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My job is to enable many students at my school research view that they would never have seen had they not had experience in my lab and presentations at conferences.
the future of science in this country depends on NCRR IDEA program. Young people need to have hands-on experience that allows them to see that science is a great career choice. Without NCRR IDEA program, new pipes and enthusiastic young people will dry up and our country will lag far behind in the world.
In response to prospective changes within the NIH and their potential ramifications for NCRR, I forward the following response from Elizabeth Blackburn, Noble Laureate, 2009.
To whom it may concern:
I am writing to urge the continued support of the Tetrahymena stock center, which is currently administered by NCRR. I feel that this stock center has considerable and continuing scientific value. While Tetrahymena can be thought of as a protozoan model organism, such biological systems are in fact very important for translational research. I speak from direct experience, as my and my lab’s research, that was originally done on Tetrahymena telomeres and telomerase, has had major implications for translational work. Furthermore, in current developments in many other research labs, Tetrahymena is emerging as a major system in which membrane proteins can be expressed for vaccine production (such proteins are difficult to express in other systems), and enzymes for biofuel production are also successfully expressed in this inexpensive, easy-to-grow organism. The strains of Tetrahymena, both those existing now and those that will be produced in the course of this and other new work, constitute a uniquely valuable and, indeed, irreplaceable resource. This resource will require the continued existence of a centralized stock center for the storage and distribution of these stocks.
I urge you to make every possible effort to ensure that the proposed reorganization at NIH does not jeopardize the Tetrahymena stock center – it is a critical resource.
Thank you for this opportunity to communicate my concerns, and to convey my support for the continued existence and functioning of the Tetrahymena stock center.
Elizabeth H. Blackburn
2009 Nobel Laureate in Physiology or Medicine
Dear Drs. Collins, Tabak and Committee Members:
As a fortunate recipient of NCRR funds and an NIH-funded clinical investigator, I am writing with respect to the proposed National Center for Advancing Translational Research, and specifically about potentially unintended ramifications regarding the re-structuring of NCRR. I currently serve as the PI of an IDeA program Center of Biomedical Research Excellence (COBRE) and have also received shared equipment grants and construction grants in the past. As such, my research program has benefitted from P20, P30, C06 and S10 grants funded by NCRR. I also lead investigator initiated, patient-oriented U19, P30, and R01-type awards from NIAID and NIAMS. I wish to advocate for keeping the IdEA and RCMI programs, as well as construction and shared equipment grants within an intact, vibrant NCRR.
As outlined by the external Process Evaluation of the COBRE program conducted by Carlyn Consulting in September 2008, the COBRE program has been extremely successful in “achieving the process goals of the program and in developing junior investigators who received significant support in launching NIH-funded independent research programs”. Indeed, when COBRE investigators were compared to K22 recipients (who were at research-intensive institutions primarily not in COBRE states), the COBRE investigators had similar success in garnering future funding but even better publication records than the K22 recipients. Many other examples are outlined in this document, like over 80% of COBRE investigators having outstanding scientific success and nearly 80% having received tenure track positions within the first 3 years of COBRE funding. I would refer the committee to this external evaluation for additional data. Therefore, the COBRE program in its current home of the NCRR has been quite successful in launching the independent research careers of junior investigators (usually at ages younger than the national average), and, as such, would greatly benefit from remaining within an intact NCRR.
As a more personal example, COBRE investigators from the Oklahoma Medical Research Foundation have received to date 24 R01 awards, 7 R21 awards, 4 R03 awards, 2 K awards and 55 other national NIH or foundation awards. This has resulted in over $50M in external funding for the scientific questions of a strong cadre of junior investigators. These initial COBRE investments have successfully launched many independent research careers just from this one institutional example. Of course, many, many others from additional IDeA states also exist. In addition, competitive ARRA supplements, construction awards and shared equipment grants have also been instrumental in building infrastructure to support patient-oriented research activities in US populations underserved by historical clinical research, including rural and tribal communities.
Therefore, in my opinion, moving the programs currently within NCRR would risk harming what has been a program that has achieved outstanding success and recognition. While in no way detracting from the other institutes who might “inherit” these programs, many investigators fear that not having our historical “home” that understands and has grown these programs for over a decade will be detrimental to the continued success of these programs.
I am hopeful that the committee will understand the crucial need for the NCRR to continue to serve as the supportive home for the IDeA, RCMI, construction and shared equipment programs and will leave the talented NCRR program staff in place to continue and expand on our collaborative historical success.
