How real-world flexible site models make diagnostic trials more efficient

Every clinical trial presents its own unique set of challenges, whether it's geographic reach, specific recruitment needs, expedited timelines, or follow-up management. Having the right partners that can offer flexible solutions to directly address sponsor concerns and study challenges with a modernized approach can make a substantial difference in trial efficiency. 

Technology-driven diagnostic CROs that utilize virtual sites and local care networks offer diagnostic trials flexibility in trial design. Diagnostic clinical trials tend to be decentralized by nature, positioning them well for designing highly efficient studies. By utilizing flexible site models and a fit-for-purpose technology platform, diagnostic sponsors can design trials that optimize patient recruitment, overcome geographic limitations, and capture data from real-world settings. 

Why are flexible site models important for diagnostic studies? 

In a diagnostic study, particularly for infectious disease, it is critical to pinpoint geographic hot spots of infection and activate local sites in those regions to reach viable patient pools. Because diagnostic trials often require participants to be actively experiencing symptoms or require diagnosis within a specific window of time, activating virtual sites or community clinics is an efficient means of reaching the right participants at the right time, while also reducing patient burden. 

Any variation of virtual, hybrid and in-person sites can be built into trial design giving sponsors the flexibility to shape recruitment and site activation strategies to the specific needs of an individual study. Additionally, diagnostic studies can benefit from collaborative contract research organization (CRO) services, purpose-built technology for real-world data collection, and much more. This type of all-in-one, yet customizable, approach enables faster studies, greater cost savings, and better patient engagement.

In Practice

Adaptive Biotechnologies was looking to study the effectiveness of a diagnostic test for Lyme Disease. For this particular study, a virtual site model enabled Adaptive to reach patients in endemic regions where Lyme Disease was prevalent. In addition, recruitment for the study was done online and at local sites to further assist in targeting viable patient populations. This technology-driven decentralized clinical trial site and recruitment model allowed for virtual care and telemedicine capabilities that lifted the burden on in-person follow-ups. 

Without this specific site model, patients would have been required to travel to research centers to enroll in this study if they suspected they had  Lyme Disease. Due to the nature of the disease, the likelihood that patients eligible for the study would seek out a research center for care is slim. Furthermore, based on the time-sensitive recruitment parameters, this study needed to reach patients in specific windows of infection and conduct initial exams as soon as possible With this virtual site model, patients were able to enroll online or at their local care facility where they were likely to go to receive treatment anyways. 

Technology-driven diagnostic CROs, like Curebase, can offer site models that utilize pre-existing relationships with local sites and community health centers to use in future studies. This enables Curebase to rapidly enlist participants and move from trial startup to site activation to closed enrollment in a more accelerated time frame. This approach allows for quick pivots in site location which can be extremely beneficial in studies where infection rates fluctuate through regions. 

How digital tools enable efficient diagnostic studies

 Offering comprehensive training for site staff while also equipping site staff with all necessary devices/tablets and technologies needed to carry out their roles within the study helps enabled research-naive site participation  This allows local care clinics and community health centers with limited resources, staff, and little experience participating in clinical trials to do so without adding large burdens to their day-to-day operations. Making site activation a more seamless process for a variety of different decentralized site models.

Additional decentralized or virtual software features such as enabling remote sample collection via mobile phlebotomists or shipping diagnostic testing kits to sites or directly to patients' homes and then shipping directly to culture labs can increase the ease of sample and data collection.  These capabilities, in tandem with a platform built around patient and provider experience to simplify site data entry and to reduce patient dropout rates, allows even the most research-naive sites to join clinical trials. 

In Practice

At the peak of infection rates for COVID-19, Curebase ran a decentralized clinical trial with Clip Health for a COVID diagnostic rapid test. Local care centers were activated as hybrid sites in areas of high infection that already had testing centers set up to administer nearly 400 Clip COVID diagnostic rapid tests between October to November 2020. The Clip Health study was completed in just two months and the rapid test received FDA Emergency Use Authorization. The rapid EUA approval validates the ability of decentralized site models to reach specific participant pools by activating virtual and traditional sites that reach patients where they are. 

Modernizing diagnostic trials deliver care and bring research to patients where they are in a way that empowers sites and is efficient for sponsors. Curebase offers sponsors an all-in-one yet flexible approach to designing their clinical trial in such a way that they can include the decentralized software features that are the best fit for their study. 

Site models having a technology-driven diagnostics CRO that is well-experienced in designing and executing diagnostic studies is an important part of building an optimized study. Moreover, it is even more important that this partner can provide the tools, technology, and services needed to execute faster more efficient diagnostic studies without extensive integrations with several other third-party vendors to bridge gaps in offerings. A full-service vendor has a  deep understanding of patient and site burdens and fosters strong relationships with sites to collect their feedback and understand how to build a trial that sites can actually participate in while offering the technology and capabilities needed to execute.  

Learn more about utilizing real-world medical settings in diagnostic studies in this whitepaper: Bringing infectious disease studies to patients.