Description of clinical study: Non-Interventional Study for Analysis of Molecular Diagnostics and Treatment Patterns in Metastatic Non-Small Cell Lung Cancer Patients (Newly Diagnosed and Relapses from Earlier Stages)

Sqilline has partnered with a leading pharmaceutical company to conduct a Non-interventional Study analyzing Molecular Diagnostics and Treatment Patterns in Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients, encompassing both newly diagnosed cases and patients experiencing relapses from earlier stages.

CHALLENGES:

• Real-world Data Analysis Complexity: Analyzing treatment and biomarker testing patterns for newly diagnosed and relapsed metastatic NSCLC patients entails navigating the complexity of diverse patient cases and treatment histories.
• Data Collection from EMRs: Retrieving comprehensive and accurate data from Electronic Medical Records (EMRs) poses challenges in ensuring data completeness and reliability.
• Anonymity and Consistency: Maintaining anonymity, consistency, and homogeneity in data collection via a web-based e-CRF presents essential challenges for preserving data integrity and adhering to privacy regulations.
• Future Data Extraction: Planning for future data extraction points for retrospective secondary analysis requires careful coordination and documentation to ensure continued data availability and usability for ongoing research.

STUDY INPUT PARAMETERS:

• Countries: Bulgaria, Greece
• Number of Sites: 5
• Total number of patients processed by AI algorithm: 233,985

RESULTS:

• Total number of eligible patients identified through the AI algorithm: 510
  • 126 with EGFR tumor mutation
  • 384 with PDL-1 expression
• Total number of patients successfully enrolled in the clinical trial: 250
  • 120 patients with EGFR tumor mutation
  • 130 with PDL-1 expression

BENEFITS FOR INVESTIGATORS AND SPONSORS

• Enhanced Efficiency
• Accelerated Patient Enrolment
• Fast integration of Danny Platform with the sponsor’s eCRF ensures seamless data exchange, expediting the trial management process and enhancing overall study efficiency

WHY DANNY eCLINICAL RESEARCH

Danny eClinical Research offers advanced technology, streamlined processes, rapid patient enrollment, and seamless integration, making it a valuable partner for sponsors and investigators seeking to optimize their clinical research.

• 70% decrease in the start-up cycle for the NIS Study
• 55% reduction in investigator time
• 5 times faster patient enrolment process for the sponsor