Sincerely,
Judith James, MD, PhD
Member and Head, Arthritis and Clinical Immunology
Lou Kerr Chair in Biomedical Research
Oklahoma Medical Research Foundation
George Lynn Cross Research Professor of Medicine
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma 73104
Dear Dr. Collins,
I am writing as PI of the joint University of Texas Health Science Center-Houston (UTHSC-H)—University of Texas M. D. Anderson Cancer Center (UTMDACC) Clinical and Translational Science Award (CTSA) to express both my support for the formation of the National Center for Advancing Translational Science (NCATS) and my concerns about the future of the CTSA program in NCATS. Like the other CTSA PIs, I believe that NCATS will make a fine home for the new Cures Acceleration Network, the Molecular Libraries Program, the Therapeutics for Rare and Neglected Diseases program, and the Rapid Access to Interventional Development program, bringing together these related drug-discovery programs into a focused synergy that will help our investigators and the patients we serve. The CTSAs have many features that will both support and benefit from the endeavors of the other programs in NCATS. I believe that, despite the cuts in CTSA funding, most CTSAs have found or will find ways to further support new drug discovery, because we recognize its importance in our mission to improve the health of the American people. Our CTSA-funded Center for Clinical and Translational Sciences has ongoing and expanding drug-discovery programs, and we look forward to working with NCATS.
However, I am concerned about the fate of valuable aspects of the CTSAs that are not in direct alignment with NCATS’ drug-discovery mission. The most pressing of these are our education and community engagement programs. These were deemed required elements of all CTSA programs in the first renewal RFA, despite substantial reductions in CTSA funding. Focused training of the investigators of the future in the new field of translational research is essential for rapid improvement of all aspects of medicine, including but not limited to drug discovery. I hope that CTSA funding and support for KL2 programs will continue and that the programs will not be focused on any one aspect of translation but will continue to produce broadly trained investigators with the knowledge to translate discoveries in a wide range of fields. Our CTSA community engagement programs, which involve bidirectional communication between the public and academia on a wide range of health issues in addition to drug discovery, are also not an obvious addition to NCATS but have had wide-ranging successes and join the public to our research. I cannot strongly enough express my wish that the CTSAs retain in toto the community engagement programs, which are our final step in the translation process and our link with our community partners in healthcare research.
I would also like to express my appreciation for the help of the NCRR administration and staff. Our close and productive collaboration with them on both our Houston CTSA and the projects of the national program has embodied the idea of a cooperative agreement. These individuals are experts in the extremely complicated CTSA program, and I hope that they are allowed to continue administering the program after it is moved to NCATS. Appointing a new staff would set our local CTSAs and the national program back.
In conclusion, I thank you for the opportunity to express my thoughts and also my support for NCATS and the CTSA program.
Sincerely,
David D. McPherson, MD
Professor and Chair, Department of Internal Medicine
The University of Texas Health Science Center at Houston
Director, Texas Heart and Vascular Center
Executive Director, Center for Clinical and Translational Sciences (CTSA UL1 RR024148, KL2 RR012149, and TL1 RR024147)
On behalf of the Howard University RCMI Program, we appreciate the opportunity to provide comments and feedback on this important structural change at the NIH. As a program that focuses on studying specific diseases that disproportionately affect minorities and disadvantaged populations, this has allowed Howard university investigators to make important contributions to the national biomedical research effort. For example, the National Human Genome Center at Howard (NHGC@HU) grew out of a RCMI supported activity. The NHGC@HU has played a pivotal role in better understanding the role of genetics in diseases which disproportionately impact minorities. It should be recognized the RCMI and IDeA programs which were developed and are currently administered by the NCRR share synergistic productivity in the focus on health disparities. These programs accomplish two objectives of national significance:
1. They are heavily focused on health disparities and the improvement of the health and well-being of the nation’s minority and disadvantaged populations.
2. They engage the nation’s workforce of minority investigators and minority institutions in this vital national effort.
These programs collectively insure that America will not be without the input and contribution of its minority scientists and investigators in the quest for better health care for all of its citizens. These programs recognize that significant contributions and excellence does not always come from the top few percentages of research institutions; but, excellence can be found in those institutions that are easily overlooked. The contributions of investigators from RCMI and IDeA institutions are needed in the national biomedical/translational/clinical research effort. The problems we face are too great and the stakes to our nation’s health outlook far reaching to jeopardize the contribution of this cadre of investigators. These programs insure that the nation will have the best thinking of all its citizens in the struggle to solve complex biomedical and health problems. These programs are as essential to the nation as they are to the RCMI and IDeA institutions. Therefore, as NCRR is dismantled to make room for the new NCATS, it is vital that these two programs (RCMI and IDeA) be maintained in their entirety and in such a manner that they can continue their synergistic impact on biomedical/translational/clinical research in America. Therefore, if and when these programs are relocated from NCRR to another IC, it is recommended that they be moved together in total to the other IC. It would be difficult for the success of these programs to continue at their current level if their various components are broken up and distributed across several different IC units.
