Is Something Better than Nothing?


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-03-01-2007
Volume 0
Issue 0

The fate of a new bird flu vaccine that provides limited protection rests in the hands of FDA.

Just as this issue was going to press, news broke out of Washington, DC, that a federal health advisory panel was urging the FDA to approve a bird flu vaccine undergoing clinical trials even though research shows it is effective in about only half of all adults. Panel member Dr. Robert Couch of Baylor College of Medicine in Houston says: "Anything is better than nothing." The panel voted to recommend that the FDA approve the shot and indicated they believe the vaccine maker, sanofi-aventis, could play an important role in protecting against a possible pandemic despite the vaccine's limited effectiveness. The vaccine, which is being

Stockpiled for use by government and emergency workers, protected 45% of adults who received the highest dose. That's well short of the FDA's desired protective rate of 70%. (Regular flu shots protect 75% to 90% of vaccinated adults under age 65.)

Robert Davidson

Norman Baylor, director of the FDA's vaccine office, echoed the sentiments of Dr. Couch. Baylor said the benefit of at least having a licensed vaccine against a possible pandemic flu strain outweighs the disadvantages of not having a flu vaccine at all.

In the trial, protective effects were observed in patients who received two 90-microgram doses of sanofi's H5N1 vaccine. The company says studies are already underway to look into the use of immune boosters to help increase the vaccine's effectiveness.

It's a no-brainer that we would be wise to take advantage of protection, albeit imperfect, when we have no alternative. This interim solution, however, should not in any way detract from current and future efforts to develop a more efficacious vaccine against the deadly bird flu.

Quickly developing more effective treatments against diseases like the avian flu is the thrust of the articles in our EDC & Information Technology supplement this month.

The supplement covers innovative techniques such as adaptive trial designs, which approach clinical trials with flexibility. These novel strategies continually analyze and monitor unblinded study data separately from the main trial. If enrollment is not sufficient to reach a desired endpoint, data collection technologies help expand or extend the studies.

The way patient reported outcomes (PRO) data is gathered is also becoming more efficient. And the EDC supplement covers the latest electronic PRO technologies (ePRO) that are making this possible, their regulations, and the convenience and speed they afford. Today's products are more user friendly than ever—portending more widespread use moving forward.

Finally, the supplement offers strategies for using business measures to select the best technology for clinical research. It's a unique take on how to find the right technology for a clinical program.

With continuing advances in information technology and data collection, more effective drugs are likely to result.

Robert Davidson

Managing Editor


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