Clinical trials technology specialist Paradigm Health has introduced a new, late-phase clinical evidence generation platform, which sets out to streamline the gathering of prospective clinical evidence.
The technology, which Paradigm has called SPIRE, is designed to help trial sponsors to more efficiently approach label expansion and post-marketing commitments by simplifying post-approval studies and reducing administrative burden.
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It acts by facilitating data-driven trial design, while allowing for smarter site selection informed by care patterns and site capabilities, Paradigm’s CEO, Kent Thoelke, tells Clinical Trials Arena.
“By combining patient recruitment, study design and electronic health record (EHR)-integrated data capture across over 160 research-ready community and academic sites in the US, SPIRE enables sponsors to run studies that place a lower burden on research staff,” Thoelke adds.
Paradigm debuts SPIRE amid the company’s wider efforts to incorporate clinical trials into routine care, as community and rural-based patients are often underrepresented in traditional post-approval studies.
According to Thoelke, this is primarily due to the administrative burden late-phase research can have on smaller, community-based centres. “The current research model often forces sponsors to choose between speed, rigour and representativeness because there is a limited number of sites that can take on this burden,” he comments.
Paradigm hopes that its technology platform, which includes SPIRE and others, will quell this burden by offering study conduct support across the entire timeline – including site selection, startup, enrolment, data management, safety and closeout.
Overcoming challenges in the post-approval setting
Currently, post-approval studies pose several challenges for the industry, with one of the most prominent being patient recruitment and retention.
“Clinicians have little incentive to enrol patients in a study if a therapy is already on the market and can be accessed directly,” Thoelke says.
This is compounded by the use of EHRs in real-world studies that are often not designed for research, adds Thoelke.
To overcome these challenges, Thoelke says that there needs to be a focus on creating research-enabled clinical workflows, which means that community and rural sites can participate in clinical trials without adding administration burden.
“More research sites translates to a broader patient population, and the resulting data will offer more robust and actionable insights into how therapies work,” Thoelke concludes.
