Date: June 16, 2003
Place: Building 31, Conference Room 10
National Institutes of Health
Bethesda, Maryland 20892
The 172nd meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on June 16, 2003, at 10:45 a.m., in Building 31, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 10:45 a.m. until adjournment at 2:25 p.m. The meeting was preceded by the closed session, from 8:30 a.m. to 10:30 a.m., for Council business and consideration of grant applications. Dr. Lawrence A. Tabak presided as Chair.
Members Present:
Dr. Louise T. Chow
Dr. Nereyda P. Clark
Dr. Samuel F. Dworkin
Dr. Howard K. Kuramitsu
Dr. Francis L. Macrina
Dr. Brian Mealey
Dr. Harold Morris
Dr. Michael Reed
Dr. Joan Reede
Ms. Kim Smykil Uhrich
Members of the Public Present:
Dr. Aida Chohayeb, Professor, Howard University, Washington, DC
Dr. Robert J. Collins, Deputy Executive Director, American Association for Dental Research, Alexandria, VA
Dr. Christopher Fox, Executive Director, International Association for Dental Research, Alexandria, VA
Ms. Gina Luke, Director, State Government Relations and Advocacy Outreach, American Dental Education Association, Washington, DC
Federal Employees Present:
National Institute of Dental and Craniofacial Research:
Dr. Lawrence A. Tabak, Director, NIDCR
Dr. Dushanka V. Kleinman, Deputy Director, NIDCR
Dr. Margo Adesanya, Senior Scientist and Program Director, Clinical Trials and Patient-Oriented Research Program, Division of Population and Health Promotion Sciences (DPHPS)
Ms. Carolyn Baum, Committee Management Specialist and Council Secretary, Office of the
Director (OD)
Dr. Henning Birkedal-Hansen, Scientific Director, NIDCR, and Director, Division of Intramural Research (DIR)
Ms. Karina Boehm, Chief, Health Promotion Branch, Office of Communications and Health Education (OCHE)
Dr. Norman S. Braveman, Assistant to the Director, OD
Dr. Patricia S. Bryant, Health Scientist Administrator and Program Director, Behavioral and Social Sciences Research Program, DPHPS
Ms. Sharrell S. Butler, Diversity Program Manager, OD
Ms. María Teresa Canto, Health Scientist Administrator and Program Director, Population Studies Program, DPHPS
Dr. Lois K. Cohen, Associate Director for International Health, NIDCR, and Director, Office of International Health (OIH)
Mr. George J. Coy, Chief, Financial Management Branch, OAM
Ms. Mary Daley, Chief Grants Management Officer, Grants Management Branch (GMB), Division of Extramural Activities (DEA)
Ms. Mary Daum, Writer, Public Information and Liaison Branch (PILB), OCHE
Dr. Raymond Dionne, Chief, Pain and Neurosensory Mechanisms Branch, DIR
Ms. Yvonne H. du Buy, Associate Director for Management, and Chief, OAM
Mr. William Foley, Grants Management Specialist, DEA
Dr. Isabel Garcia, Special Assistant for Science Transfer, OCHE, and Co-Director, Residency Program in Dental Public Health at NIDCR, DPHPS
Ms. Christen Geiler, Computer Specialist, Office of Information Technology (OIT), OD
Dr. Sharon Gordon, Special Assistant for Training, Career Development, and Education, OD
Ms. Jalaima Graham, Summer Student, DPHPS
Dr. H. George Hausch, Acting Director, DEA
Ms. Lorrayne Jackson, Specialist, Extramural Recruitment and Outreach Program, OD
Ms. Susan M. Johnson, Chief, PILB, and Acting Director, OCHE
Ms. Mary Kelly, Scientific Review Specialist, Scientific Review Branch (SRB), DEA
Dr. Lynn King, Scientific Review Administrator, DEA
Ms. Sandra King, Program Assistant, OD
