The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Here is a question raised by a potential client that I thought would be of interest to other.
“We are considering study sites at a few major academic oncology centers in the US- how many sites do you propose would be sufficient for a Phase 1A study in all solid tumors and how quickly could the study sites open?”
Ideal number of sites:
This will be highly dependent on protocol design but a standard phase IA trial in ‘all comers’ solid tumors involve a maximum of 4 centers with the vast majority of trials revolving between 3-4 sites.
I must say that we have been noticing a recent trend for sponsors (with tight timelines) to increase the number of sites to 5 and even 7. The strategy being to have sites in a ‘ready state’ for the subsequent ‘expansion’ phase (Ib or 2a). This higher number of sites (5-7) is also more common when targeting single or multiple rare tumor populations (eg. Triple (-) Breast Ca, ALK+ NSCLC).
In our experience too few sites may delay recruitment and study completion, while too many sites may unintentionally ‘complexify’ cohort escalation management and study logistics. The important thing to consider is to recognize the risks at both spectrums and manage expectations with study team and investigators.
Major US Academic oncology centers may take between 6-9 months to start-up while those in Canada take between 3-5 months (US/Canada Start-up timelines tend to balance out in ‘later phase’ trials (2b and 3) when the use of community centers can be leveraged in the US).
One solution scenario that we find to be very efficient is a full North American approach that involves 1 or 2 US sites and 2 or 3 Canadian sites. This allows the team to leverage US KOL relationships while securing performance metrics (First Site/Region Initiated; First Patient In) that are of keen interest to investors.
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