The landscape of clinical research technology has witnessed a seismic shift in 2023, with research sites gaining unprecedented power in the clinical research value chain. As sites grapple with the backlog of clinical trials and ongoing capacity challenges, technology automation has emerged as a crucial ally.
Battling Capacity and Employee Turnover with Automation
One of the most prominent challenges faced by research sites is their limited capacity for trials, compounded by high employee turnover rates. In 2022, a surge in capacity issues was observed, with many sites reaching their limit and unable to take on additional trials.
This crisis has necessitated the adoption of technology automation to expedite document and data collection processes, ultimately allowing for more efficient study completion.
Automated Workflows and Integrations Amplify Trial Capacity
To win over the most sought-after research sites, sponsors are now focusing on enhancing automated workflows and integrations. With 85% of sites already utilizing an eISF platform, 95% employing an eSource platform, and 63% incorporating an eConsent platform, it is imperative for sponsors to provide the platforms that sites lack or find dissatisfying. Ensuring seamless integration with existing platforms, including electronic health records systems (EHR), is equally important.
High Site Adoption Rates are the Target
The clinical research industry is in dire need of technologies that are readily adopted by sites.
Presently, 30-40% of pharma and biotech sponsors are not content with the site initiation process for their tech. Conversely, less than 10% of sites believe that the technology provided by sponsors or contract research organizations (CROs) meets their requirements.
This gap highlights the need for improved implementation processes and user-friendly platforms that align with the workflows of research sites.
A Shift from Decentralized to Hybrid Clinical Trials
The onset of the Covid-19 pandemic saw a surge in decentralized clinical trials (DCTs), which range from fully virtual trials to hybrid trials combining site visits and online data submission.
However, fully virtual trials have waned in popularity due to concerns over data privacy, compliance, and the inability to cater to patients requiring complex therapies. The hybrid trial model, which blends site visits with technology, is now gaining traction as the preferred way forward.
Frontier Sites Enhance Access to Clinical Trials
Frontier sites, such as pharmacies, community clinics, and doctors’ offices, hold the potential to democratize access to clinical trials, especially for economically disadvantaged or underrepresented patients.
However, these sites often lack the necessary technology and experienced staff for regulatory documentation and data collection. To overcome this hurdle, infrastructure investments are essential, including built-in compliance tools, collaboration tools, and communication tools to foster a harmonious relationship between sponsors, CRO sites, and frontier sites.
Transforming Clinical Trials
The evolution of clinical trial technology must be centered around supporting research sites. By equipping sites with user-friendly, intuitive technology that alleviates the burden of document management and data entry, the clinical trial landscape can be transformed, ultimately accelerating the research process resulting in progress.