News/Commentary

This full free text article from The New England Journal of Medicine, by Ethan Basch, M.D., explains that clinicians’ assess patients’ responses in clinical trials.

Nobody’s asking the patients what they think they are feeling or experiencing.

This article says that getting information from patients could add valuable information. “Self-reports are more sensitive to underlying changes in patients’ functional status than are clinicians’ reports and tend to identify symptoms earlier in the course of treatment.”

The point of a clinical trial is to ask and answer questions about how well the drug works and how well patients tolerate it.

This is an important topic, one almost never discussed.

Please do read the article. The next time you read the tiny type on your drugstore print-out, you will know who reported these adverse reactions.

It was not patients.

That should change.

The New England Journal of Medicine

“A patient wants to know about symptoms she may have from a prescription drug she is taking. Consulting the label’s “Adverse Reactions” section, she finds a wealth of data. Little does she realize that this information, largely collected during clinical trials, is based almost entirely on clinicians’ impressions of patients’ symptoms — not on patients’ own firsthand reports of their experiences with the drug. (Emphasis added)

“The current drug-labeling practice for adverse events is based on the implicit assumption that an accurate portrait of patients’ subjective experiences can be provided by clinicians’ documentation alone. Yet a substantial body of evidence contradicts this assumption, showing that clinicians systematically downgrade the severity of patients’ symptoms, that patients’ self-reports frequently capture side effects that clinicians miss, and that clinicians’ failure to note these symptoms results in the occurrence of preventable adverse events.(Emphasis added)

“The prospective collection of data directly from patients about symptoms they have while taking a drug (so-called adverse symptom events) is an alternative approach that could add valuable information to current practice. Self-reports are more sensitive to underlying changes in patients’ functional status than are clinicians’ reports and tend to identify symptoms earlier during a course of treatment. Current methods for detecting adverse events in clinical trials are acknowledged to lack sensitivity, and worrisome symptoms might well come to light earlier in the drug-development cycle if reporting by patients were standard practice.” (Emphasis added/Footnotes deleted)

Citation: New England Journal of Medicine, Online, March 10th, 2010