The Future of Home Healthcare in Clinical Trials
During the COVID-19 pandemic, sponsors and research institutions adapted to new approaches to clinical trials, deploying technology and other tools such as remote monitoring, telemedicine, and home healthcare visits, which has helped to accelerate the evolution of decentralized clinical trials.
Sponsors and research institutions have become less rigid in their research processes and policies, all while maintaining Good Clinical Practice standards.
There is some evidence that not all patients would prefer home visits over clinic visits, with a recent survey finding that only 51% of 1,129 potential research participants favored home visits for future trial participation.
A key step to advancing a patient-centric approach will be addressing patient visit compliance concerns, ensuring that proper treatment is administered, with the potential of increasing patient retention.
Four strategies that can help reach the next frontier of a patient-centric approach:
- Enhancing community engagement to boost awareness of clinical trials and of the fact that patients can participate in some trials with minimal or no need to leave their homes. Meeting the patients where they are may be particularly attractive to underserved populations and helps to alleviate financial and travel burdens. Helping sites and patients understand the benefits of decentralized participation is key to overcoming this barrier. This understanding may allow patients to participate in research safely, ethically, and with the highest scientific integrity and validity.
- Advancing online recruitment through social media, which are widely used by most populations, including the underserved. Social media can be used to highlight disease burdens in particular populations and promote clinical trials as a care option. Addressing “digital deserts,” where broadband internet access is unavailable, will be critical to reaching all populations; this may be an area where sponsors can provide support.
- Building a broader understanding of how technologies such as wearables, sensors, and electronic patient-reported outcome (ePRO) devices work in the real world so that these can be used with confidence to gather data remotely. Principal investigators need to take accountability for third-party vendors going to patients’ homes in cases where home health can be a technology-driven risk. The U.S. Food and Drug Administration and Clinical Trials Transformation Initiative support virtual technology to improve clinical trials and develop new opportunities that incorporate mobile technology for all kinds of trials.
- Revising sponsor’s standard operating procedures (SOPs) to be more flexible to this new way of working. A revised, hybrid version of site and sponsor SOPs that allow for remote monitoring, eConsent, home health/virtual patient visits, etc., would accommodate decentralization of many clinical trials. Process mapping is also critical to supporting this endeavor. Additionally, protocols that are written in such a way that minimizes the patient travel and financial burden can be implemented where non-interventional procedures can be done virtually or at a patient’s place of residence, consequently simplifying the patient engagement process and benefitting the research process.