Author: ClinEdge Staff
A Chat with the Expert
With the current surge of the Delta COVID-19 virus strain it is likely that in-home clinical trials will continue to take place. In fact, moving some trial site activities into patients' homes has been shown to increase recruitment by 60% or more, and it typically maintains patient retention at over 90%. In light of the recent shift, we sat down with our very own Associate Director of Integrated Trial Solutions, Charlie Small to discuss where to start, what to expect, and future trends with in-home trials.
Q: What are home trial services?
A: There are many “buzzwords” being used throughout the industry to describe remote study conduct. “Remote clinical trials”, “Decentralized Trials”, and “Virtual Trials” are just a few examples of our attempt to properly portray this new model for remote study conduct. At ClinEdge, we prefer to specify home-based studies as the implementation of home clinical trial services to separate this model from other types of studies. To facilitate a home-based clinical trials, home trial services can include any or all of the following: - Patient or caregiver training and education - Homecare provider identification, onboarding, and training - Study drug and device shipping - Lab sample collection, preparation, packaging, and shipping - Remote study procedures at-home - Patient accountability and compliance
Q: What is needed and who is involved with in-home trials?
A: The most important component of a home trial is ensuring that we are implementing services at the site-level. At the end of the day, patients are mainly engaging with the physician at the site on the day of screening and randomization at minimum. Depending on whether the home trial is required or at the investigator's discretion, there can be several different players supporting home visits. At minimum, each site or patient requires a dedicated home health care provider be assigned for the duration of the study. The provider must be onboarded, trained, and managed as a clinical research professional just as any other role player on the delegation of authority. Compliance is critical in this component as the regulations around the world are extremely diverse relating to home trial conduct. Once you have your nurse activated on your study, we need to know how to get study materials to and from the patient's home. It's important to leverage a trusted partner in the medical specialty courier space to remain compliant in the delivery of IP, equipment, or biological specimens. Lastly, and perhaps most importantly, it is critical to centralize communication through a provider to coordinate complex home trial activities. In keeping with the theme of patient centricity in studies, a "Quarterback" is essentially what we are missing in the coordination of home trials - one main point of contact for patients and sites to leverage. With studies moving away from the site, it's going to be crucial to streamline the process as much as possible for the patient to have a pleasant experience on the trial.
Q: When does an in-home study make the most sense? When does it not?
A: There are many factors that may drive a sponsor to choose to go the home trial route. The first relates to patient recruitment - which is highly dependent upon the nature of the patient's indication. Studies show that while 70% of patients say they are willing to participate in a clinical trial, only 30% actually do come into the site for randomization. The problem here is one of burden. Outside of the typical reasons for non-participation or drop out (discontinuing current medications, as an example), clinical trials are burdensome for patients. Studies can be long, drawn out, cumbersome experiences if the patient is required to come into the site several times per week. When you add in the out-of-pocket expenses and travel incurred, we are in a tough situation. Studies that require more than one site visit per week could benefit from a home trial model, however this is also highly dependent on the nature of the study visits. While home providers are trained to perform their duties just as any other site staff, they are still limited based on the environment that they are treating subjects in. Home visits should be limited to what home providers can logistically and legally conduct. Another justification for initiating home trial services into a study is the patient experience. Some patients are immobile, without transportation, or just too debilitated by their condition to make it over to a site a few times a week. For these patients, we highly recommend incorporating a patient-centric model that incorporates home visits, travel support, or a combination of both. Home study visits do not make sense for any study that requires that investigator specifically to conduct complex procedures, such as acute care, in-patient procedures, or procedures that must be made within an extremely short time frame based on certain events.
Q: Where do you see in-home clinical trials going in the future? Could you discuss the current trends?
A: From my own perspective, home and remote clinical trials are only going to increase over the next few years. The team at ClinEdge has vast industry experience in addition to research and client feedback, and what we are seeing is the clinical trial industry rapidly adopting several new strategies to make clinical trials as patient-centric as possible. And it's this emphasis of patient-centricity that is ultimately going to drive innovation in research and allow for more patient populations to participate in studies. Post-COVID-19 we have seen an significant increase not only in the home nursing space, but in the development of virtual trial models as well. In 2020 and now 2021, many of our current partners have adopted and offered a home trial visit option to allow for continuation of their global trials with sites closing or patients being in "lockdown". This year, we are continuing to see an increase in the Home Nursing/Travel option as a mitigation strategy in studies. Not only are we seeing our clients adopt the home trial strategy, but we're even seeing clinical trial protocols with remote/home visits built-in to the schedule of events to support enrollment. Looking forward to the future, building clinical trials with the ability to have a blend of site/home visits will require home trial services to be a critical portion of trial conduct. We anticipate this to continue to grow with the demand of digital clinical trials which is expected to grow over 50 to 100% over the next few years.
ClinEdge's Home Trial Services
With our robust Home Trial Services capabilities, ClinEdge expands the reach of the clinical trial by bringing the trial directly to the patient. Schedule a meeting with us and learn how we can help you reach the unreachable.