UPDATE: The Christopher Reeve Paralysis Act is now listed in Thomas. The House bill number is HR 1554. The Senate bill has not yet appeared in Thomas.
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The last two years have presented us with challenges when it came to getting the CRPA passed. With the passing of Christopher Reeve, a small but important portion of the CRPA was passed as the Research Review Act of 2004.
This year, starting with the rally, we will be trying again. It will be important to know the ins-and-outs of the bill. Since it has yet to be introduced, we can only guess that its contents will be similar to the one introduced last session.
Let's begin with what the Research Review Act of 2004 accomplished: The Director of the NIH was given a mandate to give a report to Congress on how the Roadmap for Medical Research has helped bring medical research into the new century, so-to-speak, with a particular interest in paralysis and spinal cord injury research research. Specifically, has the Roadmap for Medical Research improved multidisciplinary research? Has paralysis research benefited from the research consortia with respect to advancing treatments, developing new therapies, or collaborations on clinical trials?
From the Office of Legislative Policy and Analysis:
Results from the report will likely be used as a basis for determining the viability and potential effectiveness of the CRPA. If we can get a copy of this report [check with Bilirakis's office], it would be enormously helpful.
The CRPA has four parts that consist mostly of building research consortia and ensuring coordination and communication between members of the consortia; these consortia will help reduce or eliminate the unnecessary duplication of research. The first part focuses on enhancing communication between the various NIH agencies when it comes to basic and translational research, while the second does the same across a subset of NIH agencies that focus on rehabilitation and clinical trials. The importance of this second part cannot be overlooked. Setting up a clinical trial network is important for a number of reasons, including the following two that Wise mentioned:
An important thing to note about training a clinical trial network is the standardized neurological examinations Wise mentioned. Specific standards will be drawn up for examining the various aspects of paralysis. There will likely be standard measures of strength, pain, function, and sensation that can be used across all forms of paralysis, ensuring that everyone suffering from paralysis will benefit from the network, from ALS to Guillain-Barre to MS to SCI to TM.
Continuing on, the third section of the CRPA focuses on quality-of-life and care improvements, as well as providing funds for states to add a data collection network relating to paralysis. This section also aims to provide better caregiver education and information on preventing secondary complications, with an additional focus on making our communities more accessible to those with paralysis.
Finally, the fourth section brings the Veteran's Administration into the mix of NIH agencies across the prior three parts. Allowing the VA and the PVA to work hand-in-hand with researchers and rehab therapists will be helpful in testing new therapies, reducing research and clinical trial costs, helping our veterans, and a number of other things that currently escape me.
In summary, the CRPA, as proposed last session, will likely be retrofitted to insert the necessary language to integrate with existing programs like the Roadmap to Medical Research. Doing so would allow the paralysis community to tap into an existing source of funding, thereby reducing the total amount of additional funding required to get it off the ground. With the new era of "fiscal responsibility," the reduced costs will be an attractive option.
To the best of my knowledge, everything except my predictions in the summary are accurate. Possibly not complete, but hopefully sufficient.
-Steven
[This message was edited by Steven Edwards on 04-15-05 at 10:28 AM.]
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The last two years have presented us with challenges when it came to getting the CRPA passed. With the passing of Christopher Reeve, a small but important portion of the CRPA was passed as the Research Review Act of 2004.
This year, starting with the rally, we will be trying again. It will be important to know the ins-and-outs of the bill. Since it has yet to be introduced, we can only guess that its contents will be similar to the one introduced last session.
Let's begin with what the Research Review Act of 2004 accomplished: The Director of the NIH was given a mandate to give a report to Congress on how the Roadmap for Medical Research has helped bring medical research into the new century, so-to-speak, with a particular interest in paralysis and spinal cord injury research research. Specifically, has the Roadmap for Medical Research improved multidisciplinary research? Has paralysis research benefited from the research consortia with respect to advancing treatments, developing new therapies, or collaborations on clinical trials?
