Clinical Trials

Case Study: Clinical Trial Support
For a GI compound in development, we developed the statistical section of the study protocol, helped develop an electronic patient data collection system, designed the case report form, wrote and implemented the statistical analysis plan, assisted with the CSR development, and provided regulatory support throughout the entire process.  

With broad therapeutic experience across all phases of clinical development, we can provide a complete set of statistical services for clinical trials, including:

  • Protocol and statistical analysis plan (SAP) development
  • Sample size calculations
  • Randomization
  • Interim and final data analyses
  • Clinical Study Reports (CSR)
  • Support for regulatory agency submissions

In addition, our statisticians are well versed in outcomes research methods and will work with you to plan and analyze your clinical outcome assessments to help achieve your product development and market access objectives.

QoL Analyses

Patient-centered outcomes and other quality of life (QoL) assessments may be used to demonstrate additional benefits to patients and provide compelling evidence for product registration. We have experience with multiple scales, scoring algorithms, and application of analytical techniques to account for the nuances of QoL, including examination of missing data. Our team of statisticians is well-versed in the analytic techniques needed to calculate health-state utilities, including mapping to EQ-5D. 

Q-TWiST Analyses 

Q-TWiST (quality-adjusted time without symptoms or toxicity) is an approach that can help patients evaluate the trade-off between clinical benefit and treatment toxicity to make informed treatment decisions based on the relative importance they place on different health outcomes. Even if patient-reported QoL data was not collected in your study, we can apply the Q-TWiST method to quantitatively assess the benefit/risk tradeoff of your new treatment regimen.

Healthcare Resource Utilization

Our team of biostatisticians and health economists can analyze the healthcare resource utilization data from your clinical trials. We apply unit costing to clinical trial data and provide analysis of non-normal cost and resource utilization data to demonstrate the cost and healthcare benefits of your new treatment.

Exploratory Data Analysis

In addition to protocol-specified analyses, we provide a wide variety of exploratory data analysis services to extend the utility of your trial data. Our experience includes:

  • Subgroup analysis
  • Identifying patterns of treatment response
  • Analysis of pooled data from multiple studies
  • Associations between clinical and patient-centered outcomes
  • Assessing burden of disease
  • Exploring the impact of missing data 

We will collaborate with you to design and conduct exploratory analyses, report the results to stakeholders, and prepare conference presentations and manuscripts for peer-reviewed journals