FDA's New Adverse Event Guidelines
Last month, the Food and Drug Administration (FDA) published a set of what it calls non-binding recommendations concerning when and how adverse events are reported.
In the world of clinical research the term "adverse events" refers to things that go wrong during a clinical trial. An adverse event may be caused by the drug or device being studied. It may be caused by the clinical trial itself, but not directly by the study drug. An adverse event may also be the result of a mistake made by the study team. In any case, researchers and those who regulate clinical trials are always on the lookout for adverse events - for lots of reasons. They may indicate that the drug or device being studied has side effects that may prove to be so significant that marketing, or even approval for marketing, becomes impossible. They may pose severe liability issues for the clinical trial sponsor. Most importantly, they are a sign that participants in the clinical trial are experiencing unwanted effects.
Existing federal regulations governing clinical research require all adverse events to be reported to IRBs - Institutional Review Boards that are responsible for reviewing, approving, and monitoring clinical trials at an institution such as a medical school or private clinic. As researchers and clinical trial sponsors have become more and more compliant with the reporting requirements due in some measure to enhanced FDA scrutiny, IRBs have become deluged with individual reports of adverse events. Such reports are often difficult, if not impossible to assess without analyzing the individual adverse event in the context of the entire clinical trial.
Even the existing definition of an adverse event as an "unanticipated problem" does not always help. While a severe headache may be considered an adverse event requiring reporting in a clinical trial of a drug for treating migraine, a single such report does not enable an IRB to determine whether or not there are global implications for the safety of research participants. Only if it became clear that severe headaches were being experienced by the research participants who received the study drug more often that those who received placebo and more often than the general population of migraine sufferers would it make sense for an IRB to consider taking some action regarding the study.
Next Time: What the FDA Guidelines are Recommending
~Joe
Related Topics: Technorati Tags: clincial trials, adverse events, FDA, health and wellness
In the world of clinical research the term "adverse events" refers to things that go wrong during a clinical trial. An adverse event may be caused by the drug or device being studied. It may be caused by the clinical trial itself, but not directly by the study drug. An adverse event may also be the result of a mistake made by the study team. In any case, researchers and those who regulate clinical trials are always on the lookout for adverse events - for lots of reasons. They may indicate that the drug or device being studied has side effects that may prove to be so significant that marketing, or even approval for marketing, becomes impossible. They may pose severe liability issues for the clinical trial sponsor. Most importantly, they are a sign that participants in the clinical trial are experiencing unwanted effects.
Existing federal regulations governing clinical research require all adverse events to be reported to IRBs - Institutional Review Boards that are responsible for reviewing, approving, and monitoring clinical trials at an institution such as a medical school or private clinic. As researchers and clinical trial sponsors have become more and more compliant with the reporting requirements due in some measure to enhanced FDA scrutiny, IRBs have become deluged with individual reports of adverse events. Such reports are often difficult, if not impossible to assess without analyzing the individual adverse event in the context of the entire clinical trial.
Even the existing definition of an adverse event as an "unanticipated problem" does not always help. While a severe headache may be considered an adverse event requiring reporting in a clinical trial of a drug for treating migraine, a single such report does not enable an IRB to determine whether or not there are global implications for the safety of research participants. Only if it became clear that severe headaches were being experienced by the research participants who received the study drug more often that those who received placebo and more often than the general population of migraine sufferers would it make sense for an IRB to consider taking some action regarding the study.
Next Time: What the FDA Guidelines are Recommending
~Joe
Related Topics: Technorati Tags: clincial trials, adverse events, FDA, health and wellness
