Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts. These high rates are influenced by financial, emotional, and logistical barriers to participation, such as geographic location and travel-related costs, which prevent patients from enrolling in trials and accessing life-changing medicine.
As 2024 gets under way, clinical trial stakeholders are witnessing transformative trends aimed at addressing these pain points. Below are some critical considerations for pharmaceutical sponsors and contract research organizations (CROs) to keep top of mind in the new year.
Building Upon Decentralized Trials
In 2020, study sponsors and CROs relied heavily on decentralized clinical trial (DCT) models to keep existing studies on track and launch new trials while adhering to evolving pandemic protocols. While the popularity of DCTs grew through 2021, many sponsors have returned to a clinical trial site–focus strategy since 2022.
Embracing technology for DCTs can significantly reduce the barriers leading to low enrollment and high dropout rates. Because there are no central clinical site locations, patient populations which otherwise would be unable to participate due to financial, geographic, or other personal challenges now have the opportunity to obtain treatments.
Blending the personalized attention found in conventional trials with the patient-focused features of DCTs represents the optimal strategy for shaping future study designs. This hybrid methodology incorporates the advantages of home care and telemedicine to minimize the necessity for onsite visits, while delivering specialized treatments within the secure confines of a controlled clinical environment. By adopting this mixed approach, the demands on patients and their caregivers are lessened, enhancing the patient experience and improving participant retention rates.
Digitizing the Patient Experience
Emerging technologies provide the opportunity to maximize efficiencies throughout each trial phase. In addition to wearable devices and telemedicine allowing for remote connectivity, opportunities have arisen to digitize how trial sponsors and CROs collect and manage patient data, participant feedback, and treatment administration, including:
- Development of sponsor, site, and patient portals to streamline communication and engagement
- Integrated data management solutions to ensure the seamless flow of information throughout the trial, promoting efficiency and accuracy
- Implementation of advanced payment processing systems to simplify financial transactions, offering a more convenient and transparent experience
Again, this hybrid model of digital transformation partnered with continued face-to-face connection between patients and clinical site staff leads to improvements for the patient experience.
Diversity and Equity at the Forefront
The U.S. Food and Drug Administration will require clinical trial stakeholders, including researchers and sponsors seeking approval for late-stage clinical trials, to submit diversity plans for participants in their trials. Recruiting diverse trial populations increases healthcare equity and enables clinicians to hone their evaluation of treatment outcomes across many different demographics.
While ethnic and racial diversity should be kept top of mind for trial sponsors and CROs, other types of diversity should also be considered, including:
- Gender: Until recently, medicines, vaccines, and other treatment options were primarily evaluated on men. A recent study published in Contemporary Clinical Trials found women have been severely underrepresented in clinical trials and that this is a contributing factor to health inequity.
- Age: Elderly participants are often omitted from clinical trials for many reasons, making it difficult for physicians to determine how a given treatment or medication may affect their older patients.
- Geographic Location: Environmental factors impact quality of life and overall health, so clinical trials should include participants from diverse geographic areas.
- Education Level and Socioeconomic Status: When individuals in lower socioeconomic brackets are excluded from trial participation, researchers cannot fully understand how treatments affect underrepresented cross-sections of society.
Patient Concierge Services at the Heart of Trials
To counter these recruitment and retention challenges, trial sponsors and CROs are adopting a patient-centric approach to trial design. By better understanding a patient’s needs, preferences, and participation barriers, a more efficient and patient-friendly trial model can be constructed, ensuring a more positive overall experience.
Patient concierge services are being integrated to alleviate the burden on trial participants. Much like a hotel concierge, a patient concierge manages all logistics involved in trial participation. Having a concierge level of support makes a trial much less intimidating for patients, their caregivers, and their families. These services often include:
- Itinerary Planning: Flight and rail tickets, hotel accommodations, ground transportation
- Reimbursements: Incidental charges for meals, mileage, tolls, and parking
- Translation Services
- Visa and Passport Assistance
- Long-term Housing and Relocation Services
Submitted by Scott Gray, CEO of Clincierge.