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Old 11-13-2014, 01:01 PM
johnt johnt is offline
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Join Date: Apr 2009
Location: Stafford, UK
Posts: 1,059
15 yr Member
johnt johnt is offline
Senior Member
 
Join Date: Apr 2009
Location: Stafford, UK
Posts: 1,059
15 yr Member
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We need to speed up the clinical trial process. So, improved trial design is to be welcomed. However, I'm not so sure that the focus on negating the impact of the placebo effect is the best way forward.

At the end of the day, every medical intervention delivers both organic and social/psychological effects that feed back with each other. Therefore, every therapy has a placebo component. Probably, many placebos have an unexpected truly efficacious effect; for instance, the act of giving data may lead to you taking better care of yourself in general.

My feeling is that we would benefit more from increasing the frequency of testing. To see why, consider two measurement strategies:
A, test at the beginning of the trial and at the end of a year, say. Suppose, by way of an example, A shows a 12% improvement
B, test every month. B shows a non-compounded 1% improvement each month.
Although both methods have the same final outcome, method B has more statistical power. With modern technology we can test every second of every day.

Increasing the frequency of testing also prepares the ground for the focus of the trial to be on the individual, rather than the cohort. The question to be answered is no longer whether therapy X works, but whether it works for me. If you were person B, above, would you want any more convincing that the treatment was right for you, even if everyone else's outcome was poor; perhaps you have a different type of PD.

Finally, this data driven approach lends itself to continuous testing. Testing is not limited to the trial, it continues indefinitely.

John
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Born 1955. Diagnosed PD 2005.
Meds 2010-Nov 2016: Stalevo(75 mg) x 4, ropinirole xl 16 mg, rasagiline 1 mg
Current meds: Stalevo(75 mg) x 5, ropinirole xl 8 mg, rasagiline 1 mg
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