Beyond Regulatory and HTA Success: Reaching Physicians and Patients
We statisticians play a significant role in the clinical development of pharmaceutical products and medical devices. Many of us focus on designing and analyzing clinical trials to provide evidence for regulatory approval and Health Technology Assessment (HTA). In these set-up, we often talk rather directly to our external clients – regulators and payers (at least the big ones). This looks very different in medical affairs. Just for the sheer number of clients (and other reasons) we statisticians rarely get the chance to communicate directly with physicians, caregivers, and patients. And we need to convince these as this is really the last hurdle …
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