been a significant barrier for adoption, advancements in AI technologies make it possible to moderate a community and mitigate this risk. The result could be a safe space for both sponsors and patients, a community to engage and learn from one another.
IV. Easy-to-use User interface
Many applications designed for patient engagement lack a human-centered design (HCD) approach, which has become a major win for successful health and fitness apps. Human-centered design begins with research efforts into patients’ needs, motivations, fears, and context. By designing with the end user experience as the central focus, a software platform can better meet its objectives. Impact studies have consistently shown that prioritizing user needs and facilitating ease of use leads to improvements in adoption, retention, and satisfaction with products and services. That is exactly what the clinical trial industry needs.
By contrast, a complicated and difficult to use engagement platform would never be adopted by patients or site staff. Clinical teams do not have the time or patience for complex new tools. For patients, many of whom are from older demographics, this approach becomes even more critical, as they are less likely to adopt new digital tools if it is difficult or unfamiliar to them. Ease of use is thus critical to the digital transformation we are seeing in the industry.
V. Empower with data
The primary benefit of a trial to patients is to know more about their health condition while seeking a positive intervention from a new drug or therapy. Yet in the trial industry, we fail to deliver health data and communicate benefits of the study. This is a serious gap, and is quite possibly a major contributor to recruitment challenges.
Many contemporary patients crave more health data and would like to control their data, and these numbers are growing as more and more people become digitally fluent. Providing tools to analyze and interpret research data as well as new information related to health conditions not only helps with transparency, but also keep patients motivated to complete a trial. Even though their health outcome may not improve significantly, having access to their health data empowers them to make decisions and manage their health. Given helpful information and the extra medical care that comes with clinical trials, even a patient with placebo will see how participation in the study benefits them. They may then be more willing to join the next trial, or even recommend someone they know.
Patient-centricity, a hot topic in healthcare, is slowly coming to the clinical trial industry. Improving retention will require keeping up with the experience expectations of trial participants. These patients are no longer willing “subjects” at the mercy of the clinical trial industry. They are active agents of their own wellbeing, and they have expectations of the trial experience that are currently not being well met. There is an opportunity for innovation that can benefit these patients, as well as site staff and sponsors of a trial.
In this white paper we have introduced patient engagement and why it is important, and what happens when engagement is poor. The industry is well aware of the financial and social impact of trial dropout, which is why many say that better recruitment is the #1 problem that needs to be solved. Here we offer that recruitment is not the biggest problem, but engagement is. If we as an industry can improve engagement from recruitment through trial completion, everybody wins. While engagement remains a difficult challenge, these 5 strategies combine “high tech with high-touch” to transform the industry and help solve its greatest problem.