We write as principal investigators and representatives of the French research community using the nematode worm C. elegans as a model organism. Our work benefits enormously from the expertise and resources offered by the Caenorhabditis Genetics Centre (CGC). The CGC is currently supported by the NCRR. Any loss of support at the CGC will have a direct impact on our projects. In a recent editorial entitled “Model Organisms and Human Health” published in the journal Science, Bruce Alberts wrote, “As incredible as it seems, future research on flies and worms will quite often provide the shortest and most efficient path to curing human disease”. Translational medicine needs new biological insights, gained in part from the use of C. elegans, and that research requires the maintenance of the CGC.
Hugo Aguilaniu, Ph.D.
Ecole Normale Superieure de Lyon
LBMC-UMR5239I
46, Allee d’Italie
69364 Lyon
Jean-Louis Bessereau, M. D., Ph. D.
Genetique et Neurobiologie de C. elegans.
Inserm U789
Ecole Normale Superieure.
46, rue d’Ulm
75 005 Paris
Eric Chevet, Ph.D.
Inserm U889
Université Bordeaux 2
146 Leo Saignat St
33076 Bordeaux
Gwenaelle Collod-Béroud, Ph.D.
INSERM U827,
Institut Universitaire de Recherche Clinique,
641 av du Doyen Gaston Giraud
34093 Montpellier cedex 05
Denis Dupuy, PhD
Institut Europeen de Chimie et Biologie (Bordeaux)
Inserm U869
2, rue Robert Escarpit,
33607 Pessac
Jonathan Ewbank, Ph.D.
CIML
Case 906
13288 Marseille
Marie-Anne Félix, Ph.D.
Institut Jacques Monod
15 rue Hélène Brion
75205 Paris Cedex 13, France
Pr. Simon Galas, Ph.D.
University of Montpellier 1
Faculte de Pharmacie
Montpellier
Vincent Galy, Ph.D.
UMR CNRS 7622, Biologie du Développement, Case 24
Université Pierre et Marie Curie
9 quai Saint-Bernard,
75252 Paris
Pr. Kathrin Gieseler
Université Claude Bernard – Lyon I
Centre de Génétique Moléculaire et Cellulaire – CNRS UMR 5534
16, rue Dubois
69622 Villeurbanne cedex
Sophie Jarriault, Ph.D.
IGBMC
1 rue Laurent Fries, BP 10142
67404 Illkirch
Michel Labouesse, Ph.D.
IGBMC
1 rue Laurent Fries, BP 10142
67404 Illkirch
Renaud Legouis, Ph.D.
CNRS- CGM bat. 26
Avenue de La Terrasse
91198 GIF sur Yvette Cedex
Ivan Matic, Ph.D.
U1001 INSERM
Université Paris Descartes
156 Rue de Vaugirard
75730 Paris Cedex 15
Grégoire Michaux, Ph.D.
IGDR – UMR 6061
2 avenue du Professeur Léon Bernard
CS 34317
35043 Rennes Cedex
Francesca Palladino, Ph.D.
UMR5239/LBMC
Ecole Normale Supérieure de Lyon
46 allée d’Italie
69007 Lyon
Dear Dr Collins and members of the committee,
As a young group leader implementing a interdisciplinary approach of cell division in C elegans including image processing and therefore a technology part, I am very sensitive to the goal of developing translational sciences through NCATS. However, I am deeply concerned about the possibility that such an initiative will result in the death of CGC (or costs that prevent labs to buy lines easily).
The CGC is to my mind, a cornerstone of the scientific approaches based on C elegans. Indeed, such an organism by its amazing simplicity combined to many features making it relevant to human biology and thus a decent model organism, has still a lot to do to foster basic research in biology, biophysics or systems biology. In turn, basic research provides the necessary knowledge to ensure the success of the “translational science” venture.
For example, reproducibility of the results in many labs is essential to validate results ; such a validation get low rewards in term of publication and thus can only be achieved at low cost; a fast and affordable way to get the lines created by other researchers is thus essential in this process. This validation also pave the way to assess possibility of and build novel research on previous results. For these reasons and many others, not mentioned here for sake of brevity, I urge you to keep on supporting the CGC.
Thank you for considering these concerns about CGC.
