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Old 10-25-2013, 02:09 PM
Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
Tupelo3 Tupelo3 is offline
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Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
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John, some of your points were addressed at the PD Therapeutics Conference yesterday:

1.- Run the trial as much for the convenience of the PwP as for the staff. This issue came up several times. I spent about 30 minutes with the MJFF research team speaking about it also. I think everyone is in agreement that its an important issue and are trying to come up with workable solutions. Because so much of the study is specific to a lab or clinic, its convenience is not always easy.

2. - To some extent the number of people wishing to enter a trial reflects people's perception of the promise of the therapy. Low uptake is in a sense a vote of no confidence; this may be unfair, especially to early life-cycle trials, but it could reflect poor communication or low relevance.
No doubt about it. We spoke about getting doctors more involved in the process to help explain the studies and guide their patients to appropriate trials. I am going to be discussing this more with the team at MJFF.

3. - Do as much of the testing at home as possible.

It interesting that you mention this. First, several of the researchers, as well as MJFF, are working on PD phone apps for continuous symptom measurement. The issue of home testing for studies came up and there was a debate. Some, like you, thought it was a great idea. Others felt there was too much lack of control and the chance for getting bad data (e.g. you may not know for sure who actually had the phone and produced the data). There was also the general feeling that the FDA would have serious problems with the concept for actual drug approval.

4. - Find alternatives to having some patients taking a placebo. (It's not perfect, but in many situations placebo figures can be shared between trials.)First, let me state that every clinical study presented showed huge placebo effects when tested. It remains a big problem and must be controlled for. Some of the thoughts involved better imaging techniques for determining trial success which would be immune to a placebo effect.
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