Clinical trials are a foundational step in transforming rigorous clinical research into valuable healthcare advancements. In many instances, participating in a clinical trial may be the only way to secure life-changing or even lifesaving treatments when no other approved options are available. While pharmaceutical companies ultimately seek a return on investment in their research, there is also a human need to be met, contingent upon clinical trials successfully attaining their targeted enrollment, retaining participants through completion, and attaining crucial data milestones. Yet, despite the best efforts of study stakeholders, recruitment and retention continue to be challenges within the industry and the most significant cause of trial delay.
Unfortunately, various emotional, logistical, and financial barriers, such as geographic location and travel-related costs, prevent patients from enrolling in trials and accessing life-changing medicine. Because of these burdens to participation, patient recruitment and retention continue to be challenges for the industry despite the best efforts of pharmaceutical trial sponsors and clinical research organizations (CROs).
With the right tools and resources, sponsors and CROs can take a patient-centric approach to trial protocol design, improving recruitment and retention rates and leading to more successful study outcomes.
Remedying the Burdens to Clinical Trial Participation
While trial efficiencies have steadily improved over the last decade, nearly 80% of clinical trials fail to finish on schedule, with 20% delayed six months or more. While the reasons for these delays vary, 85% of studies cannot retain enough patients, with more than two-thirds of trial sites failing to meet targeted patient enrollment quotas. Identifying a patient to participate in a study is a great start, but ensuring each individual can fully complete the trial is a separate battle.
One of the most significant contributors to patient drop-out rates is the financial burdens associated with trial participation. Patients may need to take time away from work to visit clinical sites and receive treatment in a study, and the cost of travel alone can be significant. Even if these expenses are reimbursed, patients may not be in a position to make the initial payments necessary to begin the trial process. In an independent study by Clincierge, 62% of patients and 59% of caregivers stated that travel-related challenges, and the subsequent financial implications of participation, prevented them from participating in a trial.
There are also many logistical and emotional barriers when traveling to clinical sites, especially in trials requiring cross-border travel. Navigating international travel, particularly for extended periods, requires logistics expertise, a global network, ample time, and incredible perseverance from everyone involved. In addition to travel coordination, documentation (passports, visas, etc.) and health requirements (immunizations, timed COVID-19 testing, etc.) must be accounted for and arranged accordingly.
For example, in a trial targeting a rare pediatric disease, an entire family may need to relocate to a remote trial site in another country. Their relocation might involve visa coordination, prepaid air or rail travel, ground transportation, short or long-term housing, translation and interpretation services, and more. It is easy to understand why a patient and their family may choose to decline the study altogether rather than take on the job of a travel agent, chauffeur, and the many other roles required for trial participation.
Investing in Patient Concierge Services
Clinical site staff and researchers primarily focus on a clinical trial’s medical and scientific facets, leaving patients, caregivers, and their families to manage the logistics of participation on their own. Given the various obstacles facing clinical trial participants, trial sponsors and CROs should consider investing in a patient concierge services provider. The support services these companies provide increase access to and diversity within the study while improving trial efficiency and increasing retention and completion rates. Much like a hotel concierge, a patient concierge manages all logistics of study participation. These services include itinerary planning and ticketing, reimbursement facilitation, visa and passport assistance, and more.
Patient support takes on many forms. In some cases, the assistance means simply having a designated contact for any questions or concerns a participant may have regarding trial design and logistics. When surveyed, 95% of patients said having a single point of contact to assist them in the clinical trial was crucial. Ideally, a patient concierge is based in the same country as the patient, speaks their language, and provides continuous support for the duration of the study. They build a personal relationship with the patient, offering an understanding of the nuances of their experiences and the region where their trial occurs.
Taking a patient-centric approach to clinical trial design and providing patient support services can be an extremely rewarding initiative in the long run from both a business and humanistic perspective. Rather than looking at patients as a cost to clinical trials, why not consider the added value of their participation?
For example, data shows that a popular drug treating multiple sclerosis has resulted in substantial revenue with total earnings of approximately $17.5B. The clinical trials supporting the drug’s initial FDA approval involved 1,656 patients. In other words, each trial participant who enabled the drug to get to market resulted in more than $10.5M in revenue.
The revenue estimate above is a rough calculation, but the figure illustrates the value of patient participation in clinical trials and the potential return on investment upon study completion, drug approval, and entrance onto the market. At the end of the journey, the improved quality of life for the additional patients who gain access to this novel treatment is the reward for clinical trial participants and study stakeholders.
The Bottom Line
The patient experience is inextricably linked to increased recruitment and retention rates. As the pharmaceutical industry learns the value of putting patient experience at the center of clinical trials, outcomes will improve for patients and study stakeholders. Improving patient experience expedites the clinical trial process, making lifesaving and life-enhancing therapies available to a larger group of patients more quickly and allowing healthcare to maintain its original goal—caring for the health and well-being of patients around the globe.
Scott Gray is CEO of Clincierge.