question re clinical trial and medical records

I could've sworn I already posted this but it seems to have disappeared...The consent form says that the study doctor will need to use....(among many other things) "new and existing medical records".

I need to know if they really ask for, or can get their hands on my prior medical records. If so, is this from the health insurance company or my PCP?

I would really appreciate anyone who participated in a trial to let me know. Somehow, I can't imagine them actually accessing my medical records from the past but I really need to know.

Thanks...

[curiouslady1]

Yes.  They want to know what your medical history is.  There are some conditions that would bar some people from trials.  You would have to sign a release from your PCP and have the records sent.  In some cases, new tests have to be done by your physician and charged to your own insurance or pocketbook before they will consider you.  In my case, I had to have a cardio-stress test and an eye exam by an opthalmologist since the rescue involved interferon with known effects on the eyes in some people.  I had already done the eye exam within the year and so it was part of my medical record.  It happened that it was done at the same hospital complex in which I had my trial.  There was automatic access in that case I think, as soon as I told them where to find it.  

[katla]

I already went to a cardiologist and ophthalmologist and was cleared so I have no problem with that. And I'll bring them the biopsy report.

What I need to know is what they can get from my pcp and how that works. I'm fine if they get  the hcv blood tests etc., but there are things in my file w/pcp that they can't see. Do you know how the process works? It's quite important, thanks.

[can-do-man]

Well i was in a trial and they never asked for all that, they did their own test for what they needed to know.

[curiouslady1]

I would discuss it with the PCP.  You find out what the researchers want, sign a release with your PCP for just that information and your PCPs office sends it to whoever you ask them to send it to.  If your PCP releases more than what you authorize him/her to release, they are liable.

If, perchance, the researchers want more than you are willing to provide, you take the risk of being excluded from the study although I can't imagine what that might be for the particular trial you are interested in.

I do know that someone told me a friend of theirs who had recent bariatric surgery was excluded but don't know if that was the reason.  

I was never asked if I had mental health records etc. It wouldn't matter if you had a history of alcoholism or drug abuse because they are going to do a full out substance use screening before you start.  Any indication you are not clean at the time of the screen, you are out.    

One thing you do have to provide and it has to be very accurate and precise is your list of current medications and supplements.  Some medications and supplements you can continue to take.  But some you have to give up for the period of the trial.  

[katla]

Thanks very much!

[suezeeque]

None of my prior records were sent prior to my participation in a trial.  I had been referred to the hospital clinic where the trial took place about 9 months prior to being offered to participate in the study.  All they had was what the GI sent who referred me.  I had already provided consent for those records to be sent when referred.

Any testing they required be done before acceptance into the trial was done at the hospital at the expense of the drug company.  I wasn't asked to do anything on my own at all.