A clinical trial's path from initial study design to execution and completion is long, arduous, and often riddled with obstacles. Patients experience emotional, financial, and logistical burdens, negatively affecting patient recruitment and retention rates.
While site staff and researchers focus primarily on the medical and scientific facets of the clinical trial, patients and their caregivers are often expected to manage the logistics related to trial participation by themselves. This includes navigating the reimbursement process for travel and daily expenses, securing flights and hotel accommodations, and contending with more complex demands like passport and visa services or arranging temporary relocation. In many cases, these arrangements add to the weight of the patient's daily medical requirements and tending to the day-to-day affairs at home.
In addition to the scientific and commercial objectives of pharmaceutical research, clinical trials present a critical lifeline for patients around the world, especially for those with debilitating diseases with no known treatments or cures. However, recruitment and retention remain complex challenges for trial sponsors and contrac research organizations. More than 300,000 clinical trials worldwide are currently searching for 40 million patients,1 contributing to the rising costs of clinical research.
Fortunately, there are methods to combat these challenges. An increasing number of pharmaceutical companies and contract research organizations find that patient support services are a worthwhile investment. By alleviating the burdens caused by clinical trial logistics for patients, their caregivers, and site staff, patient support services can improve both trial recruitment and retention while increasing participant diversity.
Strengthening Recruitment and Retention
Patient coordinators are liaisons connecting sponsors, researchers, and patients. They are responsible for overseeing the logistical needs of individual participants, as well as anticipating and solving the unique challenges that occur with specific indications, such as Alzheimer's disease.
Trial sponsors studying dementia strongly prefer each patient to have the support of a caregiver. Many caregivers are elderly spouses or loved ones, limited by their own medical issues and requiring accommodations of their own. Elderly participants are also less likely to be comfortable using technology like email and text communication. Patient coordinators can increase the frequency of their personal outreach by telephone, which is not always the case for site staff.
Patients with Alzheimer's disease can be overwhelmed in busy environments like airports and train stations. Those participants usually prefer traveling by car, which at times means lengthy car rides to the nearest research site. Given the advanced age of the population and the physically taxing nature of car travel, these trips require detailed planning to account for frequent rest stops for stretching, meals, bathroom breaks, and in some cases, overnight stays.
Cognitive abilities in Alzheimer's patients often deteriorate rapidly, while clinical trial timelines typically span years in length. Patients may require additional assistance as their trial progresses and their mental health declines. Recently, a patient without a regular caregiver asked his coordinator to call him the day before and the day of each site visit to remind him of his appointment. His coordinator was happy to accommodate his request, and he was able to make his appointments on schedule.
This is only one example of the unique set of challenges that can accompany clinical trial participation. Historically, clinical studies have relied on a disproportionate number of middle-aged white males, due to limited healthcare access among other populations and the costs associated with trial participation.2 Today, patient diversity is top-of-mind for the pharmaceutical industry.
The Food and Drug Administration (FDA) and similar regulatory bodies continue to stress the ethical and scientific necessity of examining how potential drugs and therapies react across various demographic groups. Addressing barriers to participation during the protocol writing stage enables more people to benefit from trial research. It also increases the likelihood that trial outcomes will receive regulatory endorsement and achieve commercial viability.
Patients who know from the beginning that they will have direct access to a reliable partner throughout their clinical trial feel less encumbered by burdens of participation. They know they will have a logistical specialist at their side to help them navigate the travel portion of the trial, allowing them to focus on their treatment. As patient coordinators earn the trust of both patients and their caregivers, they build a relationship that enhances the patient experience and encourages long-term trial retention.
Global and Unforeseen Circumstances
On average, a clinical trial patient travels 40 miles from their home to participate in a study.3 However, in the case of trials for rare and ultra-rare diseases, travel is often far more extensive and compounded by the need for passports and visas, translation and interpretation services, and local medical care. For example, how do you best help a patient from South America traveling to a clinical trial site in the United States while cutting through bureaucratic red tape, overcoming language and cultural differences, and providing various forms of support for them in a strange country?
For starters, trial sponsors and coordinators should choose a patient support services partner with coordinators around the world. Local coordinators share a common language and time zone with their patients and better understand the many cultural nuances of their country. Coordinators also have the expertise necessary to navigate the regulations and challenges specific to their region.
Given the nature of rare diseases, temporary relocation is sometimes a more feasible solution than multiple trips between the trial site and participant's country of origin. More than 50% of rare diseases are among pediatric patients,4 so it is not uncommon for parents and siblings to relocate as well. In these instances, patient coordinators help secure affordable long-term housing, balancing the well-being and comfort of the entire family. Many go to great lengths to ensure a comfortable arrival for the family, often arranging the delivery of fresh groceries to help the family settle in. They also assist with repatriation at the conclusion of a trial or in the unfortunate cases when a patient passes away.
Local coordinators are also better equipped to address unforeseen circumstances. Take, for example, the frequently shifting government restrictions during the pandemic. Coordinators in the same geographic areas as their patients enabled rapid response to obstacles like mass flight cancellations. Having a global team with members around the world made it easier to facilitate cross-border travel despite differences among regions. In one instance, Clincierge coordinators in the United States and Latin America worked together to bring a single mother and her child from Argentina to New York. In addition to overseeing their more typical travel and logistical needs, they prearranged a safe place for the mother and baby to quarantine before treatment could begin.
An Investment in Trial Performance
When a study sponsor begins to create the budget for a clinical trial, it can be easy for them to question the necessity of patient support services. Between sponsors, researchers, and site staff, there appears to be plenty of support for participants. However, these professionals are tasked with the massive responsibility of managing the clinical trial itself, and their expertise lies in science, medicine, and administration – not logistics.
History has also shown that leaving these responsibilities to the participants is not ideal. Many patients struggle with emotional, financial, and technological hurdles that make them less inclined to enroll in a clinical trial. When coupled with the stressors of everyday life, the hesitancy of a patient to commit to a clinical trial is not unreasonable. Yet even the most successful recruiting campaign yielding a diverse and qualified patient population does not necessarily equate to a high patient retention rate for trial sponsors.
Losing a single patient during a clinical trial can mean giving up crucial data and extending trial timelines, often resulting in significant financial repercussions for trial sponsors and their research partners. These costs are exacerbated in studies involving rare diseases, where the pool of qualified participants is significantly smaller. Thus, investing in patient support services is a proactive measure that mitigates participation risk and strengthens trial performance.
- Havas Lynx Group. Homepage. Available at: https://www.patientcentricityontrial.com/.
- Oh SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, et al. Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. PLoS Med. 2015;12(12):e1001918.
- Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials. The Oncologist. 2018;23(10):1242-1249.
- Bavisetty S, Grody W, Yazdani S. Emergence of pediatric rare diseases. Rare Dis. 2013;1(1):e235579.
Scott Gray is co-founder and CEO of Clincierge, a provider of patient support services for clinical trials. Since 2013, Clincierge coordinators have managed logistics and reimbursements in more than 140 clinical trials around the world. For more information, visit www.clincierge.com.
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