FDA rule opens door to clinical-trial safety info

The rule clarifies how problems are reported in drugs that are being tested.


The U.S. Food and Drug Administration issued a final rule on Tuesday that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics such as vaccines, allergenics and gene therapy.

"This final rule will expedite FDA's review of critical safety information and help the agency monitor the safety of investigational drugs and biologics," said Dr. Rachel Behrman, associate director for medical policy in the Center for Drug Evaluation and Research. "These changes will better protect people who are enrolled in clinical trials."

It also clarifies the information coming out of clinical trials, said Kathleen Obenland of Providence St. Mary Medical Center, which runs some clinical trials at its cancer center.

Those can include treatment trails for breast cancer, lymphoma, non-small cell lung cancer, prostate cancer, sarcoma, gastrointestinal, gynecological cancer, leukemia, and small-cell lung cancer, Obenland said. "We do not do any Phase 1 trials, which are the first phase of testing on human subjects.

"The trials we participate in test the current, most effective treatment against new treatments, approaches or combination of treatments that have already shown effectiveness and promise in earlier trials. The study often is randomized, so patients don't know whether they are receiving the best-known treatment to date, or the new one. But either way, their cancer is vigorously treated."

The new FDA rule requires certain safety information that previously was not required to be reported to the agency now be reported within 15 days of becoming aware of an occurrence. These reports include:

Findings from clinical or epidemiological studies that suggest a significant risk to study participants.

Serious suspected adverse reactions that occur at a rate higher than expected.

Serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream, and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand-name drug.

The rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under current regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event.

Even things like car accidents or unrelated medical issues get mixed into the data at present, Obenland pointed out. "Even if it has no possible consequence to the medical trial."

Such reporting complicates and delays the FDA's ability to detect a safety signal. The examples address when a single event should be reported or when there is need to wait for more than one occurrence.

The rule also revises definitions and reporting standards so that they are more consistent with similar international organizations. The changes are designed to help ensure harmonized reporting of globally conducted clinical trials.

The new ruling is not likely to impact Walla Walla area patients in the immediate future, but improve clinical trial information in a global sense, Obenland noted.

Sheila Hagar can be reached at sheilahagar@wwub.com or 526-8322. Check out her blog at blogs.ublabs.org/fromthestorageroom.


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