Study Control Arms. Do we need so many Placebo's?

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Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 11/8/2008 3:53 PM (GMT -6)   
This is one of my writings at another site...Interested in your thoughts here at HW.
 
I looked into joining studies when I first was diagnosed, and in controlled studies there almost always are control arms that use placebo's or no treatment at all. To me this seems to be overly redundant in many cases. I know that many studies do require control arms in which the patient does not know whether they are receiving the real thing or not because of the mental factor, but we have enough acquired data of placebo cases to accomodate many studies without having to require yet another placebo control arm. The Alberiterone study is one such example. I have a friend who is no longer responding to chemotherapy, and he is trying to go on the Abiraterone study. But he does not know if he will get the drug or not, and he does not need a placebo at this stage of his treatment. We already know what not receiving the drug results will be through other studies. I saw a post on the blog page of TNPCIL that raised hope for a reduction of the need for placebo or no treatment arms, but if it were a vote, mine would be that there does not need to be so many such control arms, and if I have cancer it should be my choice to receive the experimental drug, as we already have enough gentleman who have chosen to watchful wait.
 
Perhaps maybe what we need is a registry for watchful waiting that has a questionaire of precisely how they are doing so, so that drug campanies and the FDA can pull it's data from there rather than making a study a crap shoot that is gathering repetitive data.
 
Just my thoughts. What are yours?
 
 
Tony


Age 46 (44 when Dx)
Pre-op PSA was 19.8
Surgery on Feb 16, 2007 @ The City of Hope
Post-Op Pathology: Gleason 4+3=7, positive margins, Extra Prostatic Extension (EPE)
Bilateral seminal vesicle invasion (SVI); Stage pT3b, N0, Mx
HT began in May, '07 with Lupron and Casodex 50mg (2 Year ADT)
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (September 17 '08): <0.1 ~ Undetectable!
 
You can visit my Journey at:
 
STAY POSITIVE!
 
 

Post Edited (TC-LasVegas) : 11/9/2008 9:16:26 PM (GMT-7)


livinadream
Veteran Member


Date Joined Apr 2008
Total Posts : 1382
   Posted 11/9/2008 6:08 AM (GMT -6)   
This has been a point of contention for me as well. People that need the drugs the most may or may not get them. In many such trials as you needed there is already enough evidence to know if it is a positive study or not. I think for the patient that is grasping for air this could be mentally devastating. I do however think in some cases there needs to be some control arms, but for patients that are already resistant to hormones or chemo, I think they need all the help we can give them.
Short answer and the bottom line is I totally agree with you Tony.

peace and love
Dale
My PSA at diagnosis was 16.3
age 46 (current)
My gleason score from prostate was 4+5=9 and from the lymph nodes was 4+4=8
I had 44 IMRT's
Casodex
Currently on Lupron
I go to The Cancer Treatment Center of America
Married with two kids
latest PSA 5-27-08 0.11
PSA July 24th, 2008 is 0.04
cancer in 4 of 6 cores
92%
80%
37%
28%
 


Banker
Regular Member


Date Joined Sep 2008
Total Posts : 30
   Posted 11/9/2008 7:10 AM (GMT -6)   
This is a complicated matter. It is important to remember that clinical trials ARE experimental tests first and foremost. They are not treatments. Various arms of the studies are needed to give the best understanding of the drugs. It only makes sense to stop the trials when there is overwhelming information that suggests that no treatment or a specific treatment is not effective and doing harm. In these instances, it would be wrong to continue the trial. I know this is not what folks want to hear. There are calls for the FDA, our federal dept charged with regulating drugs, to relax the rules that require the many trials needed to certify the efficacy of certain drugs. I, for one, don't want this to happen. I want all of the regulations and safegaurds required to bring a drug to market. I want the assurance that when a drug is put on the market that it has been properly vetted and researched. So what does this do for those of us (me too) who have diseases that MIGHT benefit from the experimental drugs. Not much. We have to remember that clinical trials are experiments FIRST.
born 1952
diagnosed with HIV 2001
PSA--ranged from 2-7
2 previous biopsies-all negative 2005 and 2007
diagnosed with prostate cancer:Sept 30, 2008
Gleason Score 3+4=7
bone scan 10-9-08--appears to be negative
trans rectal MRI 10-27-08
appts w/docs to review tests scheduled 11-12-08
 


don826
Veteran Member


Date Joined May 2008
Total Posts : 1010
   Posted 11/9/2008 8:18 PM (GMT -6)   