Dr. Eleni Kousvelari, Chief, Cellular and Molecular Biology, Physiology, and Biotechnology Branch, Division of Basic and Translational Sciences (DBTS)
Dr. John W. Kusiak, Health Scientist Administrator and Program Director, Molecular and Cellular Neurobiology Program, DBTS
Dr. Wendy A. Liffers, Director, Office of Science Policy and Analysis (OSPA), OD
Dr. James A. Lipton, Special Assistant, Research Infrastructure and Curriculum Development Program, OD
Dr. Jack London, Deputy Scientific Director, DIR
Dr. Dennis F. Mangan, Chief, Infectious Diseases and Immunity Branch, DBTS
Dr. J. Ricardo Martinez, Executive Secretary, NADCRC, and Associate Director for Program
Development, OD
Ms. Rochelle Mendoza, Program Assistant, OD
Ms. Yewande Morgan, Dental Public Health Resident, Health Policy, Analysis and Development Branch (HPAD), DPHPS
Dr. Richard L. Mowery, Chief, Clinical, Epidemiology and Behavioral Research Branch, DPHPS
Mr. Christopher Myers, Lead Grants Management Specialist, GMB, DEA
Dr. Mostafa Nokta, Health Scientist Administrator and Program Director, AIDS and Oral Manifestations of Immunosuppression Program, DBTS
Dr. Ruth Nowjack-Raymer, Health Scientist Administrator and Program Director, Health
Disparities Research Program, DPHPS
Ms. Helen Pham, Grants Management Specialist, GMB, DEA
Dr. Bruce L. Pihlstrom, Acting Director, DPHPS
Ms. Diana Rutberg, Grants Management Specialist, GMB, DEA
Dr. Ann L. Sandberg, Acting Director, DBTS
Dr. Jaya Satish, Health Scientist Administrator, Cellular and Molecular Biology, Physiology, and Biotechnology Branch, DBTS
Dr. Robert H. Selwitz, Chief, HPAD, and Director, Residency Program in Dental Public Health at NIDCR, DPHPS
Dr. Yasaman Shirazi, Health Scientist Administrator and Program Director, Epithelial Cell Regulation and Transformation Program, DBTS
Dr. Rochelle Small, Health Scientist Administrator and Program Director, Developmental Biology and Mammalian Genetics Program, DBTS
Ms. Traci Walker, Committee Management Assistant, OD
Mr. Robert Tarwater, Grants Management Specialist, GMB, DEA
Dr. Philip Washko, Scientific Review Administrator, SRB, DEA
Ms. Anne Welkener, Financial Analyst, DEA
Ms. Dolores A. Wells, Program Analyst, OSPA, OD
Other Federal Employees:
Dr. C. R. Buchanan, Acting Assistant Medical Director for Dentistry, Department of Veterans Affairs, Washington, DC
Dr. Fred Eichmiller, Director, Paffenbarger Research Center of the ADA Health Foundation, National Institute of Standards and Technology, Department of Commerce, Gaithersburg, MD
Dr. Robert Mecklenburg, Consultant, National Cancer Institute, NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Lawrence A. Tabak, Director, NIDCR, called the meeting to order. He extended a special welcome to two new Council members: Dr. Brian Mealey and Dr. Michael Reed. Dr. Tabak invited all attendees to introduce themselves.
II. APPROVAL OF MINUTES
The minutes of the Council's meeting on February 3, 2003, were considered and unanimously approved.
III. OPERATING PROCEDURES
The Council unanimously concurred with the rules governing the Council’s operating procedures.
IV. FUTURE COUNCIL MEETING DATES
The following dates for future Council meetings were confirmed:
September 18, 2003
January 20, 2004
May 25, 2004
September 28, 2004
January 28, 2005
June 10, 2005
September 23, 2005
V. REPORT OF THE DIRECTOR
Dr. Tabak presented an overview of NIDCR activities and events since the last Council meeting, highlighting items from the written Director's Report (see Attachment III).
