Tupelo3,

You make a good point "we live in the world of the FDA and EMA". You go on to argue that "we have no choice but to follow the rules". You may be right. My wish is to change the rules.

In my opinion, PD research and treatment can be done more efficiently and more effectively by making better use of technology. As I see it, if there was the will, all PwP could, using electronics, have their symptoms monitored continuously, the data sent to their doctors and an anonymized version placed on a database open to all to research. In such a world, much of the distinction between treatment and research breaks down.

On a specific point, you write:

"However, where we disagree is that I believe that a properly designed and controlled cllinical trial is more likely to provide us with useable information about the efficacy of a drug than your suggestion of three month uncontrolled individual studies."

I actually wrote:

"I find it difficult to understand why a trial should take 3 years. What extra information will the last two years give? I've posted previously on high frequency testing - measuring 24/7 rather than every 3 months, say."

The 3 month figure is used as an example of bad practice, not good. To some extent, there is an equivalence in the power of a trial between the frequency of the observations and/or the number of participants and/or the duration of the trial.

The individual studies should last as long as they are benefitting the patient: constantly collecting data and using it to assess whether the treatment is working and should be continued. To enable the sharing of data, I see the need for each individual study to follow a common protocol. This provides control, but it should only be followed to the extent that it is in the interests of the patient.

John