Ensuring patients’ safety must be the most important part of any clinical trial. Second should be ensuring the trial is high quality, reproducible, reliable, and executed according to the trial protocol and statistical analysis plan.
Both of these aims require an insightful and experienced independent data monitoring committee (DMC) to oversee the accumulating unmasked trial data during the course of the trial. Ensuring patient safety includes understanding the clinical and statistical aspects, as well as being able to effectively communicate and interpret the statistical results with DMC clinicians. Ensuring the trial is high quality, reliable, and easily interpretable by regulators, payers, and clinicians requires a statistician with experience in collaborating with all of those stakeholders.
In addition to our founder’s rich experience designing and analyzing trials, working with FDA, and reporting to DMCs, he has served as the voting statistician on many DMCs and currently chairs multiple DMCs. He was also part of the Clinical Trials Transformation Initiative (CTTI) project team that produced formal DMC recommendations in 2016.
Our founder has experience in drug (Phase 1, 2, and 3), device, and comparative effectiveness DMCs ranging from rare diseases to large trials. Please call if you would like to discuss how we may assist in your data monitoring committee.