The company that provides patient-centric data analytics has added the PAS that will enable clinical trial sponsors to identify the most effective investigators.
The PAS metric derives from the Phesi Digital Patient Profile (DPP), using real-world data from more than 95 million patients and over 500,000 clinical studies from Phesi’s platform. PAS can be applied to improve investigator and site selection, reduce protocol amendments, and save costs by eliminating activation of non-performing sites.
“For too long, the clinical development industry has accepted and absorbed the financial burden of unnecessary protocol amendments and poorly performing sites. These often-excessive costs and the significant impact on time to market no longer have to be part of life,” said Dr Gen Li, president and founder of Phesi.
“By using contextualized data for precise site and investigator selection, unnecessary protocol amendments and CRO change orders can be zeroed completely. We know that poorly performing sites are up to ten times more expensive than those operated by the best-performing investigators, as measured by cost-per-data points collected from patients. The Patient Access Score will accelerate patient recruitment and eliminate non-recruiting sites – which is not only critical for sponsors in these economically challenging times, but also lessens the burden on patients.”
Precision in patient-centric trial design
An extension of the existing scoring and performance toolkit that enables precision in patient-centric trial design, PAS provides detailed insights into the number of patients an investigator can potentially reach which the company says goes hand in hand with its lengthy clinical trial experience.
It says this is the first time PAS bridges data between investigator sites and a targeted patient population. This is to make sure the design is optimized to meet commercial objectives and that patient-centricity remains at the heart of development programs.
PAS can measure the probability of an investigator site’s access to the patient population as it has been defined in the protocol.
The patients contributed by investigators from Trial Accelerator, a specific DPP can be constructed. The more cohorts of patients in a DPP, an investigator is associated with, the higher the probability the investigator site will be able to recruit protocol-aligned patients. PAS adds to a set of investigator site performance measures to further enhance the predictability of Trial Accelerator to patient enrollment in clinical trials.
Rare diseases and complex conditions
PAS is applicable in all indications but particularly for rare diseases where few patients are available, as well as non-rare but complex conditions with several comorbidities or a broad range of patient characteristics. For example, despite stroke being the second biggest killer globally, the variation in types of stroke as well as in each patient cohort, makes it difficult to study. Identifying an investigator experienced with the type of stroke under study (i.e., transient ischemic attack, ischemic or hemorrhagic stroke), who also has access to patients in the acute phase of stroke and with the ability to enroll those patients rapidly, is highly challenging.
“I have spent the better part of three decades working on ways to validate sites’ enrollment potential,” explained Beth Harper, President, Clinical Performance Partners, Inc.
“Gen and his team at Phesi have finally cracked the code on how to do this in an evidence-based, efficient, and effective manner. The industry can finally say goodbye to traditional feasibility questionnaires and hello to predictive site performance.”
Phesi’s Trial Accelerator uses real-world, current data, so no inactive investigators or sites are recommended. By generating a specific contextualized score via PAS, sponsors can activate, enroll, and get quality data quickly.