Ethical Question?

[RobertBeWell]

Let's say one had an opportunity to participate in a research trial. There are several sites one could travel to, all about the same cost and convenience. Let's further say that one of the sites was behind the other two as far as getting the program up and running, and you have some concerns about slots filling up.

Is it expected that the patient will do what is in their best interest, including applying to multiple study sites to ensure the best chance of getting in?

I haven't done this yet, but it's a real possibility. The site I have been talking with for the past month is really dragging their feet, and several others are already recruiting. I have paperwork available to apply to all three.

Should I apply to the other two, and take whoever can get me in first? Not sure about this, I don't want to foul anything up and hurt my chances of getting in.

Now that I read back over this, I'm not so sure it's an "ethical" question so much as a "procedural" question. After all, I can simply decline to participate if and when the "stragglers" finally get their program running. Isn't that right?

Thanks for opinions.

[Kristina538]

Go for it Robert - apply for all three.  What you are doing is proactively strategic, and born of good research;  you deserve to make the best of the efforts you've put in, and as NYGirl said, the spots will be filled.  Good luck.

[uncledudeness]

jump in with both feet and take no prisoners Rob.....come on TX partner, I can't do this on my own....lol.... just tell them you have a friend that's in the same trial and he 'knows people'....i really do live about 5 miles from BMS, so I could go over there and be a pest; you know, block traffic, picket them, throw eggs at their cars....moon them....

all kidding aside, you do what's best for you...

i hope the next call I get will be to come in and start TX...I'll let ya know.

[RobertBeWell]

Yes, I am feeling very comfortable with multiple screenings. I'm looking at it as a chance to "interview" the study site. Are they prompt and courteous? Do they have it together? Are they professional? Are they willing to make things easy for the patient? Do they respond quickly and thoroughly to concerns?

These are all things I am going to be looking at when I go for screenings. They think they are screening me - but I'm really interviewing them for a job - the job of curing my disease :-)

Copyman, your advice is well-taken. The thing with me is, I'm willing to take a chance on that, since I'm stage 1 and it's not gonna be a huge deal for me if I don't get in this time. There will be dozens of studies coming up. Of course, I will not lie on the form. It's just a personal peeve of mind that I never lie at all. About anything.

I called my insurance company too - it seems there may be a chance that they will pay for my travel. I told them I was thinking of saving them about $35,000 clams and they perked right up LOL.

Thanks again for all the advice!

Robert

[Deb9991]

You are not legally bound to any one of them (unless you've signed a contract) -- so, it is not an ethical question, but a question about what is most correct and proper for you.  Remember, if for whatever reason they didn't want you, you'd be out.  So, taking that into consideration, you go with the one you want, if you can, and don't worry about the others.  There are plenty of additional people who can take your slot if you choose against a particular study, as was mentioned above.  Do what is convenient for you.  There are many variables to consider.  Apply to all of them -- there is nothing wrong with that either.

The bottom line -- it is your health.  You owe no allegience to any study, nor do they owe any allegience to you -- they just want results.  You are not a person to them, by a lab result -- but it is for the sake of science and it is necessary.  Try for the one you feel is the right one for you, such as location, convenience, etc.  If the right one doesn't work out, go with the next one.  

You'll get the right one that meets your own criteria.  And it sounds like they are all right -- but some are dragging their feet, and that can be really annoying.  

Debbie  

[copyman]

I wouldn't take the chance.

The other thing that could happen is you are excluded for submitting applications for all 3 studies. I believe one of the questions asked during screenings was if I had applied to another study. They make it clear that if you lie about anything you will not be accepted. They made it a point to say each site was getting only 10 participants and they have dozens that want to get in. Just a thought.

[RobertBeWell]

Thanks to all for the valuable feedback. I feel, like, 1000% better about this now. Actually, I already have one screening set up in Denver. They reviewed my medical records, and said I was an excellent candidate, so I don't see any reason why the second site won't be inviting me in for a screening in the near future.

Just for the record, the "straggler" site I spoke of is not being held up by the drug company - they tell me their "internal review board" has to approve the study, so it's an internal matter.

The other two sites I'm looking at included documents in their packets they sent to me that indicate THEIR internal review boards went over and approved this trial MONTHS ago. Now whether that is because they had the information sooner or not I don't know... but at the current time, the straggler is being held up by an internal process. Of course, review processes are intended to protect both patient and institution - so I'm not complaining or judging - just documenting.

Thanks again!

[can-do-man]

Robert theres a good chance that its not the treating site but the drug company holding things up as they have to give the final approval to each site. Where i treated we were one of the last to get started....... Plus once they give a site the final ok theres a time limit to fill their slots or the place looses them. So then the site has to hurry things along.

