Benefit Risk Assessment: CV Example
Issue: A pharmaceutical client approached DMS to create a benefit risk assessment of their target product relative to current treatment modalities in the marketplace for patients with atherothrombotic disease. Solution: We constructed a benefit risk assessment (BRA) based on a thorough review of the clinical trial data for the target product as well as results […]
Predictive Analytics: Worsening Renal Function Example
Issue: A major pharmaceutical client sought to better understand whether select renal biomarkers associated with acute heart failure (AHF) were predictive of patient outcomes (readmission risk, mortality risk, lengthy length of stay and high costs). Solution: We identified and characterized distinct patient phenotypes that had either persistent worsening renal function (WRFp) or transient worsening renal […]
Predictive Analytics: Biomarker Example
Issue: A major pharmaceutical client sought to better understand which biomarkers associated with acute heart failure (AHF) were predictive of patient outcomes (readmission risk, mortality risk, lengthy length of stay and high costs). Solution: We conducted a novel two stage GLM and logistic regression modeling analysis using baseline patient and hospital characteristics to determine which […]
Multi-Country Retrospective Database Analyses: Oncology Example
Issue: A major pharmaceutical client sought to better understand patient demographics, clinical characteristics, treatment trajectories, healthcare resource use, costs and survival outcomes among patients with esophageal and gastric cancers in China, South Korea, Taiwan, Japan, and the U.S. Solution: We conducted a five-country study using a standard study protocol with specific country modifications simultaneously. This […]
Multi-Country Chart Abstraction Study: Oncology Example
Issue: A major pharmaceutical client sought to better understand patient clinical characteristics, treatment trajectories and treatment outcomes among patients with relapsed and refractory multiple myeloma (RRMM) across Turkey, Russia and Brazil. Solution: We conducted a physician-led disseminated chart abstraction study in the target countries. Data was collected using a standard electronic chart abstraction form (eCAF) […]
Synthetic Data/Matching: Oncology Example
Issue: A major pharmaceutical client sought to leverage data from a single arm, US-based study on oncology to compare with results published ex-US where the ex-US patient-level data was not available Solution: DMS extracted from the published ex-US data the key descriptive statistics information that was available. Synthetic data sets replicating this information were developed […]