Data sourcing can be challenging. Identifying optimal data sources requires extensive insight into the data landscape relative to specific research needs. Successful data sourcing will require a balancing act between research priorities and data availability.
Choosing the right data to answer research questions is important, especially when it comes to developing an external control arm. External comparators or controls (also known as historical controls) have the potential to improve the evaluation of novel experimental agents in clinical trials.
In 2016, the 21st Century Cures Act (Cures Act) directed the Food and Drug Administration (FDA) to accept statistical methods that include Real-World Data (RWD) and Real-World Evidence (RWE). The next year, the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued guidance regarding the submission of RWD and RWE to the FDA.