Real-World Data And Real-World Evidence: What Is Their Value As A Synthetic Control Arm?

By Nach Davé

In times of crisis, there is often value in taking a step back and reassessing some of the traditional ways of doing things. As the clinical research community tackles the issues COVID-19 has raised for ongoing and future studies, we at Premier Research are meeting the challenge of developing alternative paradigms and new ways to solve old problems. One such opportunity that has emerged concerns the use of real-world data (RWD) and real-world evidence (RWE).

As we know, placebo-controlled trials remain the gold standard and will continue to serve as a strong pillar of how therapies are evaluated. However, it is commonly accepted that a single-arm trial utilizing a synthetic control arm (SCA) can also be an adequate design for assessing a new treatment intervention. Single-arm trials demonstrate clinical benefit by showing the positive effects of a new therapy or treatment without the need to use placebo or standard of care as a control. Instead, RWD and RWE comparisons – leveraging a variety of sources – can serve as the comparator.