Activities of the NIDCR Director. Dr. Tabak said he continues to give presentations at dental schools, professional dental organizations, and scientific meetings across the country. In late March, he met with Representative Bill Young (R-FL), Chairman, House Appropriations Committee, to discuss NIDCR advances in clinical research, salivary diagnostics, and development of the concept of a “lab on a chip.” Congressman Young has been a strong advocate for the NIH.
Dr. Tabak noted that he co-chairs the NIH committee on Multidisciplinary Research Teams of the Future, in coordination with Dr. Kenneth Olden, Director, National Institute of Environmental Health Sciences. This committee is one of the four main areas in NIH Director Elias Zerhouni’s “Roadmap Plan” to identify the most compelling and exciting pursuits in science. The other three areas are Revolutionary Methods of Research, New Pathways to Discovery, and Reengineering the Clinical Research Enterprise. Dr. Tabak said that hundreds of intramural and extramural investigators are engaged in this effort and that the directors of the NIH institutes and centers (ICs) will meet with Dr. Zerhouni on June 20 to discuss the ideas proposed. Dr. Tabak also serves on the NIH Agenda-Setting Committee and the NIH Extramural Functions Review Committee.
Activities of the NIDCR Deputy Director. Dr. Dushanka V. Kleinman, Deputy Director, NIDCR, was unable to attend the Council meeting because she was chairing a meeting of Public Health Service dental officers, in her role as Chief Dental Officer, U.S. Public Health Service (USPHS). Dr. Tabak noted that Dr. Kleinman recently helped to organize a conference on Dentistry’s Role in Responding to Bioterrorism and Other Catastrophic Events, which was jointly sponsored by the American Dental Association and USPHS. Dr. Kleinman also presented a talk at the conference. Dr. Tabak noted that the conference was highly successful and attracted more than 300 private practice and public health dentists, dental educators, military dental officers, dental researchers, and dental team members.
Dr. Tabak also reported that Dr. Kleinman participated in the preparation of the National Call to Action to Promote Oral Health, which was released by Surgeon General Richard H. Carmona at the National Oral Health Conference, held in Milwaukee, Wisconsin, on April 29. The document is available at http://www.nidcr.nih.gov/DataStatistics/SurgeonGeneral/NationalCalltoAction/default.htm. Dr. Tabak urged the Council members to read this report, which was called for in Oral Health in America: A Report of the Surgeon General and builds on the Healthy People 2010 report. The Call to Action presents five actions to improve the nation’s oral health and delineates specific implementation strategies for each action. It emphasizes that oral health is essential to general health and well-being and that efforts are needed to reduce disparities in oral health.
Budget Update. Dr. Tabak reported that NIDCR’s final appropriation for fiscal year (FY) 2003 is $371.6 million. The FY 2004 President’s Budget requests $382.4 million for NIDCR (including AIDS), which is an increase of approximately 2.9 percent over the FY 2003 appropriation. (Details on the distribution of these funds across NIDCR mechanisms for FY 2003 and FY 2004 are attached to the written Report of the Director.)
Dr. Tabak said that the FY 2004 appropriations hearings in the House differed from years past and comprised three separate hearings—on the state of NIH, the NIH budget overview, and biodefense. Dr. Zerhouni testified on behalf of the entire NIH, and IC directors were available to respond to specific questions. Dr. Tabak attended the hearing on the state of NIH, held on April 2, and had an opportunity to respond to a question about research on salivary diagnostics. The hearing on the NIH budget overview was held on April 8. The Senate hearing on the NIH budget request also was held on April 8 and, as in previous years, the NIH Director testified on behalf of the NIH, with the IC directors in attendance. The NIDCR Director’s statement for the Senate hearing is available at http://www.nidcr.nih.gov/AboutUs/BudgetCongressionalStatements/CongressionalJustifications/.
DHHS/NIH Activities. Dr. Tabak stated that the oral health co-lead agencies within the U.S. Department of Health and Human Services (DHHS) signed a Memorandum of Understanding (MOU) with the American Association for Dental Research (AADR) on May 7 for Healthy People 2010 activities. The DHHS has already established an MOU with the Academy of General Dentistry and is developing an MOU with Oral Health America.
