The implications surrounding Verily’s newly announced strategic alliances with pharma to find new ways to reach patients along their journey are significant to the world of clinical trials. By developing tools that make it easier for patients to enroll and participate in trials, the industry has a real opportunity to lean into patient needs by possibly helping to reduce the stress—taking a big step toward thinking more “humanly” about clinical trial recruitment.
Through our years in the industry and personal experience with clinical trials, we feel the timing couldn’t be better to take a fresh look at how we, as pharma marketers, approach recruitment and retention of patients in clinical trials. Given the ultimate goal of a trial is to bring safe and effective treatments to market for the right patients, it’s not surprising that the focus is (and should continue to be) how to maximize success for results that prove safety and efficacy.
However, when it comes to patient recruitment and retention, we believe it’s time for the industry to think beyond targeting tools and numbers. It should be about building an engaging, empathetic, and effective clinical trial experience—one that meets the needs of the patient and the trial in a way that maximizes both chances of trial success and enables a positive patient experience.
This feature article will highlight evolving human considerations, needs, and market dynamics that demand the industry looks at clinical trials more holistically and less logistically. We will provide recommendations for approach as well as a real-world trial experience from one of us. Let’s begin there.
I have worked in the industry and for the past 10 years I’ve been fortunate to be involved in reimagining clinical trials from recruitment through to designing unique experiences for some of the biggest pharmaceutical companies in the country. Six weeks ago, however, I started on a new clinical trial…but this time, I was a patient.
Twenty years ago, I was diagnosed with Inflammatory Bowel Disease (IBD). It’s been a heck of a journey. There have been many treatment successes and failures along my journey that contribute heavily to these daily ups and downs. While there have been many great medical advancements in IBD over the course of two decades, there isn’t a cure and, for the most part, doctors are relegated to cycling through the different advanced therapies because more often than not they unfortunately fail.
It’s a tale of failed treatments, being frustrated and looking for answers, and taking my chances in a clinical trial. It’s also the first time my personal and professional clinical trial worlds have collided and given me reason to pause and reflect.
Where to Start
A great starting place when initiating work on a clinical trial is getting a holistic understanding of the trial landscape. To do this, we in pharma typically orchestrate interviews with customers, set up co-creation labs to garner insights, apply design learning principles to craft solutions and validate.
What we learn from months of immersion spanning numerous trials is that clinical trials are indeed clinical. From the first recruitment touchpoint, to screening, baseline visit, and beyond, each significant (and insignificant) milestone is designed with one thing in mind—data. Although “data” is in fact the ultimate endpoint of a clinical trial, it doesn’t necessarily have to be the ultimate goal of the recruitment process and experience.
Regardless of the trial, each seeks to improve similar aspects: Pain points, opportunities, needs, requirements, pressures, and expectations, and all for a great cause—bringing essential therapies to market—thus the need for data. Despite their heroic efforts (and heroic they are, due to the unbelievably high failure rate, regulations, and cost of clinical trials), each aspect of the trials—from design through to the implementation—initially lacked consideration of the most important thing: Their patients.
Pharmaceutical companies have an opportunity to improve how they design, recruit, and support patients throughout a clinical trial. They need to make clinical trials more human. They need to place their patients at the center of their solutioning. With so many other key areas of a trial to consider, this may seem unnecessary or unproductive. After all, companies aren’t required to submit patient satisfaction surveys to the FDA, so why start with the patient, and not the molecule?
The answer is simple. Taking a patient-centric approach can improve the design and execution of almost every step of a trial—from recruitment to post-marketing observational study. Let’s explore some key aspects of clinical trials and how they can deliver impact.
Most pharma companies will tell you that it’s all about speed and efficiency, and they’re not wrong. Trials are designed to take from patients. They take data in the form of bloodwork, scans, procedures, scopes, tests, journals, questionnaires, and samples to name a few. This is extremely taxing on patients. However, it might be time for us to stop thinking of the patients we recruit as N=1 and think about where they are physically, geographically, and emotionally in their journey.
This approach requires much of the same “data” gathering, but applied from a different lens. We need to start looking at the questions we are asking when we recruit (who, what, and where) and start asking why these elements are important to the trial and how they might impact our recruitment.
Much time and effort goes into finding participants for a study, but far too often the design of trial locations isn’t grounded in high concentrations of potential participants, an appreciation of how far these participants will have to travel, and/or what competition (other clinical trials with similar/the same inclusion and exclusion criteria) exists. If these, and other market dynamics, are considered earlier in the process, we can heavily influence the cost and time associated with finding quality participants and employ newer methods of recruitment that reach the patient when life circumstances prevent them from physically traveling to a trial center themselves. Here, we can imagine the possible positive impact Verily’s novel solutions could have on the patient’s clinical trial experience:
As I sit there in the hallway waiting to see my specialist, someone approaches me, introduces herself, describes the study in two or three sentences, asks me if I am interested in participating in a clinical trial and swiftly hands me a stack of papers. It’s clear she needs patients and I probably look like a perfect candidate…can she get the data?
In addition to geographic considerations, patient support materials can improve.
Each touchpoint in the recruitment phase can be crafted with patients in mind. The tone, tools, and timing of recruitment can have a big impact on someone’s willingness to participate, regardless of if it’s because they are desperate or altruistic. We can anticipate all the types of questions that patients and loved ones might ask and address them with easily accessible FAQs. Introducing visual elements can help more clearly convey critical moments in the journey, including how long it will be and what the expectations are. Let’s get the information out of a chart and into a journey that resembles what a “day in the life” of a trial might look like.
Similar to making patient support materials better and more empathetic, patient communication during the trial can make a world of difference. Speaking to a patient as a person involved in a brave event, rather than as a number (i.e., N=1) not only can help ease their nervousness or anxiety but help give them a sense of empowerment—that they are helping to fight the disease they are battling. Every interaction between doctor and study coordinator is an opportunity to address concerns, answer questions, set expectations, and simply let the patient know they aren’t in it alone. After all, the patient is going through the experience for the first time, not the 50th like the study coordinators. People who are in a trial are often emotionally overwhelmed due to the gravity of their situation and a little bit of information can help go a long way.
Typically done the same old way…stacks on stacks of paper just suck! This is where technology, user experience, and design can heavily impact the experience and outcome. Imagine suffering from debilitating rheumatoid arthritis and being asked to fill out a weekly 20-page questionnaire when you can’t even grasp a pencil? Solving how we collect critical data throughout a trial can lead to completion rate, quality of response, and even help retention by removing cumbersome and often onerous elements of documentation.
At the end of the day, the results of the clinical trial determine if the drug gets approved. But how we communicate results can also be more patient-centric—keeping participants in the loop every step of the way. Results shouldn’t be something they have to go out and seek. They should be delivered to participants directly and immediately, as appropriate.
By making the trial recruitment and journey more human, it might also impact trial success. By following the above steps and focusing on WHERE the patients are, HOW they are impacted along the entire journey, as well as WHY clinical trials of similar drugs failed, the industry will be better poised to battle these terrible diseases with hopefully greater success. It’s time we designed trials with our patients in mind. It’s time we thought about the end-to-end experience of trials. It’s time we give back to our patients.