UPDATE WEDS 6 MARCH 2013
I saw my doctor at UCLA today to fill out my "end of study" paperwork and questionnaire.
He said he received 2 letters just today, 1 from the DMC and the other from Nova RX.
1: The DMC said that the study was stopped for "futility". It was not going to meet its primary endpoints no matter how long they ran the study.
2: Nova RX said there were "regional issues/variances" in the data. This was a worldwide study, and they found that in certain countries, people on Lucanix were not doing better than those on the placebo but in other regions and countries, which we assume to be the United States, people on Lucanix were doing better than those on placebo.
Because the DMC only looks at overall numbers of patients enrolled, they don't make the distinction for certain groups doing well and other groups not doing well. They stopped the study for futility based on statistics.
This could set up Lucanix to start a new Phase III study with different entrance criteria, perhaps just in the countries where Lucanix outperformed the placebo.
My doctor, who is involved in a lot of clinical trials, speculates that in certain countries, the standards are not as high and some doctors might have enrolled people who didn't meet the study entrance criteria. It was explained that at UCLA for instance, the pharmaceutical company (in this case NovaRX) pay UCLA a certain amount of $ per patient enrolled which covers the doctor, his assistants, lab tests and a small profit. In some countries, income from clinical trials could be a significant part of a doctor's/hospital's income which motivates them to enrol all the people they can in trials even if that person doesn't meet the entrance criteria. When this is done even by a few doctors, it invalidates the results from the trial on a worldwide basis. My doctor felt it very unlikely that people in the United States (for example) would have done better on Lucanix while people in country X or country Y didn't outperform the placebo. (hope this explanation is clear and makes sense ).
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