Dr. Tabak reported that President Bush named Dr. Charles W. Grim, a dentist, as Director of the Indian Health Service, DHHS. Information about this appointment is available on the NIDCR website. On April 15, Dr. Nora Volkow assumed her new position as Director, National Institute on Drug Abuse, NIH. A psychiatrist, she is known for her work on the brain’s dopamine system.
On February 3, President Bush spoke at NIH to promote Project Bio-Shield, a major White House priority. The purpose of this $5.6 billion research project is to develop and stockpile vaccines and treatments for diseases that could become weapons of bioterror.
Dr. Tabak also noted that NIH is revitalizing the NIH Pain Consortium and that NIDCR is taking the lead in this effort, in coordination with the National Institute of Neurological Disorders and Stroke and the National Institute of Nursing Research. The consortium, which received its charge from Dr. Zerhouni on June 10, will promote pain research and stimulate collaborative interdisciplinary research across the ICs both extramurally and intramurally. Dr. Tabak emphasized that pain is a critical national health problem that accounts for nearly 40 million health care visits annually and costs more than $100 billion each year in health care and lost productivity.
Scientific Advances. Dr. Tabak highlighted the discovery of a unique source of postnatal stem cells, recently accomplished by Dr. Songtao Shi and colleagues in the NIDCR intramural laboratories. The scientists named the cells SHED (for stem cells from human exfoliated deciduous teeth) because the cells are found in the dental pulp of “baby” teeth. The cells are unique, compared to many “adult” stem cells in the body, and young children’s teeth may be an important and easily accessible source for these cells, which could be manipulated to repair damaged teeth, induce bone regeneration, and treat neural injury or disease. Dr. Tabak referred the Council to other exciting advances described in the written Report of the Director.
Meetings and Workshops. Dr. Tabak stated that NIDCR staff and grantees gave various presentations at the National Oral Health Conference, held in Milwaukee in April. At the annual meeting of the AADR, held in San Antonio in March, staff sponsored several symposia. NIDCR received positive feedback especially on two symposia, Clinical Research Opportunities for Dental Educators and Researchers, which was attended by more than 200 individuals, and Community-Based Participatory Research: An Essential Approach for Reducing Oral Health Disparities, which included presentations on the lessons learned by NIDCR Centers for Research to Reduce Oral Health Disparities (CRROHD). Dr. Tabak reported that NIDCR convened the second annual meeting of the CRROHD on April 7-8, which included a dialogue between NIDCR investigators and Dr. John Ruffin, Director, National Center on Minority Health and Health Disparities, NIH.
On November 3, NIDCR will cosponsor the 2003 David Barmes Global Health Lecture in conjunction with the Fogarty International Center, NIH. The 2003 lecturer will be Dr. Bruce Alberts, President, National Academies of Science.
Additional information on these and other NIDCR activities is provided in the written Director's Report (Attachment III).
VI. CONCEPT CLEARANCE
Dr. Sharon Gordon, Special Assistant for Training, Career Development, and Education, Office of the Director (OD), NIDCR, presented the concept for a Request for Proposals (RFP) to enhance fundamental training in clinical research related to oral, dental, and craniofacial research. Dr. Gordon noted that recent scientific advances hold great promise for improvements in health, but that observations in the laboratory have far outpaced the ability of researchers to test advances in clinical settings. In some part, this disconnect is due to a shortage of trained clinical researchers, a problem that has been documented in numerous studies and addressed in many Federal reports. Dr. Gordon referred the Council to a recent review of this issue as it relates to the dental profession. Entitled “Capacity for Training in Clinical Research: Status and Opportunities,” this review was published in the June 2003 issue of the Journal of Dental Education (Gordon SM, Heft MW, Dionne RA, et al., vol. 67, no. 6, pp. 622-29). A copy of the article was provided to the Council members and made available to all attendees.
