What should clincial trials involve.

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English Alf
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Date Joined Oct 2009
Total Posts : 2218
   Posted 2/19/2011 6:18 AM (GMT -6)   
Hello all,

Just a few observations and thoughts about Clinical trials seeing how complciated they can be.(I can’t remember a great deal, but, over 30 years ago, while at university, I did spend about sixth months studying the use of trials relating to human behaviour)

What do you need for a trial? A lot, but I'll cover what for me is the most relevant at present.

You have to find a group of people who are suffering from the problem who are prepared to risk trying out the new treatment/drug/procedure. But you also need a placebo group, so you have to find people who despite being ill are also prepared to take part in a trial where they will not actually know if they are or are not receiving the new “thing”.

You also have to have a control group, who you don’t treat. So you have to find people who are ill who are prepared not to receive the new "thing".
(You might even include a group who are not ill to see what effect the "thing" has on them.)

All the people in the trial groups can only stay in the trial if they do not receive any treatment that might mask the effect or lack of effect of the trial. You thus have to start with a bigger sized group than you need as people in the trial are bound to drop out.

And clearly you have to have a group that is large enough for the results to be statistically meaningful.

That is an over simplification, but what about Prostate Cancer trials.

Testing relating to PCa has to cover a wide spectrum of patients, it is not like a new procedure to treat say broken fingers where there might be very little relevant variation in the subjects involved.

The people selected for a PCa-related trial have to represent the people who suffer from PCa. So the trial has to cover the full age range, the range of PSA levels, Gleason scores and staging. It also needs to cover the range of treatments and may thus need to test guys doing AS, surgery, RT, HT etc, and the various combinations of those treatments. It also need to cover the variation in people’s lifestyles, general health etc. And with PCa even ethnicity and family history are relevant. (You don’t, for instance, want a trial where the volunteers are all people who have been motivated to volunteer because their father’s all died of PCa.) You thus also need to have a large enough group to ensure that the size of each sub-group is statisically meaningful too.

So if I take my own case, it is no good to me knowing that a trial only tested something on say 10 men aged 75 with Gleason 6 who only had RT, who had T1 staging and whose PSA was never been higher than 5. There are a couple at HW, but there are in fact very few men who, like me/us, have Gleason7 and T3b before the age of 50, so there are thus also going to be very few people similar to me who have taken part in trials, so there is going to be a shortage of any data that might be meaningful to my specific situation.

Too much analysis for a Saturday morning perhaps.

(Edited - see my follow up comment in a post below. The above is was to try and describe my idea of what/who an ideal trial should include rather than what it might actually include)
Born Jun ‘60
Apr 09 PSA 8.6
DRE neg
Biop 2 of 12 pos
Gleason 3+3
29 Jul 09 DaVinci AVL-NKI Amsterdam
6 Aug 09 Cath out
PostOp Gleason 3+4 Bladder neck & Left SVI -T3b
No perin’l No vasc invasion Clear margins
Dry at night
21 Sep 09 No pads daytime
17 Nov 09 PSA 0.1
17 Mar 10 PSA 0.4 sent to RT
13 Apr CT
66Gy 28 Apr to 11 Jun 10
Tired + weird BMs
14 Sep 10 PSA <0.1
12 Jan 11 PSA <0.1
Erection OK

Post Edited (English Alf) : 2/19/2011 5:29:33 AM (GMT-7)

Steve n Dallas
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Date Joined Mar 2008
Total Posts : 4848
   Posted 2/19/2011 6:52 AM (GMT -6)   
"It also needs to cover the range of treatments and may thus need to test guys doing AS, surgery, RT, HT etc, and the various combinations of those treatments."
Nope - thats not true... along with some of your other comments. Trials are generally much more specific then what you've outlined.

English Alf
Veteran Member

Date Joined Oct 2009
Total Posts : 2218
   Posted 2/19/2011 7:25 AM (GMT -6)   
Steve. I said I'd simplified what I was getting at and I may have turned it back on itself so I messed up my argument. I thought that what I was getting at is sort of exactly your point, ie that trials are often too specific and don't cover the full range! hence they may not be of much use to people who differ from the subjects tested.

I thought that in calling the thread "what should clinical trials contain" rather than "what do clinical trials contain" I had covered it.

I was trying to describe an ideal all-encompassing test, and should also perhaps have included the thought that a worthwhile test would also take place over a number of years.


Post Edited (English Alf) : 2/19/2011 7:11:27 AM (GMT-7)

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