Print

Please login or register.
1 Hour 1 Day 1 Week 1 Month Forever
Login with username, password and session length

[CLKD]

Did anyone watch the two programmes about trialling a Drug; so disappointing that those with apparent improvement wasn't enough % to continue trialling the drug. Pfizer stepped in for a while but decided to close it's Research Dept. completely. 

I have never believed that the plaecbo effect for myself though I am aware that for many it can ease symptoms.  I can't believe that the improvements that some on the Trial had when the actual Drug was prescribed after the 1st 9 months, when some were on a placebo ;  I was so disappointed.  The programme followed 9 I think  out of the 44 on the Trial which over-all isn't a large number; but it was a double blind test so protocols were followed.

I really hope that someone will look into how the Drug improved issues and take it up again. 

[Shadyglade]

Probably not enough money in it. That's the bottom line for the drug companies.

[Hurdity]

I didn't watch the first one but I watched the second one last night and it was very interesting and moving especially to see the dramatic improvements in some of the patients.

As far as I remember there were something like 41 participants altogether on the trial - including the initial placebo group, as well as the treatment group.

The reason for lack of statistical significance in the outcomes measured was due to the very small sample (ie number of trial participants) combined with the short trial time. Because the intervention was so invasive (drilling holes in the skull and inserting a metal portal for the drug), the trial size was probably as large as it could feasibly be. Also for such a major condition (Parkinson's) that takes years to develop, 9 months was far too short a time to have such a dramatic difference in such a small sample. The treatment group showed a 5 % (I think) improvement in the 9 months and if the drug were effective you would expect this percentage to increase after some (an unknown period of) time and eventually reach statistical significance. However the research team felt it was unethical for the placebo group to continue without treatment at all when there was some hope of improvement hence both groups receving the drug after 9 months and for the following 9 months.

I felt it was an unrealistic demand by Pfizer, to make their future funding contigent on acheiving a statistically significant improvement in the 9 months.

Also one of the participants who was a very severe case and who was on the drug supposedly, wasn't actually getting any due to the severity of his condition so if his data were included that would reduce the significance for a start.

However there were a huge amount of other data collected which as far as I understand showed considerable promise for the drug and I think there is hope that another drugs company will take up the challenge and extend the trial. The company was mentioned on the programme but can't remember which one it was. I haven't looked at the info on this website but anyone who is interested might want to read about it here:
https://www.parkinsons.org.uk/research/clinical-trial-gdnf

Hurdity x