Dr. Gordon commented that existing training opportunities have addressed some gaps in clinical research training, but that persistent barriers remain. Rigorous, interdisciplinary clinical research training is especially needed. She said that the proposed program would support fundamental clinical research training for all members of the clinical research team and would span training at many levels, from certificate to Ph.D. The program would be institutionally based and would link dental schools with schools of medicine and schools of public health. It also would facilitate dental schools’ access to existing NIH resources for training, such as the Clinical Research Curriculum Development Award (K30) and the General Clinical Research Center (GCRC) program. Dr. Gordon said that NIDCR anticipates that the proposed program would result in a cadre of well-trained clinical investigators with expertise relevant to oral, dental, and craniofacial health.
The Council unanimously approved the concept.
VII. CHALLENGES IN MULTICENTER CLINICAL TRIALS OF
ENDOSSEOUS DENTAL IMPLANTS
Dr. Harold Morris, Council member and Director, Clinical Dental Research Center, U.S. Department of Veterans Affairs (VA) Medical Center, Ann Arbor, Michigan summarized the VA’s experience with multicenter, multidisciplinary clinical trials of endosseous dental implants. He based his presentation on a previously published report, entitled “3-Year Results from the VA Multicenter, Randomized, Prospective Implant Study” (Annals of Periodontology, vol. 5, no. 1, December 2000) and more recent updates in the database.
Dr. Morris noted that, over the past 13 years, the VA has supported two prospective clinical trials of endosseous dental implants. The first study was a randomized study of five different implant designs; the second study was not randomized and focused on one specific new and innovative implant design. He presented data based largely on the first study, which involved 3,000 implants, 600 patients, 30 VA Medical Centers selected from various geographical regions, and 90 dentists. The second study was similar in basic design and included 1,500 implants. Dr. Morris highlighted the many challenges that these clinical studies present because of the large number of cases, patients, centers, and dentists. He suggested that the VA offers significant advantages for clinical trials, because of its resident population and the opportunity to access post-mortem specimens to confirm clinical observations.
Dr. Morris noted that understanding the complexities of, and events at, the bone–implant interface is extremely important and that, to date, most of this information has been gained from histological studies of animal specimens. Clinical research is important for establishing the efficacy and effectiveness of implants in humans. Dr. Morris noted that the designs of studies to establish efficacy, effectiveness, and “global clinical relevance” differ (e.g., number of variables that can be controlled, internal and external validity, number and demographics of participating patients and dentists). He highlighted the role of the participating dentists (i.e., their training backgrounds and clinical experience) as an important variable affecting the efficacy, effectiveness, and clinical relevance of final results. He emphasized the need for mechanisms to ensure that this variable is considered, controlled for to the extent possible, and monitored in clinical studies. The overall influence of the participating dentist and the influence that patient variables may have on the final outcomes of a study are extremely important considerations in ensuring the validity of final data.
Citing data from the first VA study, in which researchers compared five different implant designs randomized to different jaw locations, Dr. Morris noted that the findings suggest that use of a hydroxylapatite (HA)-coated implant has the potential to moderate the influence of the surgical trauma and the experience of the treating dentist during placement of the implant. The particular HA-coated implants used in the VA study performed well in all jaw regions and had greater survival rates over time, compared to non-HA-coated implants under all conditions. The non-HA-coated implants that failed did so within the first year following placement. An assessment of implant stability during the course of the study indicated that HA-coated implants became stable earlier than non-HA-coated implants, which gradually increased in stability over time. This finding suggested that HA-coated implants may actually be capable of being loaded earlier than non-HA-coated implants. Changes in implant stability of the non-HA-implants increased over 9 to 15 months. Also, changes in implant stability over time were observed for each bone density and, again, this variation was greater for non-HA-coated implants than for HA-coated implants.
