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# JAMA Article Raises Doubt on Replicating Trials
- URL: https://www.fdaweb.com/jama-article-raises-doubt-on-replicating-trials/
- Published: 2019-10-11T12:00:00.000Z
- Updated: 2026-09-15T01:55:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145233

A [new study](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2752575?utm%5Fsource=twitter&utm%5Fcampaign=content-shareicons&utm%5Fcontent=article%5Fengagement&utm%5Fmedium=social&utm%5Fterm=101019#.XZ8KHWuaZbk.twitter) in *JAMA s*uggests there is limited feasibility for the the idea of replicating clinical trials using real-world evidence (RWE). Researchers from numerous academic centers and industry examined clinical trials with human participants that were published in high-impact journals in 2017 and found “only 15% of the trials could have been feasibly pursued using currently available real-world data from structured EHR \[electronic health records\] and insurance claims.” 

The findings, the authors write, “reinforce the caution about the promise of RWE replacing RCTs \[randomized clinical trials\]. Using observational methods and data sources is not feasible for examining the safety and efficacy of a medical product that is not in widespread use in routine clinical practice. This study also raises a second caution about the promise of RWE augmenting RCTs. Many of the trials could not be replicated because they would require data that are unlikely to appear in an EHR in structured form if at all. Several improvements in the collection and analysis of EHR data may enhance the use of real-world data to generate RWE, including increased use of patient-reported outcomes as part of routine clinical care, more widespread use of medical device surveillance initiatives, and improvements in natural language processing for free text in EHRs.”

Notwithstanding the limited feasibility of replicating trials using RWE, the authors do see great promise in RWE, such as its use to generate postapproval evidence of medical product safety and efficacy for drugs with limited evidence to support their use. “Similarly, producing sufficient evidence to support an FDA action to communicate a safety concern to patients and clinicians can take more than four years,” they explain. “Real-world evidence can be used to more rapidly generate actionable safety evidence, which is rarely pursued through clinical trials. Furthermore, RWE may be particularly useful because prospective postapproval studies can be difficult to recruit for given that patients can receive the therapy outside the trial, as occurred with the off-label use of atrial septal closure devices.”