Biostatistics

Clinical Design

Special approaches like Adaptive Design

• Pre-Defined Statistical Approach: Our team ensures statistical methods are pre-defined in the protocol to maintain integrity and consistency
• Statistical Complexities: Adaptive designs introduce challenges such as balancing adaptation with statistical validity, managing variability, and avoiding biases. These complexities are managed by experts
• Multiplicity and Alpha Error: Multiple interim analyses can affect the overall alpha error rate. We make necessary adjustments to control type I error and ensure valid results

Sample Size Calculations

Key Considerations for Sample Size Calculation:

• Study Design Factors: Assessing all relevant aspects of the study to ensure comprehensive analysis
• Patient Burden Reduction: Minimizing patient burden to achieve significant cost savings while maintaining the required statistical power and regulatory compliance
• Balancing Risks and Costs: Finding the right balance between the risk of trial failure, costs, and recruitment time to streamline the trial process
• Expert Analysis: Leveraging the expertise of COD specialists who evaluate impacting factors, complexities, bio-statistical nuances, and associated risks in proposed statistical possibilities