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Re: hodge14 post# 10354

Friday, 05/16/2014 9:35:00 AM

Friday, May 16, 2014 9:35:00 AM

Post# of 725428
Hodge, GREAT POINT! I share the same thoughts. For a trial dedicated to testing safety with such a small population, communicating on a case by case basis is probably the BEST way of presenting the information.

- Analyzing "averages" or "medians" is not applicable when you only have 6 patients worth of data. Any one patient could SKEW the results significantly.

- In addition, every patient's situation is different. Analyzing by % is incorrect without a large population size because it assumes all patients are equal.


Lastly, in regards to Case Studies...I actually feel this is the most ethical way to present this data in this trial. This is not a trial that is enrolling 36 colon cancer patients. This is a trial that has 36 individuals from all cross sections of Stage IV inoperable cancers. Presenting each in a case by case basis is actually far more reliable than if they were to blanket all of them in to one report. For instance, if they said that 80% of participants had 50% shrinkage of tumors injected but if you actually analyzed the data for yourself you find that all 6 of the melanoma patients had NO response, it would seem like a misleading report. The case study analysis will give you a glimpse in to each cross section of the study. I anticipate seeing maybe one patient from each group be highlighted in the case study assuming they have data available for each.



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