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# Califf Wants ‘Sweeping Overhaul’ of Clinical Trial System
- URL: https://www.fdaweb.com/califf-wants-sweeping-overhaul-of-clinical-trial-system/
- Published: 2017-08-15T12:00:00.000Z
- Updated: 2026-09-14T22:41:24.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5139386

Former FDA commissioner **Robert Califf** says a sweeping overhaul of the current clinical trial system is needed and underway. [Writing](http://www.fdaweb.com/download.php?file=califf8-2017.pdf) in the *Journal of the American Medical Association*, Califf acknowledges complaints that the current system moves too slowly to approve new drugs or rushes new drugs to market without adequate testing, as outlined in two other articles in the journal, one relating to drugs and one to medical devices. “In general, the current approach is acclaimed by those with the most at stake — patients and their families,” Califf writes. “At the same time, the articles … raise issues that merit deeper study and discussion within FDA and in the clinical and payer ecosystems affected by the agency’s standards.”

According to the article, substantial progress in balancing safety with access to effective therapies will come from systemic changes in the ecosystem rather than incremental modifications made by imposing more severe demands on individual products. “As electronic records, information storage, and analytic methods continue to improve,” Califf writes, “there are no technical limitations that would prevent tracking a marketed drug or device throughout its life cycle.”

He calls for creation of a federated (rather than fully centralized) national system that generates fundamental information such as identification of drug dispensing and device identifiers and that measures clinical outcomes continuously. “These data should be linked to practices within organized health systems to enable use for multiple purposes, including conducting observational studies and pragmatic trials,” Califf says. “Because the same information can be used and reused for different purposes, the data quality should improve and costs should decline over time as data are curated and prospective research systems are reused. Ongoing evaluation of these new systems will be needed to ensure they are as effective as hoped.”