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European Pharmaceutical Contractor

Fit for Purpose

Clinical trials remain the gold standard for establishing safety and efficacy for medical products, but results generated from a carefully structured protocol do not reflect real-world settings and may not be generalisable to scenarios at home and in the clinic. Physicians, their patients, and payers each have a stake in ensuring that results from clinical studies determine the most complete benefit-risk profile possible; as a result, interest in developing real-world evidence (RWE) is on the rise. Increased attention to regulatory applications of RWE is a response to regulatory authorities issuing guidelines for trial designs that include randomised pragmatic trials, as well as studies that employ non-interventional RWE to test effectiveness and safety (1).

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About the authors

Marni Hall, Vice President of Clinical Evidence in the Center of Advanced Evidence Generation at IQVIA, leverages her expertise in regulatory science, drug safety, and patient centricity to provide scientific oversight and strategic direction on the expanded use of RWE. Marni has two decades of experience in both science and policy and has been responsible for developing data standards, sourcing, and analysing datasets, overseeing the delivery of commercial research programmes and the execution of an agenda for use of patient-generated health data in clinical and regulatory decision making.

Nicola Stanislaus PhD, Director of Project Management (Europe) at IQVIA Biotech, is responsible for overseeing study management within IQVIA Biotech’s oncology team. Nicola has more than 15 years’ experience in the conduct and oversight of oncology clinical trials and provides strategic leadership, oversight, training, and ongoing evaluation and support to the clinical operations group.

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