rgc
I had the same concerns as you initially when they announced an expansion of a trial that they hadnt even started...and I spoke to someone in OSL on the "executive." They are not going to be paying for everything - that would be a huge cost. My impression was hopefully just the Oncosil provided and administration costs...and the rest is standard care that the "patient" or their provider pays for. If it came to paying costs for patient care related to the trial - then "we" have a huge problem.
OSL will still gain remuneration for OSL sales after IDE for those who elect to receive the product but not be part of the trial.
At this stage I dont know if the trial is double blind placebo controlled or just placebo controlled or historical controls. We will find out in due course but I suspect a lot of the financial discussions are commercial in confidence and you just have to trust the company most of whom who have a lot of "skin in the game"
In terms of whether this is unusual in terms of costings. My experience with oncology trials in the USA (admittedly early 1990s) was user pays standard care and that applies to more recent experience where I had some admin involvement in a public hospital - and they saw charging the trials as a way of generating income... It didnt happen (for the outpatients at least) - although I suspect it is on the cards in the future given the precarious funding state of public hospitals (many of whom are creating facilities to allow them to charge drug companies in this setting for in patient procedures at least).
It is a good question to ask the company - but at this stage we just dont know about the trial format. I
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