Dr. Morris suggested that short- and long-term survival of non HA-coated implants are not related to the design of the implant and functional stresses, but to the amount of surgical trauma developed during surgery to place the implant. This trauma is increased with the instrumentation procedures required for a complex design. Dr. Morris indicated that the cylindrical implant has the simplest placement procedures, which result in better survival. Other factors that are more important than implant design are the skill and experience levels of the dentist. A direct comparison between HA-coated implants and non-HA-implants placed and restored in the same bone density by the same dentist showed that the performance of the HA-coated implant was always better. When dentists were grouped according to success/failures (top 25 percent, middle 50 percent, and lower 25 percent), the HA-coated cylindrical implant consistently had the best survival rate in all groups. Other patient factors (e.g., diabetes, smoking) were studied, but did not appear to dramatically influence implant survival, as did surgical trauma.
Dr. Morris highlighted four topics that he believes are especially promising areas of research: (1) a better understanding of HA and bone responses, (2) benefits versus risks associated with use of antibiotics for implant placement, (3) bone growth and enhancement factors, and (4) bone augmentation materials. He discouraged additional NIDCR research on new implant designs, saying that most existing implant designs work well in the hands of highly experienced dentists.
In closing, Dr. Morris stated that the VA Clinical Research Group has just completed a study of a new and innovative implant design from Germany and that, if design is a major factor in survival, this new implant has many new features that will have a major impact on implant dentistry in the future. The new design transfers the functional stresses to the resilient trabecular bone and away from the dense cortical bone. Trabecular bone responds to microstrains within physiological limits by increasing the density of bone around the implant, an effect that should increase clinical survival of the implant. The database from this study is being analyzed, and a special report is being prepared.
Discussion
Dr. Morris emphasized that the results which he presented pertained to the particular HA-coated implant that the VA included in its long-term clinical study. He agreed that the chemical composition of HA varies widely and that the manner in which the HA is applied can produce major changes in the chemical composition of the HA coating. The Council noted that the VA sample was largely male and older (> 60 years) and that the survivability of an implant may relate to other factors such as patient’s age, degree of edentulousness, gender, and race/ethnicity. Dr. Morris commented that, based on the large VA database, age, race, gender, and health status were minor factors and that the most significant factor was the surgical trauma produced during placement of the implant. The skill and experience of the dentist are much more important than any other variables.
VIII. REPORT FROM CARIES VACCINE PANEL
Dr. Tabak reported on the deliberations and conclusions of the NIDCR Panel on Caries Vaccine. The panel is one of a series of expert panels convened by NIDCR to provide an update on scientific areas of emphasis and opportunity. The NIDCR convened the Panel on Caries Vaccine to discuss the breadth of issues related to development of a vaccine against dental caries—from the feasibility and safety of developing and testing a vaccine to marketplace realities. The panel met on January 28, 2003, to hear the latest findings from scientific experts in academia and industry and to identify and deliberate the issues. The panel’s report, which was distributed to the Council and made available to all attendees, summarizes the presentations, discussion, and recommendations from the meeting. The report also is available on the NIDCR website.
Dr. Tabak reported that the panel identified three sets of issues: scientific, ethical, and economic. Scientific issues highlighted by the panel include the need to (i) obtain additional longitudinal data to document the relationship between levels of Streptococcus mutans, antibodies, and dental caries; (ii) identify all organisms that could cause dental caries (e.g., if S. mutans were decreased); (iii) ensure the safety of any antigens used to immunize young children against dental caries; and (iv) more precisely define the target populations and the rationale for a caries vaccine. The panel suggested that one approach for obtaining additional longitudinal data would be to study all innate immune factors in children who have not been colonized with S. mutans, but whose mothers have high caries levels.
Two economic issues discussed by the panel are the need to (i) identify ways to overcome the public’s general perception that vaccines can alter normal development; and (ii) better define the economic and quality-of-life burden of caries over time. The panel suggested that a caries vaccine is not likely to reach the marketplace, especially if it is not recommended by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices for routine use in all children. To gain this recommendation, researchers would have to calculate the economic risks and benefits of a vaccine and prove that it would save health care costs.
