Deans' stroke musings: Final rules aim to make more clinical trial information available to the public

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.

Saturday, September 17, 2016

Final rules aim to make more clinical trial information available to the public

And with this your doctor has no excuse for not keeping up-to-date on clinical research. They could outsource summarization to third parties.
http://www.mdlinx.com/internal-medicine/washington-report/2016/09/16/6865901?
In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services (HHS) today issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration (FDA)–regulated drug, biological, and device products.
At the same time, the National Institutes of Health (NIH) has issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH–funded trials, including those not subject to the final rule.
“Access to more information about clinical trials is good for patients, the public, and science,” said NIH Director Francis S. Collins, MD, PhD. “The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”
Clinical trials are vital to medical advances because they test new and existing health–related interventions, helping us understand whether they are safe and effective in humans when used as intended. Some clinical trials provide information about which medical treatments work best for certain illnesses or certain groups of people, the HHS noted.
Expanding the registration information in ClinicalTrials.gov should improve people’s ability to find clinical trials in which they may be able to participate and access investigational therapies. More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study, and improve study designs, ultimately advancing the development of clinical interventions.
Requirements under the final rule apply to most interventional studies of drug, biological, and device products that are regulated by the FDA. The requirements do not apply to phase 1 trials of drug and biological products, or small feasibility studies of device products. The final rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not dictate how clinical trials should be designed or conducted, or what data must be collected.
“When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future, and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers,” said FDA Commissioner Robert M. Califf, MD. “The FDA will help ensure compliance with these new requirements so that patients and providers can have confidence in, and access to, significantly more clinical trial information, and researchers can improve clinical trial focus and design.”
The final rule was informed by nearly 900 comments received during the public comment period on the Notice of Proposed Rulemaking, as well as the National Library of Medicine's many years of experience with managing and operating ClinicalTrials.gov. Important elements of the final rule include:

Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information.
Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA–regulated products that have not yet been approved, licensed, or cleared by the FDA.
Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol.
Requiring additional types of adverse event information.
Providing a list of potential legal consequences for non–compliance.