What the FDA Guidelines are Recommending
This is the second of a two-part blog inspired by recent recommendations by the Food and Drug Administration (FDA).
The FDA's recommendations, published as guidelines on April 9 in the Federal Register for public comment, are intended to streamline the adverse event reporting process somewhat.
The idea is for adverse events to be reported to IRBs only when they are known to present unanticipated problems for the clinical trial. In other words, they must not have been anticipated when the clinical trial was developed and they must truly present a problem of some consequence to the clinical trial.
The guidelines further recommend that adverse events be reported in context and/or with some analysis that will enable IRBs to determine what implications, if any, the reports have on the continuation of the clinical trial and the safety of the research participants.
Administrative streamlining is generally a good thing, provided a critical step is not missed or information is not omitted. And providing context for data is also generally good.
The problem here arises with the FDA's suggestion that the entity providing reports to the IRBs is the clinical trial sponsor. It is true that if all of the reporting of adverse events that is currently required of investigators to the sponsor is done, then the sponsor is in the best position to identify a particular adverse event as an unanticipated problem. But what if a sponsor chooses not to do so, either intentionally or unintentionally, due to its overriding interest in bringing the product being tested to market?
Companies sponsoring clinical trials of products they own are already under tremendous pressure to see that the trials are finished as quickly as possible, as cheaply as possible and with as few adverse events reported as possible. Asking them to put individually-reported adverse events into context for the IRBs would seem to be asking for trouble.
At a minimum, in addition to submitting reports of adverse events (unanticipated problems) to IRBs, clinical trial sponsors should be required to post all adverse events received from investigators.
This posting could be done easily enough on the World Wide Web, and be made accessible only to those involved in conducting and regulating the clinical trial. The data should remain available for the duration of the clinical trial and throughout the FDA review process. Data would only be taken down if and when the sponsor withdraws its application for FDA approval.
Such open disclosure of all adverse event data would show how the sponsor interpreted the data of which it was aware, perhaps preventing some of the bias (recognized or not) resulting from the sponsor's financial interest.
~Joe
Related Blogs:Related Topics: Technorati Tags: clinical trials, adverse events, FDA, IRBs, health and wellness
The FDA's recommendations, published as guidelines on April 9 in the Federal Register for public comment, are intended to streamline the adverse event reporting process somewhat.
The idea is for adverse events to be reported to IRBs only when they are known to present unanticipated problems for the clinical trial. In other words, they must not have been anticipated when the clinical trial was developed and they must truly present a problem of some consequence to the clinical trial.
The guidelines further recommend that adverse events be reported in context and/or with some analysis that will enable IRBs to determine what implications, if any, the reports have on the continuation of the clinical trial and the safety of the research participants.
Administrative streamlining is generally a good thing, provided a critical step is not missed or information is not omitted. And providing context for data is also generally good.
The problem here arises with the FDA's suggestion that the entity providing reports to the IRBs is the clinical trial sponsor. It is true that if all of the reporting of adverse events that is currently required of investigators to the sponsor is done, then the sponsor is in the best position to identify a particular adverse event as an unanticipated problem. But what if a sponsor chooses not to do so, either intentionally or unintentionally, due to its overriding interest in bringing the product being tested to market?
Companies sponsoring clinical trials of products they own are already under tremendous pressure to see that the trials are finished as quickly as possible, as cheaply as possible and with as few adverse events reported as possible. Asking them to put individually-reported adverse events into context for the IRBs would seem to be asking for trouble.
At a minimum, in addition to submitting reports of adverse events (unanticipated problems) to IRBs, clinical trial sponsors should be required to post all adverse events received from investigators.
This posting could be done easily enough on the World Wide Web, and be made accessible only to those involved in conducting and regulating the clinical trial. The data should remain available for the duration of the clinical trial and throughout the FDA review process. Data would only be taken down if and when the sponsor withdraws its application for FDA approval.
Such open disclosure of all adverse event data would show how the sponsor interpreted the data of which it was aware, perhaps preventing some of the bias (recognized or not) resulting from the sponsor's financial interest.
~Joe
Related Blogs:Related Topics: Technorati Tags: clinical trials, adverse events, FDA, IRBs, health and wellness
1 Comments:
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Nancy
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