Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Wednesday, November 19, 2014

Success or failure, feds want trial results posted online

This is so necessary, With 1000+ trials of neuroprotective drugs that worked in rodents but failed in humans, it would probably make solving that problem much faster and cheaper than waiting for 1000 clinical trials to fail.
http://www.fiercebiotech.com/story/success-or-failure-feds-want-trial-results-posted-online/2014-11-19
Federal regulators are proposing a rule that would require makers of drugs and medical devices to publicize the results of thousands of clinical trials, regardless of whether they succeed, part of a global move toward transparency in R&D.
The proposal, developed by the Department of Health and Human Services and the National Institutes of Health (NIH), would require the makers of unapproved drugs and devices to post summaries of study results on ClinicalTrials.gov, the government's public portal, within a year of trial conclusion. As it stands, sponsors are required to disclose results only on studies of approved products, which account for about 15,000 of the roughly 178,000 trials posted on the site, according to NIH.
The new rules, if adopted, would generally exclude Phase I and feasibility trials, NIH said, and they wouldn't alter the trial-design requirements needed to win FDA approval. Instead, they would greatly expand the public pool of clinical results, preventing unnecessary duplication, weeding out unsafe or ineffective products, and informing future research, according to NIH.

"Medical advances would not be possible without participants in clinical trials," Director Francis Collins said in a statement. "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld."
The proposed changes would also streamline the rules for just who is required to submit trial information; expand the amount of information that must be disclosed shortly after study startup; and force sponsors to update their ClinicalTrials.gov entries more regularly.
HHS and NIH are soliciting feedback on the proposal from industry and academia through Regulations.gov, opening up a 90-day window for discussion before making a final decision on the new rules.
Meanwhile, some of the world's largest drug developers have capitulated to the prodding of global regulators, making varying amounts of data available through ClinicalStudyDataRequest.com. Some, like Sanofi ($SNY) and Bayer, are disclosing only the results on newly approved products, while others, including GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ), have agreed to hand over huge swaths of anonymized data in the interest of global R&D.
- read the release
- get more from NIH

No comments:

Post a Comment