In my October 24, 2006 posting below, entitled "How Magic Happens", I cite an article by Dr. Jerome Groopman about research concerning preeclampsia that was conducted by scientists at BIDMC. This is a serious disease, a major cause of maternal and perinatal death and morbidity worldwide, but especially in developing countries. Because of the importance of the disease, public health officials around the world hope for rapid clinical applications of the recent discoveries.
In that vein, I learned this week of a clinical trial being undertaken by the World Health Organization as part of a collaborative effort with several institutions around the world. The trials derive directly from the research described in Jerry's article. The idea is to determine whether simple urine and blood tests can be used to identify women at risk for this disease. The trial is being carried out in several countries, and the hope is to evaluate this procedure in over 12,000 women who have risk factors for the disease.
The idea is straightforward. If simple tests during early pregnancy can indicate which women are more likely to get the disease, their pregnancy can be closely monitored and their symptoms alleviated rapidly when they occur -- reducing the chance of death or injury to the mother and the baby. As noted in the summary:
If as we hypothesize, this large prospective study convincingly demonstrates that urinary ... and serum ... bio-markers predict preeclampsia, with a high degree of sensitivity and specificity, and weeks prior to overt disease, we will focus on the best way to implement the use of these easily performed and affordable tests in developing nations.
Read through the minutes of the cooperative group to get a sense of how these scientists are designing the trial and the considerations they must examine to make sure it is scientifically valid and useful. The minutes give you a feeling for the enthusiasm with which these doctors approach the trial and also for their underlying wish that it will be successful.
It is always tempting to have great hopes for clinical trials, and we shouldn't permit ourselves to get ahead of the results. That being said, if this trial is conclusive, this is a big deal for the entire world. We all wish them great success.