The evolution of industry-sponsored patient registries

Public Release: 29-JAN-2018


This article by Dr. Jeff Trotter and Dr. Grannum R. Sant is published in Applied Clinical Research, Clinical Trials and Regulatory Affairs, Volume 4, Issue 3, 2017

Patient Registries have become increasingly critical as a mechanism for life-sciences companies to better understand treatment outcomes and the clinical, economic, and humanistic value of innovative drugs and devices in actual practice settings. This edition's Editor's Choice is the brief but insightful Commentary: The Evolution of Industry-sponsored Patient Registries' by Grannum Sant and Jeff Trotter, both of whom having considerable experience in this unique subject matter. The commentary presents valuable perspectives on why registries represent a vital research tool for generating "real world" data of particular interest to payers, physicians, patients and, even more so today, regulatory agencies and policymakers. The article provides useful insight on the critical design and operational differences between registries and more traditional controlled research initiatives, while objectively shedding light on the advantages and limitations of both approaches.

"Registries will not replace RCTs as a primary vehicle for understanding the efficacy of a drug and, hence, as the basis for regulatory approval," stated Jeff Trotter, President of Continuum Clinical, "The value of procedural controls in isolating the effect of a drug cannot be replicated in a registry. However, RCTs provide only limited value in medical decision-making since the approved products are used in settings in which we can't control for patient variability, concomitant conditions, and so many other elements that must be taken into account. We see registries as complementing traditional clinical trials, but also as a primary vehicle for generating evidence of real-world value for critical stakeholders."

This important commentary provides insights into the past and future of registries and the critical and unique role that the life-sciences industry can play in supporting the proliferation of these objective research programs, particularly within the context of the importance of accommodating patient perspectives through advanced technology.

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