Home trial visits are becoming increasingly popular and a key strategy for sponsors because of their ability to expand their geographic reach and bring clinical trials to more diverse populations as well as aid in patient retention. Here is how a niche CRO focused on home trial visits can help.
Decentralized clinical trials have grown in popularity in recent years. Home trial visits have expanded in complexity, and the ability to provide care in the participant’s home has greatly expanded. This approach offers key advantages, including an improved participant experience and reduced dropout rates.
A traditional clinical trial can see a patient dropout rate of greater than 30%. Sponsors are implementing DCT strategies to mitigate this risk as the average cost to recruit one patient for a study is greater than $6,500, and the cost to replace a patient is equivalent to nearly $20,000. Various factors impact the high dropout rates for traditional clinical trials, but one of the major contributing reasons is the burden on patients from a time and participation perspective. When patients are required to travel to the study sites, they can experience physical, logistical, and financial challenges, resulting in a reluctance to participate in clinical trials as well as an eventual discontinuation.
The landscape of home trial visits has undergone a notable evolution, expanding from simple blood draws to encompassing more intricate clinical care within the home setting, all contingent on the specific protocols of each trial. This shift reflects a growing emphasis on patient-centric approaches in clinical research, aiming to enhance participant convenience and engagement and expanding the opportunities for more flexible patient participants.
Home trial visits aim to alleviate the patient burden by bringing the study directly to the patient’s doorsteps. However, they can also have very nuanced challenges. To have a successful home trial option for your participants, it is critical to have the right home health partner. Working with a niche CRO specializing in this DCT solution is the key to successful service.
Defining a Specialty CRO
A specialty contract research organization (CRO) concentrates on a specific service area of clinical research. The advantage of working with a specialty CRO is their ability to offer customized solutions in a focused service area, such as home health, which often leads to more efficient and effective clinical trial outcomes.
Home health specialty CROs focus on navigating the complexities of conducting clinical research in a non-traditional setting. The advantages of working with this type of CRO are insurmountable. These providers offer the following advantages.
1. Expertise in Home Trial Visits
When planning a decentralized trial, it’s important to have an expert on your team who understands the intricacies involved. An experienced partner focusing on home health fills this role by staying up-to-date on compliance, regulatory and privacy requirements while managing the operational complexities to ensure a well-coordinated process. The ideal partner will also have access to thousands of nurses and providers worldwide to support your study in areas most important to you and your patients.
In addition, CROs and sponsors should consider a provider that can offer strategic insights and historical knowledge of how to best operationalize a clinical trial in the home environment. This can involve eSource, telehealth solutions, specialty couriers, central pharmacy options and equipment resourcing that optimizes the research process while maintaining the integrity and reliability of the collected data.
2. Patient-Centric Approach
When including home trial visits in your study, an overarching emphasis on patient convenience and comfort is a defining principle. Recognizing patient satisfaction is critical to the success of a trial, specialty CROs focused on home health understand the needs of the various patient populations and put patients at the forefront of the service and design. This approach, rooted in understanding and addressing the unique needs of individual participants, holds the promise of substantially enhancing patient retention and satisfaction.
Patient Retention
A pivotal advantage of a specialty CRO’s patient-centric ethos lies in its potential to foster higher levels of patient retention. By allowing participants to engage in the trial from the familiar and convenient setting of their homes or alternative locations such as respite homes, community centers, hotels or other settings, home trial providers mitigate the burdens associated with traditional site-based studies. Eliminating the need for travel to clinical sites, the financial implications of the travel and parking, finding childcare, taking time off work and adjusting other daily routines affords the participants who may have otherwise dropped from the study the ability to continue. The result is a more satisfied and committed patient base that’s more inclined to adhere to the study’s requirements over the entire duration.
3. Access to Diverse Populations
Clinical trial diversity is essential because it helps ensure that medical advancements are relevant, effective and accessible to everyone. Traditional clinical trials have struggled to diversify their patient populations due to various barriers, including:
- Lack of awareness
- Lack of access
- Mistrust by underrepresented communities and populations
Working with a home health specialty CRO can make it easier to diversify the patients in your home clinical trial because you can meet with patients at their homes, which relieves the logistical burden for all types of patients, including:
- Patients who live in remote or rural areas
- Patients without transportation
- Patients who work full-time with little or no vacation time
- Patients without childcare
Specialty CROs play a pivotal role in easing the patient burden, therefore improving your chances of recruiting a diverse group of participants for your study. Through their expertise and patient-centric approach, specialty CROs can provide a more comforting, convenient and satisfying patient experience that ultimately leads to more comprehensive study findings.
4. Decreased Site Workload
In a traditional clinical study, the site is a physical location where clinical research activities occur. The site is responsible for various tasks, such as:
- Patient recruitment
- Patient follow-ups
- Study conduct
- Data collection
- Documentation
- Regulatory compliance
- Coordinating more complicated visits that must occur on-site
Working with a specialty CRO to implement home trial visits helps to offload operational tasks that would traditionally fall on the shoulders of sites. This allows the site to focus on increased recruitment activities and more complex tasks, overall having the potential to increase study recruitment and foster a more patient-centric approach that leads to fewer dropouts.
When a site partners with a specialty CRO, they retain oversight of the home clinical trial. As a result, the site ensures the trial remains aligned with its overarching goals and objectives while the CRO leverages its specialized knowledge to complete tasks efficiently.
Conclusion
In the evolving landscape of clinical research, home trial visits are gaining popularity because of their patient-minded approach and ability to expand the reach to meet the participant’s needs. Partnering with a specialty CRO can improve your study through their added expertise, flexible participant options and access to diverse populations, all while decreasing the site’s workload.
Firma is a nimble specialty CRO laser-focused on delivering solutions for home trial visits. With specific knowledge of state, regional and country regulations, we have the unique home health knowledge you need to succeed. We would love to chat about your study and therapeutic area. Please contact us to start the conversation.