Global contract research organization (CRO) PPD has collaborated with clinical technology firm Clinical Ink to develop a systemic lupus erythematosus (SLE) assessment review process that is intended to simplify the operation of clinical trials for the autoimmune disease. According to the companies, the collaborative approach is focused in enhancing data quality, as well as improving site staff experiences and inefficiencies, to help develop novel SLE therapies.
Carol Olson, senior vice president and head of global product development with PPD, told Outsourcing-Pharma that trials involving SLE can be especially complex, particularly regarding assessments and endpoints.
“In a landscape that currently has high competition for sites and patients, focusing on reducing burden and mitigating operational complexities is key,” she told us. “PPD’s SLE assessment review process, which includes Clinical Ink’s eLAS system, removes transcription requirements and reduces patient visit time."
Olsen added that combining the technology and expertise of the two companies has led to the ability to reduce the number of vendors required for SLE trials, with some trials having more than 10 separate vendors: “All of these improvements combine to achieve the goal of reducing site and patient burden while ensuring data quality and consistency is maintained,” she said.
The partnership also, Olson commented, helps reduce patient burden, an important consideration when dealing with participants that suffer from SLE.
“One area of burden we hear from patients is the challenge presented by long study visits; that’s a consideration for many patients, but given that SLE patients are already immune-compromised, the concerns with long visit times understandably increases, and even more so during the time of this global pandemic,” she said. “By utilizing eLAS, the time for physical exam and data collection for both eCOAs and ePROs is considerably reduced; the assessments are completed all on one device, which also improves the efficiency of collecting data during the visit.”
What’s more, Olson commented, the technology can help simplify and streamline the workload for trial teams.
“SLE trials are operationally complex, particularly when it comes to SLE assessments and endpoints; in a landscape that currently has high competition for sites and patients, focusing on reducing burden and mitigating operational complexities is key,” she explained. “All of these improvements combine to achieve the goal of reducing site and patient burden while ensuring data quality and consistency is maintained.”
Clinical Ink president Doug Pierce said the combined technologies offer hope for SLE-focused researchers, sponsors, and patients.
“By bringing together this custom version of eLAS with PPD’s dedicated expert review team, we are combining efforts to deliver new and enhanced capabilities for customers who are developing new SLE treatment options,” Pierce said.
Clinical Ink’s eLAS is a therapeutic-specific application of its Lunexis platform, which includes an integrated suite of SLE disease assessment questionnaires and patient-reported outcomes completed by clinicians and patients. Investigators enter patient data once, then the system automatically populates the appropriate fields across the required assessments, reportedly reducing redundant data entries and errors to save time and increase site efficiencies.