Drugs

FDA Working on Evidence Generation System

FDA commissioner Robert Califf and associate deputy commissioner for medical products and tobacco Rachel Sherman say that FDA is involved in developing a national system for evidence generation that can improve the ways in which scientific evidence to support medical product evaluation and clinical care decisions is generated. Writing in the first of several FDA Voice blog posts on the topic, the two look at the foundational concepts of interoperability and connectivity.

The post defines interoperability as the idea that different systems used by different groups of people can be used for a common purpose because the systems share standards and approaches.

“Patients, consumers, professional groups, payers, the medical products industry, and health systems all stand to benefit from potential gains in efficiency and reductions in cost that would accompany standardized approaches to data collection, curation, and sharing, once up-front investments are absorbed,” they write. “Then, with these standards in place, effort could be devoted to generating actionable knowledge rather than simply managing data.”

Califf and Sherman also call for creation of an interconnected environment that leverages all the available data to provide answers to important public health questions. “A defining characteristic of such a network,” they say, “is the ability to leverage all available data for different tasks as needed, allowing the network to integrate complex relationships between data input and output. Coupled with interoperable standards, a national system for evidence generation based on these principles will be capable of generating very large quantities of data and enabling those data to flow among system components.”

The post concludes that interoperability and connectivity represent the “scaffolding” that must be developed and put in place to support a national system for evidence generation.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome