Clinical Researcher—November 2021 (Volume 35, Issue 8)
RECRUITMENT & RETENTION
Scott Gray
Although the United States contributes more than two-thirds of global trial participants, according to recent statistics published by ClinicalTrials.gov, only 32% of registered trials occur solely within U.S. borders.{1}
Cross-border travel creates significant complexity for trial sponsors and clinical research organizations (CROs), who must contend with complicated travel logistics, participant and family unease, international regulatory compliance, and more. Although many of these challenges have been brought to light in recent years, COVID-19-era travel restrictions have only exacerbated these issues.
Meanwhile, challenges with participant retention delay 80% of clinical trials by at least one month, with potential losses of $600,000 to as much as $8 million per day.{2}
Most CROs who partner with pharmaceutical companies do not have the network or resources necessary to manage highly sophisticated and diverse logistics requirements. Organizations that understand these limitations can engage companies focused on patient support services, providing personalized and comprehensive logistical support to help patients reach distant trial sites.
Patient support services are an investment in trial performance. They help reduce the burden placed on patients, caregivers, and site coordinators while improving trial retention rates and accelerating the commercialization of new treatments.
Navigating Border and Travel Issues
Navigating international travel, particularly for extended periods, requires logistics expertise, a global network, and ample time and persistence. In addition to travel coordination, documentation (passports, visas, pandemic-era forms, etc.) and health requirements (immunizations, timed COVID-19 testing, etc.) must be accounted for and arranged.
Engaging support services to navigate these issues is even more critical for clinical trials in the rare and ultra-rare disease space. For these studies, sponsors must cast a much wider geographic net and increasingly compete for the attention of a limited number of eligible participants to satisfy recruitment and maintain retention.
Rare and ultra-rare disease trial participants often have complex needs when traveling. They may require medical equipment or medical services between their origin and destination, and site visits often involve the patient and a caregiver, as well as family members. With both governments and private industry increasingly incentivizing and launching trials for rare and ultra-rare diseases,{3} the need for patient support services continues to grow.
It takes a team of patient coordinators around the globe to help manage these unique challenges. Recently, a coordinator helped a patient navigate the logistical challenges associated with traveling to Russia, a country with relatively few domestic airports or rail stations compared to other regions of a similar size. The coordinator’s local understanding of ground transportation options and travel routes was essential in getting the patient to the trial site quickly and safely.
In another case, a Venezuelan couple had to prove their need for access to urgent medical treatment. Patient coordinators helped them obtain special humanitarian permissions to relocate across borders to participate in a long-term trial. After several years living abroad, a coordinator helped repatriate them back home.
Reducing Financial and Emotional Burdens
Dealing with a chronic or serious health issue while preparing to participate in a clinical trial is extremely stressful for patients and their caregivers. The financial burden can be intense, particularly for families traveling to countries with higher costs of living. Patient coordinators manage prepayments and expedite reimbursements and stipends on behalf of trial sponsors and CROs, making it easier for patients to commit, participate, and remain in their clinical trials.
When traveling for extended periods, it is not unusual for families to contend with sudden changes in currency value, resulting in unexpected cost increases and unplanned expenses. In Argentina, for example, inflation can cause travel and lodging costs to double in only a matter of months. A patient support coordinator can help sponsors, CROs, and families anticipate and manage these challenges in real-time. A coordinator currently working with patients in Brazil is in regular contact with Banco de Brasil and Caixa Bank to facilitate the prompt release of participant reimbursement funds, as these transfers are often flagged and frozen as potential money laundering.
Several studies, including a 2019 National Institutes of Health survey on trial retention among military service members,{4} have demonstrated a high correlation between timely patient reimbursement and trial retention. These studies underscore the importance for sponsors and CROs to have expert, compliant advisors overseeing the financial complexities of trial participants.
In addition to addressing financial burdens, coordinators help reduce emotional, psychological, and safety barriers to trial participation. One patient coordinator shared, “I look for nice hotel rooms with amenities for families, so the children feel like they’re on vacation and are less likely to focus on or fear going to the trial site.”
Another coordinator recently shared a story about a patient traveling to an appointment in Rio de Janeiro. His car got caught in the crossfire between the army and members of a local gang. The patient, his caregiver, and their driver hid underneath the car until the shooting stopped. Since that experience, the patient coordinator now plans routes that avoid known conflict areas and arranges armored vehicles to transport patients in regions prone to violence.
Providing Linguistic and Cultural Assistance
Patients traveling abroad often need interpreters to explain study requirements and patient obligations during treatment at the trial site. Coordinators from patient support service providers who speak the participant’s native language can assist them from recruitment to patient consent through study completion.
Translation services can mean the difference between life and death for some trial patients. In one example, the family of a pediatric patient living in Israel received special permission from Israel’s Minister of Health to import life-saving medication. The family did not speak the native language of Hebrew, which made obtaining treatment difficult. A tri-lingual patient coordinator who spoke the family’s native language and Hebrew and English could explain the severe condition of the patient and their urgent medical needs to authorities and help find medical personnel to administer the drug safely.
Often being from the same country is not enough; the coordinators need to be local to the patient. The country of Spain, for example, has four official languages—Spanish, Catalan, Basque, and Galician. One coordinator shared, “When participants know their coordinator is local, it makes the connection stronger.” However, building solid connections extends far beyond language proficiency. Studies also suggest that among other trust-based factors, “understanding cultural and social dynamics of the population under study prior to investigation” increases trial retention.{5}
Anticipating the medical needs of patients and helping them navigate the dynamics of the healthcare market are also essential for trial participants around the world. A patient from Ukraine living in Poland needed a specific treatment typically offered free for Polish citizens, meaning there was little to no market for private payers. A patient coordinator called healthcare facilities throughout the country to track down a provider willing and able to provide the necessary treatment.
Guiding Patients Through Pandemic-Related Restrictions
At the height of the COVID-19 pandemic, travel restrictions changed rapidly and varied greatly between countries. Many sponsors and CROs found themselves unprepared to conduct global clinical trials amid the fluctuating restrictions. Investing in additional resources such as patient support services helped them retain study participants while maintaining trial integrity.
Patient coordinators prepared trial participants and families for potential travel issues and managed daily changes in guidelines impacting travel, lodging, visitor policies, and vaccination recommendations. One European patient planned to fly to Spain for a study visit, but air travel and public transportation were not viable due to COVID-19. To ensure she made it to her visits, her patient coordinator scheduled two extended private car trips and arranged overnight accommodations for both the patient and driver.
These examples represent a glimpse into the challenges presented by cross-border travel. Understanding and proactively managing financial, emotional, linguistic, cultural, and pandemic-era barriers allow participants of all income levels, ages, and locations to participate in clinical trials. This assistance, in turn, enables trial sponsors and CROs to boost recruitment, retention, and population diversity. As trials increase the need for cross-border travel, patient support services will play an increasingly central role in successful clinical trial outcomes.
References
- https://www.fda.gov/files/drugs/published/2015—2016-Global-Clinical-Trials-Report.pdf
- Clinical trials and their patients: The rising costs and how to stem the loss | Pharmafile
- https://credevo.com/articles/2019/12/15/rare-diseases-regulatory-incentives-for-development-of-orphan-drugs-us-europe/
- https://doi.org/10.1016/j.conctc.2019.100353
- https://doi.org/10.1093/her/cyl095
Scott Gray is co-founder and CEO of Clincierge, a provider of patient support services for clinical trials. Since 2015, the company’s patient coordinators have managed travel and reimbursements in more than 140 clinical trials around the world.
