Patient enrollment represents a central part of a clinical trial. Simply put, if patients aren't enrolling, the study isn't happening.
The success of enrollment, especially in an on-budget and on-time manner, is dependent on how willing the patients are to enroll and how well the sites are motivated to involve the patients in one trial versus another. With much focus put on patient-centricity these days, it stands to reason that sponsors and CROs alike would invest a lot of time into thinking like a patient when designing and planning clinical trials.
One challenge that faces patient enrollment, often seen in difficult to recruit indications or indications among sick populations, is transportation and travel. In some countries, a train ride is all that's needed to get from points A to B. In others, it's nowhere near as easy. This is particularly true for patients that are chronically or terminally ill, or those with significant financial challenges. It's reported that transportation concerns are a significant barrier to entry for patients enrolling in clinical trials.
But what does the current travel landscape look like? And what advances, in this time of incredible technological growth, look like? Recent statistics show that only about half of clinical trial sites offer transportation reimbursement in one form or another, but taxi services are still overwhelmingly the most common form of transport.
Thinking Like a Patient Should be Uncomfortable
Committing to be patient-centric means more than examining a demographic readout or inviting a patient advocacy organization to contribute to protocols. It requires us to consider the true ramifications of disease on a patient's life. It means looking them in the eye and imagining the cataclysmic shift of a cancer or an autoimmune disease diagnosis and understanding all the intersections of their lives that change. The harsh reality is that many studies require taking time out of sick patient's lives, patients who may know their prognosis is bleak. Late stage cancer patients consenting to clinical trials are giving something irreplaceable to the study: their limited time. And successfully enrolling patients hinges on a deep understanding of that limited resource.
And for travel, the focus should be on making the process as comfortable as possible. That doesn't mean just enlisting any travel vendor. It means stopping to think about what travel would be like for a patient with a terminal diagnosis. Or, it means considering what a lengthy trip might mean to a patient with Crohn's disease; or the comfort of a seat for a patient with severe rheumatoid arthritis. Patient centricity means stopping and truly considering the ramifications of a patient's disease, and how that impacts their participation in clinical trials even before they've ever set foot in a clinic or hospital.
Most frequently, sponsors or CROs contract with travel vendors to help arrange patient transportation. This is, of course, essential from a privacy perspective. However, just because the vendor is the one working directly with the patients doesn't mean CROs are off the hook for quality. There's been a lot of discussion regarding ride-sharing or Uber-like options, one of the only signs that clinical trials transportation is changing at all. Although it's a promising idea on the whole, this approach works best with patients who are relatively healthy. Because it's not just about physical comfort, but about the psychological comfort of patients as well. It's likely that sponsors and CROs are attracted to ride-sharing concepts because it promises cost-savings. Sure, saving money is a good idea, but whether or not the model will work on a large scale is up for debate. And considering Uber's reputation for spotty and inconsistent service quality, it would beg the question if such an approach even makes sense for patient populations at all.
We need to be vigilant with transportation vendors and wary of quick fixes. This should include a robust vendor management audit, on-site visits, review of referrals, and discussions about the variety of services offered. Ultimately, the sponsor or CRO should be the entity making the call about the level of service delivered during transportation, not waiting for vendors to rise to the occasion.
If possible, CROs could even work directly with transportation vendors to design new, innovative approaches to travel: consider the comfort of the car seat, the availability of toilets, the temperature and amenities included. What worked for one clinical trial in a certain indication may not be as effective in another.
Digging Deeper in the Commitment to Patient Centricity
The heart of patient centricity isn't a blanket statement promising to focus on patients as a whole. It's action. It's a radical shift from thinking of patients as data points – part of a product – to understanding them individually. It's about learning to see each patient—their disease, their age, their lives, their time.
Mitigating the burden of clinical trial participation is absolutely essential to enroll studies on time and to provide patients with a positive experience. Making that first impression, going the little extra mile by offering better transportation options, will go a long way in ensuring that everything possible has been done to get life-saving drugs to market in a timely, cost-effective way.