• Methods for addressing missing data in longitudinal studies have been written about extensively for many years, but the focus has increased more in the past decade with the publication of the EMA Guideline on Missing Data in Confirmatory Clinical Trials and the National Research Council’s treatise on The Prevention and Treatment of Missing Data in Clinical Trials both in 2010 and the release of ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials in 2017.  Case studies and new methodologies addressing the handling of missing data are published on a regular basis.  Yet for all the attention this topic receives, and perhaps because of the abundance of information on this topic, clinical researchers often do not know what data imputation approach is best for their particular clinical trial. 

  • Since its founding in 2003, PROMETRIKA has provided paid internship positions to about 30 young women and men in a variety of disciplines, either directly or through relationships with colleges and universities. Historically our interns have been mostly from Massachusetts institutions including Boston University, Wentworth Institute of Technology, Harvard University, Smith College, UMass Lowell, and Emerson College. While a majority of our interns have been graduate students working toward their Master’s or doctorate in biostatistics and other public health disciplines, we have recently expanded our program to include undergraduate students in a variety of disciplines such as biological sciences, mathematics, and computer science. 

  • The development of the Package Insert (PI), also known as the Product Information, Prescribing/Prescriber’s Information, or simply “the Label,” is a long, complex process typically managed by a regulatory professional. It is a collaborative document, incorporating contributions from chemistry, toxicology, medical/clinical, biostatistical, writing, and regulatory professionals. Drawing from experience on a recent project, I would like to focus this installment of Protocol to Package Insert on the derivation of the clinical safety data that appear in the PI.

  • AICROS, the Association of International Clinical Research Organizations, is a consortium of small to mid-size CROs that collaborate to provide clinical research services to the biotechnology, pharmaceutical and device industries worldwide. PROMETRIKA joined AICROS in 2018 and on May 29 -30th, PROMETRIKA’s Head of Clinical Operations, Heather Paden, attended the AICROS Annual meeting, which took place in Kaunas, Lithuania.