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An important clinical trails policy announcement has just come out that could affect those currently undertaking trials in the US. The department of Health and Human Services (HHS) released new guidelines on clinical trials reporting in the US indicating that all ‘unanticipated problems’ occurring in participants of a clinical trial sponsored or supported by HSS must be reported. More on this below.

This is likely the first in a wave of pending drug policy issues that will be fought over in Washington, stemming from the reauthorization of the Prescription Drug User Fee Act (PDUFA) (FDA financing). The new Democratic congress is set to address new measures that would restrict drug advertising and create a new office of drug safety to oversee post-approval monitoring. (Discussed previously here.) These and other issues will be hotly debated, and lobbied for and against, leading up to the reauthorization, without which the FDA’s drug regulation and approval process will grind to a halt by late summer. Expect the rhetoric to heat up as the temperature does the same.

But back to the new guidelines:

In particular, this guidance clarifies that only a small subset of adverse events occurring in human subjects participating in research are unanticipated problems that must be reported under 45 CFR part 46. The guidance is intended to help ensure that the review and reporting of unanticipated problems and adverse events occur in a timely, meaningful way so that human subjects can be better protected from avoidable harms while reducing unnecessary burden.

In this context, unanticipated problems, include any incident, experience, or outcome that meets all of the following criteria:

1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
2. Related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and;
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

The HHS regulations at 45 CFR part 46 do not define or use the term adverse event, nor is there a common definition of this term across government and non-government entities. In this guidance document, the term adverse event in general is used very broadly and includes any event meeting the following definition:

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).

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