The traditional process for evaluating new therapeutics may not generate the evidence that patients, clinicians, and payers need to make real-world decisions. The volume and complexity of information ...

This public workshop examined evidence generation for genomic diagnostic test development and explored the evidence needed to determine clinical utility, the study requirements that can help generate ...

We do not conduct studies just to publish; we do so to generate practice‑changing evidence that improves patient outcomes and lives. Yet the journey from study design concept (SDC) to clinical ...

Clinical research in the US needs an overhaul to better optimize health outcomes in a way that matches advances in biomedical science, according to a recent perspective authored by US Food and Drug ...

Real-world evidence (RWE) has become a crucial driver of the pharmaceutical and biotechnology industries in recent years. In fact, RWE is now included in 70 percent of new drug and biologic regulatory ...

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