THOUGHT LEADERSHIP

PROMETRIKA’s portfolio of services includes extensive work in New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs). In the company’s 16 year history, PROMETRIKA team members have collaborated on 19 NDAs and MAAs. Our data managers, statistical programmers, biostatisticians, and medical writers have designed, implemented, and reported on the clinical submission data in indications such as oncology, CNS/psychiatry, renal disease, respiratory disease/allergy, and several rare diseases. PROMETRIKA’s NDA/MAA Project Managers (PMs) have developed the tools and skills necessary to successfully manage the study level team and the subject matter experts to complete submission projects with high-quality, on-time deliverables.

Hwang et al.[i] completed a study looking at 640 phase 3 trials investigating novel therapies and found that 54% of these projects failed in clinical development; 57% of the failures were due to inadequate drug efficacy.  This means that 43% of the projects that failed were due to reasons other than the efficacy of the drug.  It is likely that many of these failures were due to operational deficiencies.  It is important to consider that a Sponsor’s investment in a trial is not only the investment made for the phase in which the project fails, but all investments from discovery leading up to the failure.

In recent years, efforts to streamline clinical research activities while improving subject safety and data integrity have included risk based monitoring (RBM). As recently as May 2019, the International Council for Harmonisation (ICH) proposed revisions to its General Considerations for Clinical Studies (E8) guideline. Section 3 of E8 (R1) stresses the importance of managing the quality of safety measures and data collection as part of an entire Quality Plan in a clinical program and its studies. This effort is called Risk-Based Quality Management (RBQM).

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.