DURHAM, N.C., SEPTEMBER 29, 2016 — Point-in-time “landmark” analysis, the standard in most chronic pain studies, may not be appropriate for evaluating single-dose drugs. Instead, an analysis strategy similar to that used in acute-pain research may be more effective, Premier Research’s top biostatistics expert will assert in a poster presentation at the American Statistical Association’s 2016 Regulatory-Industry Statistics Workshop.
Jennifer Nezzer, Director of Biostatistics, will present A Comparison of Primary Analyses for Chronic Pain Data on Friday, Sept. 30, at the ASA biopharmaceutical meeting in Washington, D.C. The presentation begins at 9:45 a.m.
While these drugs are not taken on a regular basis, they may be re-dosed as needed if pain returns, making them effectively similar to acute-pain treatments. Nezzer will explore the operating characteristics of MMRM (mixed-effect model repeated measure) analysis versus cumulative-relief analysis under various conditions that might simulate potential drug effects over time.
The 45-minute discussion also will consider the impact of missing data, overall effect size, and timing of maximal treatment effect.
About Premier Research
Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical device, neuroscience, oncology, pediatric, and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.