This post isn't really about clinical trials in general, but about the latest one for the H1N1 virus. This is of course, the strain of flu that was formerly known as swine flu.
Previously I blogged about the data that had been gathered from the first wave of this virus and how it seemed to effect pregnant women most significantly. One reason for that is the suppression of the woman's immune system during her pregnancy, but another is the decrease in lung capacity and oxygen flow during the final month or two as the fetus' size impinges on the lungs. For these two reasons at least, the CDC and others are putting pregnant women at the top of the vaccine list. Problem is, we do not yet have that approved vaccine.
The makers of the seasonal flu vaccine have created an H1N1 version that is showing efficacy and safety in animals and people, during the clinical trials. The NIH is now supporting a trial of the vaccine on pregnant women. They are testing dose strength and dose frequency. Women have enrolled in the trial.
Yesterday there was some discussion of this on NPR and someone asked why a woman would volunteer for the trial. The scientist being interviewed explained why pregnant women would benefit from the vaccine, but not why they would risk themselves and their unborn child in a clinical trial whose aim it is to prove safety and efficacy.
I continue to scratch my head over the same question. I realize that someone has to do it, but there is no way it would be me. Would you participate in clinical trials? A vaccine one? One during pregnancy?
Most drugs are not tested in pregnant women and instead are reviewed when we find pregnant women who have taken them. I imagine the need for a vaccine in this target group is great, and I still do not know why I would participate in the trial.