The staff of biotech companies do not run clinical trials.
If they did so the trial results would become vulnerable to accusations of bias and hence have little value. For this reason It is extremely important that the company be seen as completely divorced from the operational aspects of any trial and the determination of its primary results.
If you look at one of our trial websites you will find Neuren to be listed as that trial’s Sponsor – meaning that its function during that period is to sponsor the trial by meeting its costs. Why it is prepared to meet those costs is obvious.
To achieve independence, a biotech selects a CRO (Contract Research Organisation) to manage the operational aspects of a clinical trial. This includes interactions with the highly qualified clinical research personnel at the various hospitals and clinics chosen, management of associated data and reporting of primary results back to the company. It is important that the company be seen as completely independent of these operations.
The clinical research personnel see the process as a research project and will publish aspects of the trial in full detail in the international research literature to contribute to knowledge in the area. This peer review process adds strength to the company's regulatory applications.
In terms of human resources, it is necessary that the company has at least one suitably qualified and clinically experienced officer on staff to drive the initial detailed planning of its trials, any in-trial modifications if required, and in the eventual analysis, interpretation and reporting of the significance of their results.
Hence the company’s internal staffing requirements should be no different if it were to sponsor one trial or four trials running consecutively (Neuren has had four Phase II trials running consecutively). The difference, of course, is that four trials would require four times the funds necessary for outsourcing.
Hope the above helps to settle concerns about staffing requirements.
Cheers
T7
NEU Price at posting:
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