Modernizing Clinical Trials in 2023 with Patient Centricity

By Scott Gray, CEO, Clincierge
Twitter: @clincierge

Patients suffering from chronic illness are often eager to participate in clinical trials with the hopes of finding a more effective treatment for themselves and others with their condition. This is especially true in the case of rare diseases, as these trials are often seen as a patient’s only opportunity for treatment. Unfortunately, various logistical, financial, and emotional barriers, like geographic location and travel-related costs, prevent patients from enrolling in trials and accessing life-changing medicine. Because of this, patient recruitment and retention continue to be challenges for the industry despite the best efforts of Clinical Research Organizations (CROs) and pharmaceutical trial sponsors.

From selecting clinical sites to enrollment, study monitoring, and overseeing the resulting data, a trial’s path from initial design to execution and completion is extremely complex. While site staff and researchers focus primarily on the medical and scientific facets of the trial, patients and their caregivers are often expected to manage the logistics related to trial participation themselves. This oversight often includes securing flights, hotel accommodations, and ground transportation, navigating the reimbursement process for travel and daily expenses, and arranging temporary relocation for themselves and their family.

Despite the trial process being a foundational step in transforming rigorous clinical research into healthcare advancements, nearly 80% of clinical trials fail to finish on schedule, with 20% delayed six months or more. While the reasons for these delays can vary, 85% of studies cannot retain enough patients, with more than two-thirds of trial sites failing to meet targeted patient enrollment numbers.

While trial efficiencies have steadily improved over the last decade, logistical burdens placed on the patient continue to cause recruitment and retention to be significant issues. Clincierge recently commissioned an independent study of patients and caregivers who had participated in a clinical trial. Our research partner found that 87% of patients said participating in a trial was stressful for themselves or their families. A patient-centric trial model can significantly reduce participation stress while increasing retention and improving trial outcomes. CROs and pharmaceutical sponsors can improve trial efficiency by prioritizing patient engagement, embracing digital transformation, and investing in supplemental patient support services.

Making Patient Engagement a Priority

Understanding what creates a quality patient experience offers trial sponsors and CROs an advantage in today’s competitive drug development landscape. Not only can prioritizing patient engagement improve enrollment and increase retention rates, but it can also lead to more diverse study participants.

The recruitment of diverse populations for participation in research studies has been a long-standing issue within our industry. According to a report from the FDA in 2020, 75% of American clinical trial participants were white, with the remaining 25% made up of minority groups such as Blacks, Asians, Hispanics, and Latinos. This lack of diversity is rooted in a deep distrust in the pharmaceutical industry. Those within specific populations link this lack of trust to past ethical breaches, like the 1932 Tuskegee Syphilis study in which researchers withheld treatment from black men to study the course of the disease.

Recruiting diverse populations is only the first step to a successful clinical trial. Participants must be supported throughout the study and remain engaged throughout completion to be represented in trial outcomes. For this reason, it is essential to promote the benefits of participation and provide direct support to patients and their caregivers throughout a study by building a relationship of trust between the patient and other trial stakeholders.

One significant aspect of patient engagement is ensuring clinical site staff keeps their patients informed and educated on what is happening now and what will occur later in the trial process. In an independent study from Clincierge, approximately 80% of patients surveyed said they experienced feelings of uncertainty and anxiety throughout the trial. Open communication and transparency from site staff and researchers can aid in alleviating the apprehension felt by trial participants.

Embracing Digital Transformation

While healthcare and technology have always gone hand-in-hand, the COVID-19 pandemic forced the industry to make room for innovative digital processes. Remote and mobile technologies have made it possible to continue clinical research and prevent the interruption of drug development programs despite the emergence of social distancing practices and travel restrictions.

Decentralized trials (DCTs) were universally adopted throughout the pandemic and proved effective for CROs and pharmaceutical sponsors. This trial structure involves options like wearable medical devices, telemedicine, home visits, and local healthcare providers and laboratories in place of traditional site visits to manage drug administration and data collection. These solutions come with various benefits, including higher data quality and a more convenient and improved trial experience for the patient.

Embracing technology for DCTs can significantly reduce some barriers resulting in low enrollment and high drop-out rates. Because there is no central clinical site location, patient populations who otherwise might have been unable to participate due to financial, geographic, or other personal challenges now have the opportunity to obtain new treatments for their disease.

In addition to technology encouraging greater participation and more robust data collection, it can also be used as a form of patient engagement. Wearable or portable medical devices can be a primary channel for sharing important information between participants and trial sponsors. Patients can receive important announcements from the comfort of their homes, as well as updates on the current status of their trial, next steps, and discoveries related to their medical condition.

Digital transformation combined with meaningful face-to-face connections between patients and the clinical site staff will continue to improve the patient experience as we move into 2023 and beyond.

Investing In Supplemental Patient Support Services

Given the various obstacles facing clinical trial participants, CROs and trial sponsors should seriously consider investing in a patient concierge services provider to improve trial efficiency while increasing diversity and retention rates. Much like a hotel concierge, a patient concierge manages all logistics of study participation. These services include:

  • Itinerary planning (flight and rail tickets, hotel accommodations, ground transportation)
  • Reimbursements for meals, incidentals, mileage, tolls, and parking
  • Wage reimbursement
  • Translation services
  • Visa and passport assistance
  • Long-term housing and relocation services

In addition to managing trial logistics, the patient concierge continuously provides support to participants and their caregivers, allowing them to feel more comfortable and secure throughout the duration of a trial. This support allows the patient to focus on their treatment and the caregiver to focus on assisting the patient while easing the path to trial completion for both. Ideally, these coordinators are local to the patient, live in their time zone, speak their native language, and understand their local nuances.

In an independent study from Clincierge, 95% of patients and 98% of caregivers said having a single point-of-contact to assist them in the clinical trial was crucial. Without the role of a patient concierge, participants do not have the luxury of this designated shoulder-to-lean-on. When a pharmaceutical sponsor or CRO chooses to include this service in their trial protocol, they put the patient’s needs first and show their commitment to bettering the overall trial experience.

The Bottom Line

In order to accelerate drug development and bring new treatments to the market, the patient experience must be at the center of clinical trial design moving forward. Pharmaceutical companies can utilize the above efforts to improve patient recruitment, increase retention rates, and expand the geographical and socioeconomic reach of the available participants.