On the hop ddwn. As a general rule trial sites are spectacularly...

On the hop ddwn.

As a general rule trial sites are spectacularly uninterested in whether something works or not. But they are very interested in whether things work from the point of view of their hip pocket.

MSB have run out of money. So MSB has sold a little bit of itself to fund the next CLBP trial. If I am right that funding will swing around back to SurgCenter.

From a trial perspective this has a upside and downside.

By creating a financial link to trial sites (where SurgCenter are now MSB shareholders) and trial outcomes in theory this should lead to higher quality implementation.

It will also tend to move you along a notch from efficacy to effectiveness. This is because the trial is taking place in real world treatment centres (not ivory tower academic research institutions) with “run of the mill” patients.

The external validity of the findings increases but nearly inevitably the internal validity will suffer.

The CLBP P2 trial is example of this. Investigators were not blinded to treatment allocation; presumably because of the difficulty of achieving this in the context of the real world clinic environment here - very small centres scattered across the US.

So you have a threat to internal validity; but improved external validity – if those centres could achieve positive results then this would be very translatable.

The catch is the FDA is much more focused on internal validity than external validity. Whether MSB can spot and anticipate this danger - that the context is going to operate to weaken internal validity – is the question.

In some ways it might not matter. At the end of the day … the clinical trial stuff for FDA approval might not be where the action ends up. It is possible they can sell their treatments to people directly; without the FDA. That might be a smarter way to go; with the lower level evidence from their trials as marketing.