The Patient at the Centre of new Technologies in Study Design

February 26, 2019 Becky Hurt

By Tom Ruane, Global Head of Patient Recruitment, PAREXEL

One of our primary areas of focus at PAREXEL is trying to take the best of innovation to help engage and recruit patients at the site level. At the same time, keeping the burden of this task down for the Site Staff.  The products out there today encompass all the latest technology trends: artificial intelligence, Big Data, genomics, analytics – we are even exploring applications of blockchain. These technologies all look exciting, with tremendous potential to improve the patient experience.

Patient recruitment is a rapidly evolving and fluid space; our team is currently tracking nearly 400 companies that offer some kind of patient-recruitment service, many of them digital, and a lot of them quite innovative. The issue is identifying the diamonds in the rough. As a technology CRO, we rely on agile, nimble partners to provide the right tools. As the technologies are continually being finessed, there is a new willingness of the patients to be involved in using these new tools, along with their families and medical professionals at the sites.

Evaluating the Impact and the Value

But when you write down the cost impact on your study and submit the budget to the finance team, it’s a very different story. And aside from the cost, what is the value for the patient? In terms of the study design, what does it mean to the study teams? We know from speaking to our pharma partners that up to 60% of endpoints inserted in a protocol are not actually used. Are all these endpoints necessary? If all these endpoints are included, will it dampen the patients’ willingness to take part? Moreover, there is an obvious cost savings in reducing, not expanding, the endpoints. Just within the past year, we’ve seen that protocol amendments are beginning to delay the process and add costs. These are some of the factors we are contending with as we grapple with today’s realities: the number of studies that are delayed, the increasing complexity of the protocols, and the distance of the patient from the clinical-trial site.

For us at PAREXEL, the key focus is on the patient journey. We look at it particularly for the study-planning stage, with the patient at the center of that planning. There is simply no question about the value of some of these innovations in our drive toward patient-centricity. For instance, you probably remember the focus groups that used one-way mirrors and video to try to find out what it was like to live with a disease, and what might encourage patients to engage in the study. Now, with the explosion of social media, we can carry out the same exercise, but do it remotely. We can listen to patients in real time, in any part of the world, in any disease area. We can use those insights to craft the elements that might engage these patients in the research, and to see what burdens they might perceive that depress participation.

Engaging Patients Through Insights and Burden Analysis

Our patient-recruitment team is using social media chatter and analytics for what we call patient insights and burden analysis. In addition, we involve the nurses and physicians at our Alliance Sites to gain their perspective beyond what the patients are observing. With much current discussion around Virtual and Siteless studies, our view is the physicians and nurses will always be key stakeholders in this. At least for the foreseeable future, the doctors and nurses will still be the “air-traffic controllers” of patient care.

Here are a few practical examples of how these insights are helping us design the protocols in a way that encourages patients and their families to take part. And let’s note that the family dynamic can be surprisingly important.

  • In a recent pediatric-oncology study, we found that one critical element was involvement of the siblings – what the study team called a “study buddy.” Including the siblings in the site visits and procedures resulted in a far higher degree of engagement, and patients were dropping out less frequently.

  • We worked with a sponsor in determining various merits of using flexible sigmoidoscopy versus colonoscopy for irritable bowel disease. Through social listening, we found out that the patients considered the biggest issue not the size of the scope – the physicians’ assumption – but bowel prep.

  • One of our technology partners, AiCure, enables the use of smartphones to monitor compliance. The tool not only checks whether the patients are taking their medications; it also gauges a patient’s self-administration techniques, for self-injections or even the correct use of an asthma inhaler. We’re seeing a lot of positive engagement there.

Facing Realities – and Resistance

Then in the brain-health field, companies like CANTAB Cognitive Research and Cogniciti are helping patients gauge their own propensity to develop dementia at some future point. But we made a surprising discovery when facing some difficulty recruiting the patients. In fact, the most effective method turned out to be decidedly low-tech: sending coordinators from the site to nursing homes to test these brain-health tools in person. And this approach was far more economical than using digital channels. It’s hard to quantify the ROI of these different tactics.

When we run our feasibility analyses, we survey the sites on a given protocol, inserting the question: Do you think it would be helpful if any of these study elements were done remotely at the patient’s home? The physician might say, “Yes, it would be great if the patient doesn’t have to hike back here for a blood sample!” On the other hand, there are issues around e-consent, where the physicians prefer to be hands-on. For example, the technology exists for patients to use touch screens to gauge their level of comprehension about the treatment, but the doctors consider that their job.

My conclusion is that we are now poised at the inflection point between technology disruption and the reality on the ground – the patient experience, the family, the site staff, and of course, the cost. We need to ask: Is this new idea the latest sparkly solution looking for a problem? Is this innovation being adopted to satisfy the needs of the back office, or will it truly help patients and their families?

There must be a balance. What’s critical is mitigating the risk. Many of these innovations will help engage patients by delivering a more positive experience. They will help reduce cycle times. But it’s a very complex area that involves the whole continuum of those participating in the trial. You can’t just bolt these tools onto a study and sit back to see what happens.

That is the contemporary discussion taking place at PAREXEL. We have coined a new term to describe the sensibility required: operational empathy. It’s the art of understanding the potential benefits of something new and exciting, weighing its full impact on a given study to judge its operational feasibility.



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