Clinical Trial Time Table

[manouli]

I could not watch the video, can you guys check this video to see what good information they are telling us. Thanks,manouli


Regeneration potential of the adult stem cell
By Philip J. Horner, PhD
Assistant Professor, Department of Neurosurgery
University of Washington

April 11, 2006



Northwest Regional Spinal Cord Injury System (NWRSCIS
This was an SCI Forum presentation of the Northwest Regional SCI System, Department of Rehabilitation Medicine, University of Washington.

This presentation was video recorded and may be viewed as streaming video on your computer using Windows Media Player or Quicktime.


http://depts.washington.edu/rehab/sci/repairing.html

[Scott Buxton]

Yay! Thank you for the cautious realism and HOPE! Scott.

[Keith]

So I guess what you're trying to say in a polite way it's still going to be a long time.? Before anybody gets out of these wheelchairs.

[antiquity]

Safety. Benefit must balance risk. A treatment that is risky, however, usually requires more proof of efficacy and can only be applied to diseases and conditions that are high risk. Correspondingly, a very safe treatment (such as eating an aspirin a day, can sometimes be taken to clinical trial without a great deal of efficacy information.

Some of the treatments being considered utilize drugs that are already approved for other conditions. This will eliminate the need for a phase 1 trial allowing the treatment to go right into phase 2 efficacy testing. Also, some labs are beyond the basic research stage and are ready to enter the human trials arena. If we only consider these, I think the period from start to FDA approval would be shorter. I don't think we'll be waiting another 11 years.

[NWC4]

Originally Posted by antiquity

Some of the treatments being considered utilize drugs that are already approved for other conditions. This will eliminate the need for a phase 1 trial allowing the treatment to go right into phase 2 efficacy testing. Also, some labs are beyond the basic research stage and are ready to enter the human trials arena. If we only consider these, I think the period from start to FDA approval would be shorter. I don't think we'll be waiting another 11 years.

Dr Young,

If the above statement is correct, why the need for a Phase I lithium trial in China? Can you explain when a Phase I trial is necessary for a drug approved for other conditions?

[Wise Young]

Originally Posted by NWC4

Dr Young,

If the above statement is correct, why the need for a Phase I lithium trial in China? Can you explain when a Phase I trial is necessary for a drug approved for other conditions?

NWC4, a phase 1 is probably not necessary for the regulatory agency. We discussed it and realized that we don't know very much about giving lithium to people with chronic spinal cord injury. I don't know of any study of lithium effects on people with spinal cord injury. Does it increase neuropathic pain? Does it change their appetite? Can they tell when they are on the drug (which might break our blind), and other questions have not been answered. We are also measuring lithium levels in the serum, to find out if the standard doses that are given to other people would be suitable for people with chronic spinal cord injury.

Wise.

[Tufelhunden]

Originally Posted by Schmeky

It the USA, if a sure-fire cure for SCI was discovered today, it would still be 15 - 20 years to secure funding, set up a network of clinical trials, complete all three clinical trial phases (successfully that is), then gear up for real world applications to humans. This is how the system works.

I always had a feeling in my gut that it would be about this long.

[Schmeky]

My clinical trial information came from a Miami Project Newsletter. It shook me up. Big time. As I researched more, I realized that lab discoveries, related clinical time trials, and application to humans, can easily take a generation, if not longer.

Many of us that are working towards a cure, are working for the next generation.

I wonder who will supercede Dr. Young? There is the very real chance he will not see widescale application of effective therapies to chronic SCI's in his lifetime.

[Tufelhunden]

Originally Posted by Schmeky

I wonder who will supercede Dr. Young? There is the very real chance he will not see widescale application of effective therapies to chronic SCI's in his lifetime.

Unfortunately, with all of the negative feedback from the Federal Government regarding Embryonic Stem Cell Research, there is still this "stigma" attached with this whole field. This has had the negative impact of steering a lot of young newly emerging medical talent away from this specialty and into more "acceptable" fields of medicine.

[Wise Young]

Originally Posted by Schmeky

My clinical trial information came from a Miami Project Newsletter. It shook me up. Big time. As I researched more, I realized that lab discoveries, related clinical time trials, and application to humans, can easily take a generation, if not longer.

Many of us that are working towards a cure, are working for the next generation.

I wonder who will supercede Dr. Young? There is the very real chance he will not see widescale application of effective therapies to chronic SCI's in his lifetime.

Schmeky, please. Others have done it and are doing it. Why can't we? I have heard every excuse there is, including the suggestion that we are too few and too poor, that it is too difficult for people with spinal cord injury to travel and lobby Congress, that Congress and the people of the United States do not care, that the FDA is against us, that industry is against the cure, and on and on. There are thousands of clinical trials going on in the United States. Treatments are being approved all the time by the FDA. I think that Congress and people do care. We have really only started to lobby the government and raise our voices for clinical trials.

Wise.