Clinical trial sites put quite a lot of time and efforts to initiate a trial – depending on the country, they review trial-related documentation, facilitate preparation of site-specific versions, prepare local ethics / review board submissions, allocate resources for trial-specific trainings, develop site-specific budgets and contracts, etc.

All these pre-initiation activities are the service that shall be paid, even if a trial was not initiated due to sponsor’s decision or regulatory hold off. This study cost is known as Start-up fee.

Why is it so important to consider start-up fee at stage of budget creation?

Let’s be blunt – high-level trial budget developed by the sponsors (especially in case of ‘huge’ trials involving a lot of countries) usually doesn’t pay much attention to the start-up fee. It can contain something very average or not consider start-up fee as such.

When this high-level budget reaches the local specialist’s desk, it’s very important to check what is suggested as a start-up fee. It can be either too high or too low, so it is important to keep the fair market value amounts in mind during negotiation.

For instance, if we have USD 5000 as a start-up fee for the North America, there are high chances that during the negotiations the site will request to triple this amount, and local negotiator will have to go to sponsor for approval, and reasonable feedback can be ‘Why didn’t you flag this to us at preparation stage?’

Same USD 5000 for, say, Easter Europe can be too high, and shouldn’t be proposed to the sites. Otherwise in future trials there can be issues with offering a more realistic lower amount.

Another point – start-up fee motivates sites to put as much efforts for the trial initiation as possible. A site is confident these efforts will be rewarded even if the trial will never be initiated due to reasons the site cannot control.

It goes without saying, that as in any other item of negotiation, site’s requests to increase the start-up fee should have a strong rationale. Sites usually don’t provide the detailed breakdown of start-up services; however, it can be sponsor’s requirement. Some sponsors require this breakdown to see if contract review fee is listed as this fee can be treated as ‘highly discouraged’, yet it is unavoidable in some regions.

Thus, again, the global approach shall always be adjusted to the local knowledge. This is exactly what we, CTA Focus, do every day.