Word: trialing
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Dates: during 2000-2009
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...appeared to have, says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "When you lose statistical power, something that would have been significant in the [original, larger] population, could now fall below significance merely by the lower numbers. That's what happened with this trial," Fauci says...
According to Fauci, however, the trial was not designed to license the vaccine but to test whether the concept of using the two vaccines in sequence would work. In the latter condition, statisticians say scientists generally consider all data from the complete, original population, since these numbers more accurately reflect what might happen in the real world. In other words, it's a more rigorous analysis of how effective a vaccine might be in a population of people who, realistically, could be exposed to HIV before they finish the full six doses of the vaccine...
...does this mean the vaccine was not effective? That depends on whom you ask. Some experts argue that the vaccine's effect, if it exists, is so tiny that it's not worth pursuing in a significant way. They also question whether such a large trial can be considered as a proof of concept. "Doing a 16,000-person trial, it can't be a proof of concept at that point," says Dr. David Ho, director of the Aaron Diamond AIDS Research Center in New York City. "Would I invest in it? The answer is no. There are other things...
Still, the manner in which the trial results were released raised suspicions among some in the AIDS-research community. Scientific results are generally vetted in a two-step process: first, they are published in a peer-reviewed journal, which means a panel of scientists has reviewed and evaluated the validity of the study's methods and the authors' conclusions before publication; once published, other research groups repeat or analyze the data in more depth to further ensure that they are legitimate. The results of the AIDS-vaccine trial did not benefit from either leg of this process. The investigators chose...
From the outset, the vaccine strategy used in the NIH and U.S. Army study - giving two older vaccines in succession - has been controversial. In previous trials, each vaccine had failed to provide any protection against HIV, and in September 2004 a group of adamant scientists wrote a letter to Science arguing that the National Institute of Allergy and Infectious Diseases should not to continue with the trial. "We seriously question whether it is sensible now to conduct a ... trial that, in our opinion, is no more likely to generate a meaningful level of protection against infection or disease," they wrote...