Randomization of patients over a span of 3 years, across 14 locations, multiple ICUs, multiple investigators & nurses, it would be difficult for one investigator at the ICU level to come to a conclusion about the effectiveness of Cytosorb overall.
As for enrollment pace, Dr Chan has responded in an email to some posters regarding this:
May 2010:
"Please keep in mind that most clinical trials in Germany in April are impacted by the Easter holiday and spring vacation where many investigators and study nurses take two, even three weeks off for vacation. "
Jan 2010:
"November was a stellar month for us in terms of recruitment, our all time high. I think if it were not for the December holiday vacation season where most doctors go away, clinical trials are deprioritized as the hospitals are short-staffed, and nothing really happens, we would have seen much higher numbers. Because of this, it is not appropriate to take an average monthly enrollment. We now have 14 sites actively screening patients and in November saw the strategy of increasing the number of sites starting to pay off. January is starting to pick up again."
2009:
"In terms of the pace of recruitment, please recognize that clinical trial recruitment is one of the major bottlenecks in every clinical trial. There are many factors that impact recruitment, many of which are outside the direct control of the sponsor. Many clinical trials involve recruiting outpatients with common diseases like hypertension and diabetes and are much easier to enroll. Hospital-based trials are harder because you can't predict when patients will present with the disease you are studying. Critical care-based trials are even more complex than studies done on general ward patients because instead of having 500-750 beds to choose patients from, ICUs tend to be much smaller with 15-60 beds per hospital often split up between the Medical Intensive Care Unit, the Cardiac ICU, the Surgical ICU, the Trauma ICU, the Neurologic ICU, etc. Also, critical care therapies are often life or death trials with a host of related concerns such as informed consent and other issues. Although severe sepsis and septic shock patients make up approximately 20% of ICU admissions, having those patients meet your criteria for enrollment into the trial (called inclusion and exclusion criteria) can often be difficult, particularly from a timing standpoint and exclusion criteria standpoint. You can see our criteria here: http://www.clinicaltrials.gov/ct2/show/N...
So one of the major issues is that enrollment is a numbers game. This is why we have significantly expanded our clinical trial sites and are working to increase the number of sites above 12. To bring a trial site on board is a long process requiring interest at the principal investigator level, all the way down to the study nurse, contract negotiation, ethics committee approval, site initiation, etc. And there is always some degree of inertia as the trial site warms up to the protocol and trial. Then there are always a number of issues that arise from physician turnover, equipment issues, to things as mundane as vacation. "
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