THOUGHT LEADERSHIP

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 In May 2021, the FDA published a draft guidance for industry, “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products,” which provides recommendations for use of covariates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.

Drug development and clinical research methods evolve continuously through establishment of new regulations and through adaptations to changes in treatment accessibility, technology, evolving knowledge in biology, and appearance of new diseases. 

Patient-centric trials, in which the perspective of the patient is considered in study design and performance, is one such new approach in clinical research that primarily focuses on reducing patient burden. 

In 2021, FDA has so far approved six antibodies against PD-1 or PD ligand 1 (PD-L1) for more than 75 indications. Ipilimumab remains the only FDA approved anti-CTLA-4 antibody, in melanoma indications and, in combination with nivolumab (an anti-PD‑1 antibody), in a number of other indications.

Basic research in the 1990’s showed that antibodies aimed at a cell surface marker called cytotoxic T-lymphocyte antigen 4 (CTLA-4) stimulated an immune response that resulted in the killing of the tumor cells. Another cell marker, programmed death-1 (PD-1), was found to have the ability to prevent the immune system from killing cancer cells. These discoveries led to the development of cancer therapy using inhibition of negative immune regulation.