TL12 - Estimand Framework as a Tool for Biometrics Quality Assurance and Quality Control and as an Opportunity for Biometrics Leadership

The estimand framework enables trialists define causal effects in clinical trials in the presence of estimation challenges, including protocol deviation, noncompliance, and missing data. The benefits of the estimand framework have been emphasized in enabling trialists in defining a clear, precise causal question and identifying a strategy for answering the question in the presence of these challenges. However, estimand framework has been underemphasized in terms of its benefits in facilitating biometrics quality assurance and quality control. Additionally, some aspects of good biometrics leadership entail developing people and supporting them as they scale their activities and avoid learned helplessness, but estimand framework has been underemphasized in terms of it providing an opportunity for biometrics leadership. Therefore, this session will address the following questions:
1) What role does the estimand framework play in quality assurance and quality control?
2) How does the estimand framework affect response to questions during regulatory inspection?
3) Which biometrics standard operating procedure will likely retire as sponsors adopt the estimand framework?
4) How does the estimand framework serve as an opportunity for biometric leadership?
The session will be particularly beneficial for participants interested in learning about compliant, robust, lean, fit-for-purpose effective biometrics strategies.

estimand

quality Assurance

quality control

leadership 

Clinical Trial Design (e.g., Innovative/Complex Design, Estimands, Master Protocol)

ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2023