by Scott Brown, PhD | Oct 11, 2022 | Data Management
The notion of statistical error permeates clinical study design and analysis, forming the basis for regulatory decision-making in evidence-based medicine, where the vaunted p-value is a cornerstone of analysis. In addition, statistical error is a key factor in sample...
by Scott Brown, PhD | Jun 14, 2022 | Study Execution
When bias creeps into a clinical study, the result can be a dubious reception by regulators and the scientific community. The solution is careful study design to minimize bias. In this blog post – a continuation of our series on common pitfalls in clinical study...
by Scott Brown, PhD | Mar 8, 2022 | ClinReg Strategy
The randomized controlled trial (RCT) is the gold standard of clinical research, providing the highest level of scientific data for evidence-based medicine, and is often referred to as “Level I” in literature reviews and meta-analyses. RCTs are usually the most...
by Scott Brown, PhD | Sep 14, 2021 | Study Execution
Every medical device clinical study has endpoints, although they may be called something else, such as outcomes or metrics. Regardless of the name, we are talking about the objective, measurable results of a clinical study that are used to evaluate safety,...
by Scott Brown, PhD | Jul 13, 2021 | Study Execution
When designing a medical device clinical study, if you don’t begin with the end in mind, you’re likely to encounter costly surprises during the study or in the subsequent regulatory application process. With patient safety, product success, and business objectives...