Best regards
Dear Drs. Collins and Tabak:
I am writing in regard to the proposed National Center for Advancing Translational Research, and specifically rabout its implications for a possible re-structuring of NCRR. I am a researcher and co-director of the Culture and Intervention Core at the Center for Alaska Native Health Research at the University of Alaska Fairbanks, which is currently funded through NCRR COBRE, an IDeA program. I want to emphasize here the importance of IDeA programs to Alaska. I wish to advocate for keeping these types of NCRR programs along with their unique and critical mission for states like Alaska intact.
The Center for Alaska Native Health Research was made possible by the IDeA program. This built crucial biomedical and health research infrastructure at the University of Alaska Fairbanks. Numerous recent health disparities NIH grant awards and successful project completions were made possible only because of this infrastructure. I am currently PI on several R24, R21, and U01 awards, and continuing the track to developing an R01 application; I credit all of these as made possible through IDeA infrastructure. These projects aim to translate existing research knowledge to address significant health disparities among Alaska Natives in mortality due to suicide, alcohol abuse, and stroke. Moreover, our university would not have committed matching funds to build our biomedical and clinical research infrastructure without the IDeA (COBRE and INBRE) grants. This allowed new research faculty and key staff hires, space, and infrastructure necessary for clinical and rural community based research in Alaska. A majority of these projects address health disparities, and many translate research knowledge in ways applicable and feasible to our unique arctic rural cultural, climactic, and geographical contexts.
It is unclear what will happen to NCRR capacity building programs with the CTSA program move to NCATS. While I am strong supporter of advancing translational science, I have concerns that specific individual NCRR programs like IDeA or RCMI might move to different centers or institutes. I am particularly concerned this may dilute the mission of these research capacity building programs, as other institutes may not share the same values as NCRR in building capacity in IDeA states. It is unclear how other ICs may manage these important programs, and I have concerns crucial resources may be diverted to other local IC objectives that differ from capacity development. At a minimum, this risks loss of important existing synergies between the NCRR programs; at worst, important progress and success in IDeA states will be abandoned.
The NCRR IDeA and RCMI programs are essential to states with developing research infrastructures like ours, best managed by the NCRR staff that have developed these programs, believe in their mission, and have expertise in capacity development through years of experience.
Sincerely,
Jim Allen, PhD
Professor of Psychology
Department of Psychology and
Center for Alaska Native Health Research
University of Alaska Fairbanks
Fairbanks, AK 99775-6480
The current gap between grant submission and the NOA is anywhere between 7 and 12 months. Accelerating research discoveries in part depends on a more rapid turnaround. This may be a reasonable place to start once NCATs begins to issue FOAs.
As a graduate student and postdoctoral fellow, I have logged many hours on instruments purchased with funds from Shared Instrumentation Grants (SIG) from the NCRR. These grants maximize efficient use of expensive instrumentation by bringing researchers with shared technical needs together, even if their specific research interests are extremely varied. I have personally been part of many interactions created by the shared use of instruments that have led to unique cross-discipline discussions, collaborations and sharing of reagents that were brought about more by chance meetings than by directed efforts at problem solving. While intentional collaborations are certainly productive, the element of chance has historically been a huge factor in scientific discovery. I am concerned that both the efficiency and the possibilities for cross-topic collaborations would be hampered if these grants were administered by another center (one that is concerned with a specific research topic). I urge you to maintain the SIG grant structure in its current form, I think they work well!
I have been following with intense interest the current changes in organization of the CTSA Centers and the overall NCRR changes related to NCATS. I am the department chair for biomedical informatics and so am very interested in that topic. I am also the director of the biomedical informatics core for our Center for Clinical and Translational Science. The CTSA’s were the first major initiative at NIH that placed the expertise of biomedical informatics on the critical path for transformation of the clinical/translational research infrastructure. It was a turning point for the field and has proved to be a key enabler of data-centric research (as all research is becoming). I hope that this focus on biomedical informatics as a core enabler is maintained when the CTSA’s move out of NCRR and become part of NCATS.
Joyce Mitchell, PhD
Associate Vice President for Health Sciences Information Technology
Professor and Chair, Department of Biomedical Informatics
University of Utah
Salt Lake City, Utah
While an emphasis on improving the therapeutic pipeline is of course something to be welcomed, I am concerned that T2, T3, T4 work will become orphaned and effectively downgraded just at a time when disease prevention and effective implementation of existing therapeutics is needed more than ever. No amount of verbal assurances will erase the strong impression that NIH is once again emphasizing disease-focused biomedical research over a true committment to improving actual human health, UNLESS NIH devotes as much thought NOW to how the NIH will support the T2-T4 work currently supported by NCRR. We need more concrete plans, more evidence that you are serious about supporting T2-T4 work. Perhaps a Task Force with the participation of top-level leaders and clear committment of resources to produce recommendations in a short timeframe would be a start.
