The evolution of RWE to support regulatory approval for new treatments and label expansions
With RWE gaining traction with regulators, both nonrandomized real-world studies and randomized pragmatic clinical trials are contributing to regulatory assessment and decisions concerning new or expanded treatment labels.
Regulators have gradually demonstrated adoption of RWE alongside clinical trial data, finding it beneficial during the evaluation process of new or expanded product indications in selected situations. Today, when life sciences companies include RWE as a complement to their new or expanded product submissions, they are well positioned to address questions about the safety or effectiveness of treatment, particularly for subgroups and situations of special interest.
