This MAPS podcast discusses common challenges Medical Affairs organizations face in offering best-in-class digital capabilities to its customers.
This MAPS webinar presents an overview of the current and near term Digital Therapeutics landscape and details real-world applications of Digital Therapeutics to illustrate potential in driving transformation of clinical practices to improve patient outcomes.
Part 2 of this series will discuss statistical analysis in clinical trials including null/alternative hypotheses; statistical assumptions (type I error, significance level, type II error, statistical power); hypothesis testing; Statistics used in RCTs, including type of outcome measures, analysis of time-to-event variables (plotting and interpretation of Kaplan-Meier curves).
Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.
Part 1 of this series will: define terminologies in statistics; explain different types of data (quantitative vs. qualitative); describe different ways in presenting summary data (such as proportions, means, medians, range and standard deviation); explain 95% confidence intervals; discuss bivariate analyses and appropriate statistical testing for quantitative and qualitative variables
The medical device industry is facing challenging times ahead. A broader set of influencers (regulators, hospital administrators and other value-orientated customers) will see a shift from individual outcomes to a focus on population-led effectiveness and will require the development of comprehensive value propositions for any device or drug.