FDA looks for more access to electronic data to assess safety

A new report from the U.S. Food and Drug Administration calls the verification of the accuracy of electronic patient data crucial in evaluating drug safety.

Following the approval of a drug, the real-world patient population that uses that drug rarely is the same as the population evaluated in clinical trials, according to the report. Larger or more diverse postmarket randomized clinical trials could offer an unbiased approach to identifying risks and benefits, but aren't always feasible.

Therefore, other postmarket data sources--such as electronic medical records data, hospital discharge data, and prescribing data--should be considered. However, since the content and quality standards associated with postmarket data sources are established for purposes other than safety analysis (e.g., reimbursement, clinical care), the sources should be "assessed for their strengths and weaknesses for use in regulatory decisions," the report says.

The validity of "exposure and outcome information, as identified in electronic healthcare data, needs to be evaluated for its use in regulatory assessments," as well, says the report released this week by the FDA's Center for Drug Evaluation and Research.

This includes, for example, "assessing systematically" the accuracy of ICD diagnostic codes, which commonly are used in administrative claims data to identify patients with clinical adverse events.

In addition, the use of "validated algorithms" for determining various safety outcomes could be used "to better inform drug safety studies conducted by government, industry, and academia," according to the report.

The FDA has opened a 60-day comment period on the report.

For more information:
- view the FDA report
- see this post from The Hill's Healthwatch blog

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