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CancerLynx - we prowl the net
October 30, 2000

Questions to Ask Before Signing Up For A Clinical Trial
(from the Patient's Viewpoint)

Alexandra Andrews, Jim Carlson, Nancy Chinn (Rasa Lila), Karen Gann, Bill Hodnett, Karolen I. Paularena, Linda Trenholm, Mike Wickson

1. Will I be able to continue any other treatment?
For me, I always want to continue with my herceptin because I believe it's slowing down my cancer.
2. What phase is the trial in?
Personally I'd be willing to do a phase 3, but 1 or 2 at this point would be out of the question. I also know that will change as my disease progresses.
3. What have been the results of the earlier phases of the trial?
I sure would hope they'd talk. It's hard to understand how they can consider it an informed consent if they don't give you information. I would be pretty adamant about that before I signed the consent form.
4. Have there been any fatalities?
5. Who is sponsoring this trial? Is the trial sponsored by NCI or a drug company?
I'm somehow a little more leery of drug-company sponsored trials - I would worry about truth in results. Stats can be skewed depending on what data is collected (liars figure and figures lie)
6. Will I know what I'm getting?
7. If my cancer progresses, will I have the option of getting the other treatment?
For example, I was on the herceptin trial which was measuring herceptin with adriamycin and cytoxan against adriamycin and cytoxan alone. I was randomized to receive only the chemo without the herceptin but knew that if my cancer progressed, I would be able to get the herceptin. Which is what happened.
8. How do you evaluate whether the trial is working or not?
9. How many participants do you need before you move on to the next phase?
10. How long will you follow the participants?
If there are long term side effects, what will you do?
11. What exactly will the trial people cover regarding the expenses?
Sometimes they cover nothing, sometimes only the drug in question, sometimes (as in many NCI trials) everything including travel expenses.
12. Do I have to go to your institution to do the trial or can I do it under my doctor's supervision where I am?
Sometimes they insist only that you go there periodically for testing...if so, how often and how much of the testing can I do in my own medical office? For example, with the herceptin trial, I had to do MRIS and bone scans every three months which I got done at Kaiser under my insurance. Only things I did at the University where the trial was were the blood tests which they covered and got the treatment which they covered. Actually when I was on the chemo leg of the trial, I got that done at Kaiser too--they just faxed over the protocol.
13. What were the results of the animal tests?
14. How common are the side effects, ie what percentage of people are expected to get cardiac toxicity, etc.
Usually you get a whole long list of side effects but have no idea how common they are.
15. What is your feeling about this trial? Are you excited about it?
I always ask this because it tells a lot to me. I went to DC to NCI to interview for a vaccine trial there and the principal investigator seemed so bored with it all that I thought forget it, there's no way I'm going to do it. Whereas the vaccine trial I tried so hard to get into in Detroit was just the opposite, the researcher was so excited about it. I want to be in a trial that the researchers are very excited about, that they feel is more than just an idle experiment.
16. Is there a subset of people that you think the trial will be better for?
young, old, premenopausal, postmenopausal, organs only mets, bones only mets, aggressive tumors, slow growing tumors, etc.
17. Is there a subset of people you will not allow to enter this trial.
For instance Inflammatory Breast Cancer patients are usually not allowed into Breast Cancer Trials. Considering IBC patients are treated according to the results of these trials, using the trial data seems suspect.

18. Will participating in this trial cause me to be unable to enter other trials in the future?
I'm often worried about getting into some kind of trial too early because they haven't really gotten it together and then when a more sophisticated right on trial comes along, I may not be able to get into it. You know like my taking herceptin exempts me from certain other monoclonal antibody trials.
19. Do you accept financial responsibility, if I am physically harmed such as recieving third degree burns or I die because of this trial?
20. Is the risk of the trial great enough to reduce the quality of life we have left vs the quality of life if we don't participate?
21. What is the expected outcome of this trial?
22. Are you using placebos in this trial? If my cancer progresses will I be given the drug itself?
23. Are you using the old method plus the new.
As in the modern sentinel lymph node biopsy plus the old removal of all the lymph nodes. Why are you using both procedures?
24. Dear Dr. knowing what choices there are for me out there do you believe in your heart that this trial is the best option for me at this moment?

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