Biotech companies do not undertake clinical trials. They contract an independent clinical research organization (CRO) to provide the required expertise. The trial protocol, and analysis and reporting of its results are the responsibility of the CRO.
IITRI was the CRO in this case. The decision to exclude two animals from the analysis would have been IITRI’s based on its expertise, as would the choice of format for its report.
The author of the RCE announcement does not appear to completely understand the trial details as reported, which likely is why the significance of the results were not made clearer to its readers.
The trial consisted of five groups of eight hamsters, the five groups being shown to the right of the supplied results chart. The two animals excluded from the trial therefore were from a group of eight and not from five as reported in the announcement.
The announcement also states that the viral load mean reductions of 1.5 logs and 1.25 logs were recorded on Day 4. The chart shows the log 1.5 reduction to have occurred on Day 2.
These minor points however do not compromise the validity of the results.
The main point though is that the Company would not have the option of selecting which animals should validly form the basis for the results reported.
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