question on clinical trial

[paulw1283]

Hi, I've developed a small medical device. I need a clinical trial to get FDA approval. I've contacted an university hospital/research center and they are interested in conducting the clinical trial. But I haven't called them back yet.

My question is, how much would such a clinical trial cost? It's not a complex medication that requires years of trials, but a simple medical device that just requires a simple yet formal trial that only lasts maybe 2 month. Either way I'm guessing it will be pretty expensive right?

So I was wondering if it's ok to propose to them to conduct the clinical trial for me for free and I will share the profit with them. They are a center that specializes in patients that need this so marketing and everything would be easy for them. Would such a joint venture idea be feasible or is it ridiculous?

Thanks

[HarveyJ]

I've nevr done one either, but logically speaking, there's no way to give a fixed cost to something like this as there are so many variables.
You'd need to know how many units they want, plus redundancies, over how many weeks, etc etc.

[Fanatik]

Paul, I assume you're intelligent based on your invention (a medical device of all things). This being the case, it would seem that you'd be apt to contact SCORE, ask for a medical professional or a similarly experienced person, ask them some questions on how the trials work, formalities, cost, etc.

Then I'd call that university and speak to the head of the dept; arrange a sit-down and take a list of questions so you can formulate a plan. It will be a joint venture with you and the U since they'll be administering the trial. That said - they should have the resources you'd need to get this thing rolling. They've done plenty of trails I'd assume, so they should know the steps involved in funding, etc.

Just a thought - but if you've created a medical device for market, it'd seem like you'd have a decent bit of ground work already laid out. I'd start doing as much research as I can about trails, the cost, effects, pitfalls, etc...

Best of luck.

J