THOUGHT LEADERSHIP

The European Parliament and the Council of the European Union approved the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/279) which became enforceable on May 25, 2018.  Because personal information, including health information, is collected during clinical trials, knowing and understanding the GDPR is critical for running clinical trials in the European Union.  Penalties for infringements of specific provisions of the Regulation can reach up to 4% of a company’s total worldwide turnover (i.e., gross revenue).

PROMETRIKA team members make continuous learning a priority. As a statistician, it is important to keep up-to-date with the FDA’s current thinking on analytic approaches applied in clinical trials. In May 2021, the FDA published a draft guidance for industry, “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products,” which provides recommendations for use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to superiority trials and noninferiority trials.  I share some highlights and insights on this topic below.

All team members at PROMETRIKA take responsibility for remaining well versed in the changes in regulations and trends that impact their work. As a biostatistician at PROMETRIKA, I recently attended the American Statistical Association annual Biophamaceutical Section Regulatory-Industry Statistics conference where we discussed the addendum to the E9 (R1) Statistical Principles for Clinical Trials titled “Estimands and Sensitivity Analysis in Clinical Trials.”  The addendum introduces the Estimands Framework and strategies for selecting an estimand. PROMETRIKA invites you to explore this addendum and learn about the estimand strategies put forth in this update. PROMETRIKA can assist you with these and other clinical trial needs.

“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”

“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”