From the Office of Legislative Policy and Analysis:
P.L. 108-427, the Research Review Act of 2004, requires the National Institutes of Health (NIH) to submit an NIH Roadmap for Medical Research progress report to Congress. The bill also incorporated a component of an earlier bill, the Christopher Reeve Paralysis Act, requiring NIH to prepare a report describing NIH Roadmap efforts with respect to spinal cord injury and paralysis research.
The Roadmap for Medical Research is not a congressional Act. The Roadmap was conceived in May 2002 by the Director of NIH to identify major opportunities and gaps in biomedical research that the Agency must address in order to make the greatest impact on the progress of medical research. Developed with input from more than 300 nationally recognized leaders in academia, industry, government, and the public, three NIH Roadmap themes emerged: New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise.
Under section 2, subsection (b), the report must be submitted to the House Committee on Energy and Commerce and Senate Committee on Health, Education, Labor and Pensions no later than February 1, 2005.
The Roadmap for Medical Research is not a congressional Act. The Roadmap was conceived in May 2002 by the Director of NIH to identify major opportunities and gaps in biomedical research that the Agency must address in order to make the greatest impact on the progress of medical research. Developed with input from more than 300 nationally recognized leaders in academia, industry, government, and the public, three NIH Roadmap themes emerged: New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise.
Under section 2, subsection (b), the report must be submitted to the House Committee on Energy and Commerce and Senate Committee on Health, Education, Labor and Pensions no later than February 1, 2005.
The CRPA has four parts that consist mostly of building research consortia and ensuring coordination and communication between members of the consortia; these consortia will help reduce or eliminate the unnecessary duplication of research. The first part focuses on enhancing communication between the various NIH agencies when it comes to basic and translational research, while the second does the same across a subset of NIH agencies that focus on rehabilitation and clinical trials. The importance of this second part cannot be overlooked. Setting up a clinical trial network is important for a number of reasons, including the following two that Wise mentioned:
Standardizing neurological examinations. Over the coming 6 months, we have to make sure that the participating centers are able to carry out standardized neurological examinations. This is no small task and it must be a continuing effort. Every 6 months, we will be re-training and re-testing clinicians in the centers, to make sure that they carry out the examinations reliably. I am sure that some of the investigators participating in the workshop are thinking to themselves that this is not going to be as easy as they thought.
Treatments. This is our next big task, to identify therapies that can be reliably produced and consistent across centers. For example, there is currently no adequate source of cells for transplantation across centers. A few of the centers are producing cells of their own from fetal or adult sources. Many of the centers don't have that capability and we must find some way of ensuring a high-quality and consistent source of cells. There will be much work ahead to make sure that the therapies that we would like to test are ready for human clinical trial.
Treatments. This is our next big task, to identify therapies that can be reliably produced and consistent across centers. For example, there is currently no adequate source of cells for transplantation across centers. A few of the centers are producing cells of their own from fetal or adult sources. Many of the centers don't have that capability and we must find some way of ensuring a high-quality and consistent source of cells. There will be much work ahead to make sure that the therapies that we would like to test are ready for human clinical trial.
Continuing on, the third section of the CRPA focuses on quality-of-life and care improvements, as well as providing funds for states to add a data collection network relating to paralysis. This section also aims to provide better caregiver education and information on preventing secondary complications, with an additional focus on making our communities more accessible to those with paralysis.
Finally, the fourth section brings the Veteran's Administration into the mix of NIH agencies across the prior three parts. Allowing the VA and the PVA to work hand-in-hand with researchers and rehab therapists will be helpful in testing new therapies, reducing research and clinical trial costs, helping our veterans, and a number of other things that currently escape me.
In summary, the CRPA, as proposed last session, will likely be retrofitted to insert the necessary language to integrate with existing programs like the Roadmap to Medical Research. Doing so would allow the paralysis community to tap into an existing source of funding, thereby reducing the total amount of additional funding required to get it off the ground. With the new era of "fiscal responsibility," the reduced costs will be an attractive option.
To the best of my knowledge, everything except my predictions in the summary are accurate. Possibly not complete, but hopefully sufficient.
-Steven
[This message was edited by Steven Edwards on 04-15-05 at 10:28 AM.]
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