How different site models fit different types of diagnostic clinical trials
Modern diagnostic studies have their own unique set of challenges and requirements that can call for different tools and services. From oncology diagnostics, to at-home diagnostic tools, to diagnostic tests that require sample collections, each type of diagnostic study needs a site model that can encompass all the capabilities necessary for trial execution. This means having the right technology-driven services, eClinical platform features, and data-collection capabilities to deliver diagnostic trials in a setting optimal for achieving the desired results. Depending on where and how a diagnostic trial needs to be executed, understanding the optionality in clinical trial site models is an important step in planning, designing, and executing an effective diagnostics trial.
Some of the site model options that exist are:
Virtual site models
A fully virtual site model leverages 100% remote trial design through the use of an eClinical suite which includes a user-friendly platform, telemedicine, eConsent, ePRO, and eCOA capabilities along with an assigned PI to the virtual site. This type of diagnostic site model is intended for studies that do not require in-person site visits, studies that are in the early stages of design and start-up, and/or studies that are actively looking to add a new site.
This type of diagnostic site model is ideal for studies around acute illnesses such as STIs or infectious diseases like COVID-19. In these instances, patients aren’t likely to seek prestigious study centers when they are experiencing symptoms, in-fact today, many patients turn to telemedicine and at-home tests to diagnose and treat these common infections and illnesses.
This fully virtual site model uses digital recruitment tactics to find highly qualified patients where they are, inform them of the study, prescreen them, and offer eConsent to allow for a fully virtual enrollment. This site model includes shipping at-home tests directly to patients to self-administer and send to a lab for analysis allowing sponsors to view results in real time. Patients are able to receive the care they need without having to travel. Fully virtual sites are flexible enough to find ideal, highly-qualified patients where they are and bring the trial to them while also being able to capture high-quality study data and deliver patient-centric care.
Studies using virtual sites can also incorporate home healthcare to allow for physical sample collection without requiring patients to travel to in-person sites. By utilizing an eClinical platform including telemedicine and ePRO and eCOA capabilities, a PI assigned to the virtual site, and mobile nursing/phlebotomy services, diagnostic studies can overcome the need to collect patient samples at physical site locations.
This flexible site model incorporates both virtual and mobile decentralized trial capabilities. Diagnostic studies that are in the early stages of study design, at start-up, or that are actively looking to add a new site to their study can implement this type of site model to minimize unnecessary in-person site visits and travel for patients. This particular site model is ideal for diagnostic studies where data collection can be done via mobile nursing or phlebotomy. .
As an example, Curebase implemented a virtual site with home healthcare model for a Lyme disease diagnostic study that needed to reach patients in endemic regions where traditional sites were few and far between, making recruitment difficult. The implementation of virtual sites allowed recruitment to be done online and with local practitioners while follow-ups could be completed with mobile phlebotomy services and through telemedicine providers. Curebase’s advanced telemedicine capabilities allowed practitioners to analyze ‘bull’s eye’ rashes and take clear visual snapshots. Mobile phlebotomists were deployed to collect blood samples from patients at home during a specific window of time and patients were able to schedule these appointments directly on the platform.
Hybrid site model
A hybrid site model allows diagnostic studies to incorporate both virtual and mobile technology trial capabilities, as well as in-person site visits conducted with a local provider. This model can collect patient data both on-site and via virtual/mobile healthcare. The technology-centric aspect of a hybrid site model removes burdens on on-site staff by implementing easy-to-use technology for patients to complete consent, prescreen, and enroll via their mobile devices. This model can include the incorporation of a full eClinical suite, including telemedicine and ePRO, and eCOA, mobile phlebotomy/nursing services, along with a PI assigned to this virtual site. This model utilizes the necessary aspects of both virtual and in-person sites to ensure all diagnostic study needs are met.
Community site model
With community site models for diagnostic trials, all patient participation takes place at a local provider or community clinic. This type of model involves in-person activities yet is infused with technology-driven services to optimize the study. This type of site model works well for diagnostic studies without complicated procedures where most, if not all, visits can be conducted by local practitioners and study data can be collected on-site from site staff and uploaded into an eClinical platform.
This model utilizes a network of community care clinics in desired regions alongside validated virtual tactics to recruit, prescreen, and enroll patients. In this model, site staff have access to an eClinical suite with a Site Portal including eConsent, eSource, and scheduling capabilities to be able to move patients through the enrollment process efficiently. This type of site model is ideal for diagnostic studies where very little follow-up is required, and patients can simply arrive at a community site, participate in the study, and return home having completed their participation.
An example of this type of model would be a COVID-19 diagnostic study where Curebase activated local drive-through COVID testing centers as trial sites. When patients drove up, they were presented with the option to participate, consent and enroll via their mobile device by scanning a QR code while in line. Site staff were notified of patients who had enrolled and would administer the rapid test. In total, 383 completed Covid-19 tests were collected between the months of October to November 2020. This study had 40% greater diversity than traditional trials due to its decentralized nature, and the test received FDA Emergency Use Authorization in December 2020.
Having the unique ability to incorporate necessary in-person, virtual, and at-home services and capabilities into any diagnostic study gives sponsors the opportunity to optimize their study design more efficiently and reach their study goals. There are many ways in which Curebase’s site models can be utilized for diagnostic trials. To learn more about the site models addressed above and additional site models, take a look at Curebase’s diagnostics offering.