How DCT technology can be leveraged in a long-term follow-up study
Long-term follow-up (LTFU) clinical trials are most commonly structured in two different ways. Some long-term follow-up can be built into a trial protocol from inception such as a 6-month drug study that monitors clinical parameters and the durability of effectiveness for X amount of time.
The other construct, which although not uncommon, may be growing, is a roll-over protocol where every patient that completes the treatment phase of the trial transitions to a roll-over protocol for long-term follow-up. For example,12 studies all researching the same therapeutic intervention in a disease category may have a roll-over protocol that has all participants, from the 12 studies, who have completed the treatment move to a different type of study where they are monitored for safety and effectiveness for a certain period of time.
Endpoints for long-term follow-up may also shift between time-bound or clinical-bound such as a specific clinical value returning to baseline. Some studies may require a clinical test such as an EKG be administered until patients consistently meet a baseline or standard, whereas other studies might need to collect blood pressure from patients every 6 months for 3 years. Typically the requirements and endpoints are defined by regulators.
Despite the variations in how long-term follow-up studies can manifest, the incorporation of technology can drastically alter how these studies are executed, how patients participate, and the amount of manpower and patient hours needed to meet protocols. Running a long-term follow-up study from start to finish requires a significant amount of resources, time, and retention tactics - this is even more so when LTFU lasts over the course of several years. There are many different clinical technologies that exist which can mitigate the heavy burdens and responsibilities on site staff, sponsors, and patients that come with LTFU.
Below is a list of decentralized clinical trial technology and tech-driven services and how they can be leveraged in a long-term follow-up trial.
Flexible Virtual Site Models
Having the ability to choose a site model for a long-term follow-up study that optimizes recruitment and retention is key. By nature, many LTFU trials require a large, diverse patient population over a long period of time, making them suitable for decentralized components, such as virtual site models. These types of models allow sponsors to expand their LTFU trial to any geographic location to reach up to 10x more patients than a traditional site model. With a fully-virtual site model, all patient data in the trial can be collected remotely allowing patients to participate 100% from their homes.
A purpose-built eClinical platform allows patients to participate in LTFU studies virtually by providing an end-to-end user experience. This type of eClinical platform has all the capabilities necessary to run a LTFU study from start to finish guiding participants through the trial while capturing proper patient data at specific checkpoints.
An eClinical platform with the capacity for telemedicine visits allows participants to be properly monitored and schedule visits with care providers if/when necessary. This not only mitigates the need for in-person visits but also supports home-based participation in these LTFU trials, making it more convenient for the patient to stay engaged in a study over a long period of time.
Patient Reminders, Scheduling, and Notifications
eClinical platforms that can offer patient reminders, checklists, and scheduling through text, email, and mobile app push notifications help maintain patient retention over long-term trials. Removing the burden on patients to remember their next steps, schedule their next appointment, etc., makes participating easier so patients are more likely to stay engaged.
The ability to collect and store all the necessary patient data in a LTFU trial is crucial, particularly when the trial lasts several years. Having technology specifically built to capture high-quality, self-reported patient data allows patients to successfully participate in these studies from any location on any device while maintaining data integrity.
Leveraging mobile nurses and phlebotomists for in-person sample collection where applicable mitigates the need for patient travel or unnecessary in-office visits for simple procedures like blood draws without compromising the sample collection. These services make participating in LTFU trials more convenient for patients and give them more optionality in how they participate.
Custom Study Dashboards
Dashboards that take real-time study and patient data directly from ePROs/eCOAs and organize it into trends and insights make it easy for sponsors to remotely monitor their long-term follow-up trials. Custom dashboards can be built specifically for what sponsors are most interested in seeing to ensure seamless participation and maintain high retention rates. These dashboards can also show sponsors where participants are in their journey and which steps they’ve completed in the trial.
The technology and tech-driven services mentioned above are just some of the decentralized components that can be incorporated into your next long-term follow-up study. To learn more about how DCTs can be leveraged in long-term studies check out this article by Jane Myles.