Good luck and do what you gotta do guy.

cando

[spectda]

I spoke with two sites for the same boceprevir study. They both collected all of my documents and decided I would be a good candidate if my hgb was at the correct starting level for this anemia study.

One of the sites had me test for hgb privately and it was too high a couple of times so they wouldn't screen me. The other location screened me twice and the second time I had the correct hgb.

Take care of yourself first-Dave

[FlGuy]

a very long time ago there was a discusion about approaches that patients should have when pursuing a trial. most of the decisions by the trial people is objective, whether a person passes the inclusion/exclusion criteria and if the person has ability to follow a rather strict protocol.  the discussion at the time was wheter a knowledgeable hepper should display his knowledge about the disease or to pretend that he is a somewhat informed garden variety patient who displays the ability to understand the committment and to follow instructions as stated.  trial people don't necessarily want smart and informed people as much as they want compliant people.

[CoStudy]

If you get accepted by all 3 and invited to the screen do it. Like I said there are a ton of other people that want in on the same study. Once you have screened, if you are accepted by all three go buy a lottery ticket and then chose the site that you are most comfortable with. The other sites will fill your vacated spot very fast. This is your disease, do what you need to do to fix. Besides, the screenings are free!

[RobertBeWell]

You know, that's a very good point about having it together... didn't really think of it that way. There is one site in particular that is really responsive.

nygirl, I guess I just kind of felt "obligated" to the "dragger" since I spoke with them over a month ago. Silly, huh?

So now that I know I'm going to apply at more than one... the next step after they review your records is to bring you in for a screening visit.

What if I get to the "screening" stage with all three? Schedule three screenings? I suppose it WOULD give me a chance to see and interview site personally.

Hmm, I like this idea more and more! As always, the SUPER FOLKS on this forum have provided me a new learning experience! You guys are GREAT! I only hope I can give back as much when I become a treatment "silverback" :-)

Robert

[nygirl7]

Now THAT was good advice.

[CoStudy]

I would apply for all 3. Some test sites drag their feet due to procedures not being completely defined by the pharmaceutical company paying for the study while other test site get the slots filled asap and then wait for the pharmaceutical company to finalize the procedures. One procedure are finalized, all sites have to follow the same procedure. If not the do not receive the funding from the pharmaceutical companies the need to stay in business. By signing up for all three you stand a better chance of getting into at least one of the sites. If you get accepted by more than one, you can pick the site that best fits you. You have to keep in mind you and about 1000+ other people also want in the study. Don’t miss your chance. If you get accepted by more than one and chose not to be in the study, the study sites put you at the top of the list for the next study they receive. Good luck and be proactive. I turned down 2 opportunities to be in studies because of timing. I stayed in touch with the study site and they kept me informed as to when studies were about to published. I was #1 on the list for the Lambda study for G2. Thank God!

[FlGuy]

it's Saturday night and you are at a bar hoping the evening ends well. you set your eyes on a pretty young thing and she has your attention.  fast-forward a few hours, it's almost closing time and you might be heading home alone, the pretty young thing is draped all over someone else. over in the corner is someone you had seen earlier in the evening by dismissed for some reason...
the drug companies know the windows of time during which a center must recruit, test and compile in order to meet the overall timetable for the trial. i don't think it's at all significant that one center is ahead of other.  places that do a lot of trials need to juggle their resources to meet a bunch of schedules.
find the site that meets more of your needs and pursue that one with energy but without being a p.i.a.  you can't hit on three girls and expect to connect with all.  focus on the one you want.  don't know the one you want?  figure it out.

[Diane12855]

nygirl7 has a point. The ones that are stragglers probably won't be as on top of things down the road either. I wouldn't want them to manage my tx.

I doubt that anyone would hold the fact that you are putting your health first against you. Sign up for any that you think will help you get well.

Diane

[nygirl7]

Why would you not go to the best site - the guys that have it together the most over waiting for those who aren't as put together?

[Trinity4]

If you were choosen for all three and declined 2, rest assured those spots would be filled immediately.  Do what you have to do Robert, I certainly would.

Trinity

[RobertBeWell]

In case it wasn't clear, I am referring to the SAME STUDY, just multiple study sites. Their all for the same drug.

[nygirl7]

When it comes to your health do what is in your best interest.  No doubt about that. Make  sure you pick the one you think will give you the best attention and the best chance at beating this disease. Not everyone will be as proactive as you are and so should you be punished for being so thorough? no. Definitely not.