Report: Ignoring past trial data is unethical

Johns Hopkins researchers are in agreement with those helping the FDA on the missing trial-data challenge: The regulator does have a very large database of clinical trials as yet untapped for insights that may improve new trials (see related story). But the Johns Hopkins team says it with oomph. "Failure to consider existing evidence is both unscientific and unethical."

In some cases, patients who volunteer for clinical trials may be getting a placebo for a medication that a previous researcher has already determined works or may be getting a treatment that another researcher has shown is of no value. In rare instances, patients have suffered severe side effects and even died in studies because researchers were not aware of previous studies documenting a treatment's dangers.

Clinical trials can't be interpreted without a full accounting of the existing evidence, says Karen Robinson, co-author of the research with Steven Goodman.

They find that researchers on average cite less than 21 percent of previously published, relevant studies in their papers. And for research with at least five prior publications available for citation, one-quarter cited only one previous trial, while another quarter cited none. Studying prior research, they say, can lead to study designs that are more likely to fill gaps in the evidence.

- see the Johns Hopkins release

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