Hi TC et al,

Tony, you pose a good question. Banker, I agree with your thougtful reply. A controlled study is required to establish the efficacy of a treatment at various stages of a disease as well as safety. I looked at clinical trials when first diagnosed but quickly decided against it for the same reasons as Tony. I did not want to be in the placebo group. There is an allowance for some patients to recieve drugs that are in trial without being a part of the trial. It is called a "compassionate" use. Here is a link that explains it far better than I can.

 
My personal opinion is that in the case of a drug such as Albireterone, that has shown so much promise in stage II trials, is that it should be more widely available to a select group as stated by Dave. It is in stage III now and some reports say it may be available by 2011. Still a ways off for some. The down side is if the drug is not approved or not effective enough to be commercially viable. What then for those who are helped by it? I suppose one could say they are no worse off than before and have had some temporary relief. Truly a dilemma.
 
An adjunct to this question is one of my pet peeves regarding news media reporting of the latest cancer cures. Just this week CBS had one that would utilize specific biological deformities created only in cancer cells to deliver a drug with the ability to discriminate on the basis of the marker and thus attach to and destroy only the cancerous cell. As usual the last line in the report was that the research was experimental but the researchers hope to have a viable treatment within a decade. That may be too late for some of us. I sometime wish they would not publish such preliminary or theoretical research. On the other hand it may do some good in terms of fundraising as people are more prone to donate to a cause that is doing good or making progress.
 
Don
Diagnosed 04/10/08
Age 58
PSA 21.5 (first and only test resulted from follow up visit to emergency room for kidney stone. first time for kidney stone too)
Gleason 4 + 3
DRE palpable tumor on left side
100% of 12 cores positive for PCa range 35% to 85%
Bone scan clear
Chest x ray clear
CT scan shows potential lymph node involvement in pelvic region
Started Casodex on May 2 and stopped on June 1, 2008
Lupron injection on May 15 and every four months for next two years
PSA test on July 14, 08 after 8 weeks hormone .82
Started IMRT/IGRT on July 10, 2008. 45 treatments scheduled
First 25 to be full pelvic for a total dose of 45 Gray to lymph nodes.
Last 20 to prostate only. Total dose to prostate 81 Gray.
Completed IMRT/IGRT 09/11/08.
Second Lupron shot 09/11/08
Next PSA test by oncologist 03/09
 
 


Tony Crispino
Veteran Member


Date Joined Dec 2006
Total Posts : 8128
   Posted 11/9/2008 10:15 PM (GMT -6)   
Thanks all,

First I want to correct the spelling and the correct spelling is Abiraterone. I have fixed the above post in case a new guy sees it and has interest in it.

Very good replies. I mentioned the registry for the do nothing guys as a future control arm that would be used instead of a control arm in every study for a new drug. I am not advocating the removal of such control arms, just that there has to be a better way of having the placebo included. The fact is that thousands of guys go home after all the standard therapies stop working as opposed to trying experimental drugs. It would be great if they had the option of being monitored for the purpose of reducing the placebo requirement.

Tony
Age 46 (44 when Dx)
Pre-op PSA was 19.8
Surgery on Feb 16, 2007 @ The City of Hope
Post-Op Pathology: Gleason 4+3=7, positive margins, Extra Prostatic Extension (EPE)
Bilateral seminal vesicle invasion (SVI); Stage pT3b, N0, Mx
HT began in May, '07 with Lupron and Casodex 50mg (2 Year ADT)
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (September 17 '08): <0.1 ~ Undetectable!
 
You can visit my Journey at:
 
STAY POSITIVE!
 
 

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