Clinical trials are set up in multiple phases, each level aimed at answering a specific question. The first question tackled with regards to devitalization testing, was whether the technique would result in sepsis. Phase one was successful in answering that question but - paradoxically - the Health Ministry prevented the trials from going on into phase two. So - it remains unknown whether or not the technique is useful as a cancer treatment. For now, doctors in the Czech Republic are not able to offer the devitalization of tumors as an option.
Patients, present at Thursday's meeting at Prague's town hall, feel that the government should not close the door to this treatment option. They want the clinical trials to be continued and they want this treatment to be made available, if only as a last resort.
Mr. Martin Tlusty the coordinator of the conference says that the trials were successful in their goal - to prove whether the treatment caused sepsis.
"The first stage of clinical tests of this method has finished. About 50 patients were operated on, but these patients were all in terminal stage of cancer. This means that these clinical tests, in fact, could not be used to prove the effect of this method but it was able to answer the question of whether sepsis could cause patient death."
And so, what were the results?
"There was a positive answer to the sepsis question. Not one of these patients died from sepsis so the expectation that while the tumor is dying inside of the body can kill the patient was not confirmed."
I thought that last month the clinical trial was cancelled?
"It is correct and we agree with the stopping of the first clinical tests because what they could prove, they proved. They could only test whether there would be sepsis of there would not be sepsis."
Do you expect the Ministry to allow the clinical trials to continue and go onto phase two?
"Yes- We believe it, I myself believe that they will continue. The question is whether these protocols will be optimal. But, we believe that the second stage of clinical tests will definitely start again."
Whether or not testing will continue is still an open question, one that seems reasonable considering phase one testing was not conclusive. Considering the seriousness of the disease involved, it is no wonder that the Czech Health ministry is giving the topic lengthy consideration - and contemplating the continuation of testing.
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