Unbiased Analysis of Today's Healthcare Issues
Clinical trials have detailed study protocols and are registered on ClinicalTrials.gov. What level of details are needed for real-world data (RWD) analyses that aim to estimate treatment effects? In Europe, the European Medicines Agency (EMA) requires registration of many study protocols using a template for observational post-authorization safety studies (PASS) conducted by marketing authorization holders.…
Real-world data is becoming increasingly important as the amount of data generation increases as does the speed of data processing. In the US, the 21st Century Cures Act was enacted in December 2016 and mandated that the Food and Drug Administration (FDA) create a framework for evaluating the use of real-world data help support the…
Clinical trials are the hallmark of the drug development process. In most cases, life sciences firms are required to conduct randomized controlled trials (RCTs) to examine their treatment’s safety and efficacy relative to standard of care. While RCTs do a great job at measuring causal inference, there as a number of limitations. First of all,…
The 21st Century Cures Act, enacted December 2016, mandated that the FDA consider how to use real-world evidence (RWE) to bring innovative treatments to market faster. To meet this statutory requirement, the FDA has provided guidance outlining its policies for using RWE to support the approval of a new drug indication. What is real-world evidence?…
With the FDA’s introduction of new guidelines surrounding the use of real-world evidence (RWE) in medical device regulatory decisions, FDA Commissioner Scott Gottlieb advances the argument for the utility of RWE. In fact, the FDA is currently considering the role of RWE in evaluating pharmaceutical treatments. Despite much debate over what part RWE should play in…