To gain approval for a new drug or a new use of an existing one, drugmakers are shifting away from conducting traditional clinical trials and instead determining the efficiency of a drug by analyzing data sets from electronic medical records, according to The Wall Street Journal.
Clinical trials are often expensive and can take years. By looking at data from electronic medical records, drugmakers can see how a drug performs in a matter of months and avoid costly clinical trials.
Pfizer, Johnson & Johnson and Amgen have used health record analyses when seeking FDA approval for a new drug or for a new use of an existing drug, according to the Journal. The FDA has approved new uses for breast cancer, bladder cancer and leukemia drugs based on health record data.
Drugmakers mine hospital and physician files, looking at data for patients who are already taking an approved drug to look for changes in blood pressure, tumor size or other factors to see if the drug is helping them or causing a side effect. Using this data can help avoid costly, time-consuming clinical trials.
But some physicians say that health records often have errors that could skew results, and that error-free records still may not produce results of the same quality that a clinical trial would.
Supporters of health record analyses say they wouldn't completely replace clinical trials. The records would augment trials or be used instead of trials for new uses of existing drugs.
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