Drugs

Fix the Evidence Generation System Now: Califf

FDA commissioner Robert Califf says a major reformation of our national system for generating medical evidence — the clinical research enterprise — is needed to facilitate the translation of biomedical research into useful products and interventions. Writing in the journal Clinical Trials, Califf says that currently premarket systems for generating and evaluating evidence work reasonably well, but the postmarket phase “is disaggregated and often fails to answer essential questions that must be addressed to provide optimal clinical care and public health interventions for all Americans.”

He notes that despite significant advances in biomedical science, corresponding improvements in health outcomes lag significantly. That situation is particularly true in the U.S., he writes, where life expectancy trails far behind that of other high-income countries. “In addition,” Califf says, “substantial disparities in life expectancy and other health outcomes exist as a function of race, ethnicity, wealth, education, and geographic location.”

The article says that solving these problems will require a focus on:

improving the integration of and access to high-quality data from traditional clinical trials, electronic health records, and personal devices and wearable sensors;
restructuring clinical research operations to support and incentivize the involvement of patients and frontline clinicians; and
articulating ethical constructs that enable responsible data sharing to support improved implementation.

Califf says the nation must also address the systemic tendency to optimize individual components of the clinical research enterprise without considering the effects on the system as a whole. “Overcoming suboptimization by creating incentives for integration and sharing will be essential to achieve more timely and equitable improvement in health outcomes,” he writes.

FDA has a critical role to play in reshaping the systems for evidence generation and dissemination, Califf asserts. He says the agency’s unique position as a regulatory, scientific, and public health agency gives it both insight and clout.

“The majority of clinical research funding comes from the medical products industry,” Califf writes, “and FDA regulations and guidance provide a framework for the creation of scientific evidence that helps us better understand the balance of benefits and risks of medical products when used in practice. However, holistic solutions to broader issues currently impeding evidence generation will require collaboration across many sectors, together with creative and collaborative approaches to overcome financial disincentives that hinder commonsense improvements.”

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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