Collecting Real-World Patient Drug Experience

www.clinipace.com to the chilling effect such warnings can have on healthcare providers. To say that negative real-world outcomes destroy shareholder value for the manufacturer would be obvious, but it can also be detrimental to legions of patients as well. Prospective drug scrutiny should not stop once a drug is approved, and more than ever, it is critically important to consider the role of post-marketing surveillance in the life-cycle management of a product, and such a To say that negative realworld outcomes destroy shareholder value for the manufacturer would be obvious, but it can also be detrimental to legions of patients as well. plan should be in place well before its introduction into the market. Where to Start? With an Observational Approach While there are several methodologies for monitoring a marketed drug, an observational model can provide a powerful platform for collecting real-world patient experience with a drug or medical device. Various forms of observational studies include patient/disease/drug registries and epidemiological studies. It is “observational” in that patient is treated as the physician would treat any patient – and not on a strict visit schedule, and without regimented drug treatment [it is up to the physician] so the patient is observed in a real-world practice setting. In contrast to hypothesis-driven phase IV studies with a defined protocol, observational studies are generally not protocol-driven and have several other core differences. Page | 2 ©2008 Clinipace, Inc. All rights reserved.

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