My sister-in-law has been asked to particapte in a Phase II trial of a gene therapy product called INGN 201 for people with "advanced resectable squamous cell carcinoma...)

My wife (in Kansas City with her sister)faxed me the information on the trial and I was wondering if anyone might have experiences with this product in particular, but also have some questions about clinical trials in general.

This products introduces a p53 gene during surgery and 2-3 days after surgery. Radiation and chemo will follow on a prescribed schedule. They are trying to determine if INGN 201 may reduce the percentage of recurrance of cancer.

There are likely side effects, the most concerning (to me) are infections at the injection site and drain tube.

Not being versed in the protocals of clinical trials, I was surprised that the expense for additional tests and examinations required by the trial are borne by the patient/insurance company and if the drug goes to market during the trial (unlikely) it would have to be purchased by the patient. Of course, her insurance company would have to approve.

Does this sound like standard procedure for a trial? I'm kind of surprised that they shift the additional financial burden to the patient.

I think her inclination might be to participate to try to make something positive come out of the experience, but I'm kind of wondering about adding to the financial load (they'll want to moniter her for five years) and the potential of additional side effects to the known ones from the surgery, radiation and chemo.

Any thoughts?

bob

This does seem somewhat odd, though not completly out f the realm of practice. Normally pharma companies have to pay hospitals to enroll patients in clinical trials. There is a lot of additional record keeping and montoring that is expensive. Two trials that I am watching on chemoprevention are actually paying patients to enroll, paying for the drugs, and paying the institutions that are doing the trials. If the patients had to accept the financial burden of the trial, nothing would ever get done in the world of new drug development. So I find this far from the norm. For myself I would have no issues calling Introgen Theraputics and finding out what their protocol for hospital participation is, are they or are they not paying the hospitals to do the trial, and if they are, my next call would be to the hospital administrator to find out what the deal is.... double dipping?

We now have more information about the trial. The hospital is compensated the the record keeping only. Patients are not required to take any tests that their doctor would not normally order, they just agree to share the results with the trial. Since it's a Phase II trial, the drug will not come to market during the trial and it is used during and right after the surgery only.

I guess they use standard "boilerplate" language for the information they give out and it created questions since we didn't have prior experience. My sister-in-law has decided to participate in the trial.

Thanks,

bob