A growing body of reports has pointed out that the promises of basic research have not been kept. Reports have come from august bodies like the Clinical Research Roundtable of the Institute of Medicine, from senior researchers like John P. A. Ioannidis, and from science writers such as Sharon Begley. They have proposed various reasons for the failure of basic discoveries to be translated into improved patient care or improved disease prevention.
Across the country, university’s have responded by building this and that “Center for Translational Research,” as if they had simply forgotten to apply their taxpayer-funded research findings to human bedside care.
The problem is not so simple and neither is the solution. Those opposed to the potential restructuring of our publicly-funded medical research endeavor seem to be concerned primarily about their own livelihood, but continuing to pay for more scientific papers reporting more factoids about the biology of animals is just more of the same dead-end glass bead trivia that drains opportunity and resources away from real public health improvements shown to provide real benefit to real people.
January 6, 2011
The CTSA Consortium- Child Health Oversight Committee (CC-CHOC) represents child health researchers across the country. Our 230 members are faculty at well respected academic medical centers and are engaged in high quality clinical and translational research. We enthusiastically support the recommendation of the NIH Scientific Management Review Board to establish a new National Center for Advancing Translational Sciences (NCATS) and endorse the importance of accelerated conduct of effective high quality research to improve the health of the nation. At the same time, we recognize that many adult disease states have their origin in early life, underscoring the importance of studying the fetal/neonatal, infant and childhood periods for better understanding of and potential prevention of disease. Consistent with the NIH Reform Act of 2006, we are committed to child health research and strongly think that child health research will be critical to any new translational center.
CC-CHOC provides a national forum to identify collaborative opportunities for facilitating child health clinical and translational research, with the goal of improving child health outcomes through high quality science. To date, through CTSA collaborations, we have established demonstration projects to:
1) move clinical trials to completion;
2) establish a federated multisite IRB model to expedite clinical trials;
3) disseminate core competencies for child health clinical and translational researchers;
4) distribute biobanks for rare disease research; and
5) track career progression of early career CTSA-affiliated child health researchers.
Moreover, we have worked in partnership with the NICHD to support the development of improved pediatric outcome measures associated with the Best Pharmaceuticals for Children Act. Working with active child health subcomittees and national organizations such as NIH, FDA, Congress (through the General Accounting Office), Industry and a variety of other national and international organizations, CC-CHOC is changing the working infrastructure to effectively move pediatric drug and device development forward.
As part of NIH’s efforts to promote translational research to improve the nation’s health, we strongly urge the board to affirm its commitment to child and family health as vital to this mission. We respectfully request that the needs of pregnant women and children be incorporated in the priorities of this new center. We offer these recommendations:
1. Utilize fully the innovations and best practices that have emerged from the NIH’s substantial investments in the CTSA network, sharing tools developed that promote the conduct of effective, efficient research;
2. Streamline and improve the scientific basis of NIH/FDA regulatory interfaces, assuring that the unique needs of pregnant women and children are taken into account;
3. Build upon efforts to standardize and improve the efficiency of institutional review boards while protecting vulnerable subjects including pregnant women and children;
4. Integrate advances in the behavioral and social sciences to better translate into improved health practices;
5. Develop the evolving national capacity for patient-centered outcomes research, including comparative effectiveness research related to children’s health and healthcare;
6. Support the emerging sciences of community engagement and dissemination of innovation as critical elements in translating advances in biomedical research in order to improve the public’s health;
7. Invest in training programs, career development, and education for future generations of clinical and translational scientists dedicated to children’s health research.
We look forward to working with you to assure the success of this new center.
Sincerely,
The CTSA Consortium- Child Health Oversight Committee
My name is Richard Fardy and I am the AP Biology and Anatomy/Physiology tecaher at Wilmington High School in Wilmington, Massachusetts. This is my 46th consecutive year of teaching the sciences in Wilmington and for the last several years, I have been closely involved with Drs. Don DeRosa and Carla Romney at City Lab in Boston.
The City Lab experience is an integral part of our AP Biology and Biotechnology programs here in Wilmington and serves as an invaluable educational resource for our students. I can think of no other single out-of-school resource which has supplied the kind of experiences through constructivist student-centered laboratory paradigms in the way and manner of City Lab. The programs they offer are unique and vital and I hope they continue to receive necessary funding.
Sincerely,
Richard W. Fardy
Science Department
Wilmington High School
159 Church Street
Wilmington, MA 01887