Great post! Thanks a lot.....

2009-05-13T00:21:00.000-07:00

I have commented on the study design of a similar ...

2009-03-12T20:47:00.000-07:00

I have commented on the study design of a similar gene therapy treatment, cere 120, that recently reported "failure to meet primary endpoints" on the Alzheimer's Research Forum. Also my colleagues in the Parkinson Pipeline Project have analyzed the past failures of placebo brain surgery controlled trials in light of the research literature on placebo effects in a poster presentation at the annual meeting of ASENT. We have previously questioned the ethics of sham surgery,in a scientific journal article, Neurotherapeutics vol 4, but the current situation adds injury to insult, by introducing type 2 false negative bias from underestimating the power of placebo brain surgery.

We have concluded that the strength of placebo effect from sham brain surgery, is likely to be masking any benefits of the treatment, and that alternate designs are advisable, such as randomized comparison to best medical treatment, as was done in the recently published DBS study.

Readers should also be aware that the FDA has Patient Consultants for PD, who are quite knowledgeable about clinical trial design, who can be requested to attend sponsor meetings for review of any scientific question. These consultants can help enlighten regulators as well as sponsors about how to avoid making the same mistakes repeatedly.

Also preliminary discussions with the Chair of the NIH-RAC indicates that the findings reported here will be the subject of thorough analysis of these design flaws.

We hope the realization of this bias will dampen expectations to reduce its impact.

For more information visit www.pdpipeline.org

Comments on Parkinson's Med: Neurologix Commences its Phase 2 Clinical Trial of...

Great post! Thanks a lot.....

I have commented on the study design of a similar ...