Clinical research plays a pivotal role in advancing medical knowledge and transforming healthcare practices. It serves as the cornerstone to diagnose, treat, and prevent illness while improving the quality of human life. Not only does clinical research validate the safety and efficacy of new therapies, but it also deepens our understanding of disease mechanisms and patient responses. Research is a vital channel for translating scientific discoveries from laboratories into real-world applications, bridging the gap between theory and practice.
Despite the clinical trial process being a foundational step in developing potentially lifesaving treatments, the path from initial design through study execution and completion is long, arduous, and often rife with obstacles. As a result, patient recruitment and retention continue to be pressing issues for trial sponsors and clinical research organizations (CROs). Patients experience various emotional, financial, and logistical burdens preventing them from enrolling and participating throughout the duration of a study.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Research suggests nearly 80% of clinical trials fail to finish on schedule, with 20% delayed six months or more. While the reasons for these delays vary, more than two-thirds of trial sites fail to meet targeted patient enrollment quotas, with 85% of studies unable to retain enough patients through completion. The impact of poor patient recruitment and retention on the strength of clinical research should not be overlooked by trial administrators.
Addressing these roadblocks head-on will improve future trial efficiency and bring new medications and treatments to the market faster. Below, we outline the cost of these roadblocks for trial administrators and offer practical solutions to combat common pain points.
The “why?” behind poor recruitment and retention
As mentioned above, poor recruitment and retention often result from perceived and actual burdens patients face to trial participation. Identifying an eligible patient is only the first step in the process. Study staff must ensure patients become engaged and successfully complete the trial.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Initially, several financial aspects require consideration. Individuals may have to take time off work for treatment at clinical sites, and the expenses linked to the necessary travel can be substantial, especially for trials requiring cross-border travel. Even if these costs are eventually reimbursed, patients might lack the initial funds required to participate. Similarly, travel to unfamiliar locations can prompt logistical concerns, like: How will I get to the trial site? Do I have to drive myself? Can I bring my child with me? Where do I park, and how much will it cost each time? These unknown questions alone are enough to discourage participation.
On top of financial and logistical concerns, many emotions come into play when choosing to participate in a clinical trial. Suffering from chronic illness can be complicated enough on its own, and volunteering as a research participant can be unnerving and lead to added stress. In an independent study on rare disease trials, 83% of patients reported feeling excitement related to participation, while also reporting feelings of anxiety, uncertainty, and frustration.
When a trial fails to enroll and retain enough patents for successful completion, trial administrators face significant financial losses. However, the cost for patients in need of these life-changing or sometimes lifesaving treatments is immeasurable.
The value of patient participation
The costs associated with developing a new drug are substantial, with estimates fluctuating. The Tufts Center for the Study of Drug Development has estimated this cost to be around $2.6B, although a study published in JAMA Internal Medicine suggested a lower average of roughly $1.3B. Understandably, each trial’s costs vary depending on variables like the number of patients required, trial duration, site locations, and more.
Historically, clinical trials seeking U.S. Food and Drug Administration (FDA) endorsements were estimated to have a median cost of $19M, with pivotal Phase III studies for newly FDA-approved drugs incurring a median cost of $41,117 per patient.
Regardless of the range of estimates, a unique perspective should be considered when we contemplate these numbers from an administrative standpoint. Instead of regarding patients as expenses in the context of clinical trials, it is more sensible to consider their participation’s value.
To illustrate, take the case of a widely recognized medication used in treating multiple sclerosis, which has been on the market for six years. The treatment garners frequent prescriptions, and the trial sponsor has reaped substantial revenue and return on investment from their research, accumulating a total income of approximately $17.5B as of last year. The clinical trial for this drug consisted of 1,656 patients. In essence, each trial participant contributing to the drug’s market entry translates to over $10.5 million in revenue.
With price tags this high, it is easy to understand how detrimental trial delays or cancellations can be from a financial standpoint. Trial sponsors, CROs, and clinical site administrators already have their hands full dealing with the process’s research and data collection portion, and recruitment and retention issues only add another layer of complexity. Since these issues often stem from poor communication or patient experience, keeping the patient at the top of mind throughout trial design will ensure efficient and successful research with engaged participants.
Investing in patient concierge services
Investing in comprehensive patient concierge services keeps trial administrators on track by removing the burden of logistical support and improving the overall participant experience, making dropouts and trial delays much less likely. Offering patient support services throughout the duration of a trial can drastically improve its efficiency, allowing study administrators and sponsors to achieve improved results at a faster speed.
Similar to the role of a hotel concierge, a patient concierge oversees the practical aspects of study participation. These services include managing hotel accommodations, air/rail ticketing, ground transportation, incidental reimbursements, and assisting with visas and passports for cross-border studies. Ideally, a patient concierge should be located in the participant’s home country, proficient in their native language and that of the trial, and easily reachable throughout the study. This person acts as a single point of contact for the patient throughout the trial, building a personal connection while understanding the nuances of their experiences and the region where the trial is conducted.
In a study on rare disease trial participants, 95% of patients and 98% of caregivers said having a single point of contact to assist them throughout the clinical trial was crucial. The designated patient concierge acts as emotional and logistical support, understanding their needs and making decisions accordingly. When study sponsors and CROs choose to include this service in their trial protocol, they put the patient’s needs first and show their commitment to improving the overall trial experience.
The bottom line
Employing these resources is a win-win for patients, study sponsors, and CROs. In order to accelerate drug development and create more streamlined and economical trials moving forward, the patient experience must be at the center of trial design. Utilizing these customized services will improve patient recruitment, increase retention rates, and protect clinical research from costly mistakes.
Photo: Deidre Blackman, Getty Images
Scott Gray is the co-founder and CEO of Clincierge, a provider of patient support services for clinical trials. Since 2015, Clincierge patient coordinators have managed logistics and reimbursements in more than 300 clinical trials worldwide
