We are all trying to learn as much about prostate cancer as we can. The FDA Revitalization Act will make a difference once it is implemented. Patients deserve to know both positive and negative outcomes from trials. Patients need to speak out and make sure that this happens and that trials are registered and all results are reported.
The FDA Revitalization Act sets a precedent in mandating the reporting of trial results in a public database. The table format it mandates — comprising information on trial participants and primary and principal secondary outcomes — is a reasonable approach to results reporting. In the upcoming rulemaking, the secretary of Health and Human Services should consider this format for the reporting of serious adverse events. The format confines itself to simple facts, intentionally omitting any place for interpretation of the trial’s results. It encourages sponsors to prespecify and to register their key secondary outcomes, because those would then become part of the results database.
To read the entire opinion piece in the New England Journal of Medicine click here.
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