The Power of Real-World Data to Support Clinical Development
Randomized controlled trials (RCTs) are the accepted gold standard for medical product clinical development programs, however, there are times where RCTs are not feasible or ethical. In those circumstances, external control arms (ECAs) may be the right solution to augment trial data.
Advances such as gene and mRNA therapies, and the increasing focus on rare disease and new cancer indication treatments have led to trials in indications for which there is a high unmet medical need and corresponding questions about the suitability of traditional RCTs. In these cases, a single-arm study becomes necessary, and ECAs become an important and viable option to generate comparator data.