As documented in its report, the panel concluded that NIDCR should aim to establish proof of principle, and “stop short” of Phase 3 trials, if it continues research toward development of a caries vaccine. The panel suggested that, because of the “real-world” barriers to a caries vaccine, NIDCR should consider using its resources to develop alternative means of solving the caries problem.
Dr. Tabak emphasized that the research community and the public should not misinterpret the panel’s conclusions as indicating that dental caries are not an important health problem or that mucosal immunology is not an important research area. The NIDCR considers dental caries to be a very important problem and will continue to support research on dental caries and on mucosal immunology. Dr. Tabak highlighted the continuing need for early diagnoses, effective treatments, and prevention of dental caries, particularly among populations that bear a disproportionately greater burden of this disease.
Discussion
Dr. Tabak welcomed the Council’s comments on the panel’s report. The Council offered that the report accurately describes the issues pertaining to development of a caries vaccine. The members generally agreed with the panel’s conclusions, but noted that scientists have established that dental caries, an infectious disease, is caused by one microorganism, Streptococcus mutans. The Council strongly urged NIDCR to continue to support research toward establishing proof of principle and conducting early clinical trials to establish the safety and efficacy of candidate vaccines. The members emphasized that research on a caries vaccine has value (e.g., it has led to discovery of virulence factors) and that NIDCR and the research community should not “back away” from studies that could lead to a vaccine to protect against S. mutans. The Council urged NIDCR to clearly communicate to the research community its intent to continue support for research on oral microorganisms toward the potential development of candidate vaccines. The members suggested that researchers should focus on passive immunization approaches and that clinical trials should be conducted in adults only.
Dr. Tabak agreed that basic research on mucosal immunity and antigen identification must continue, while researchers also explore additional biological (glucosyltransferase, other small-molecule inhibitors of glucosyltransfer) and nonbiological (e.g., dietary, fluoride use) interventions against dental caries. The ultimate aim is to develop the most appropriate strategies to combat dental caries, especially in populations that continue to disproportionately suffer the greatest burden of the disease. Dr. Tabak said that the panel’s deliberations and recommendations will serve to guide NIDCR’s continued efforts in this direction.
IX. UPDATE ON STRATEGIC PLAN
Dr. Isabel Garcia, Special Assistant for Science Transfer, Office of Communications and Health Education, NIDCR, described the process for updating the NIDCR Strategic Plan, the comments received on the draft revision and the changes made, and “next steps.” Updating of the plan began in fall 2002, and a draft revision was presented to the Council at its meeting in February 2003. Since then, NIDCR obtained public input on the draft revision via its website, from February until the end of April, and offered two opportunities for “face-to-face” input—at a stakeholders meeting during the first week of April and at the NIDCR Patient Advocates Forum, held on May 5.
Dr. Garcia noted that the input received from all venues has been outstanding and very helpful. The responses addressed all areas of the plan and ranged from very general comments to detailed word changes. Via its website, NIDCR received comments from 40 individuals representing 32 organizations. Approximately one-half of the comments were from dental schools, and the remaining comments were from patient advocacy groups, research organizations and industry, and educational institutions. At the stakeholder meeting, representatives from 23 organizations participated in three workgroup sessions, providing detailed feedback and recommending changes. At the Patient Advocates Forum, 17 participants, representing millions of individuals affected by dental, oral, and craniofacial diseases, had an opportunity to comment as well.
Dr. Garcia said that NIDCR reviewed and organized all the comments into 147 distinct topics, or issues, and discussed specific items, as needed, with Dr. Tabak and the internal NIDCR Strategic Plan Update Committee. She noted that more than half of the comments received were fully or partially addressed in changes NIDCR made to the draft revision. She listed the specific changes made.
Dr. Garcia emphasized that all the strategic initiatives, goals, and objectives in the plan are interrelated and linked. The three major areas to achieve the NIDCR mission—research opportunities, research capacity, and communication—are the same as before and, except for minor changes to one goal, the seven goals are the same. These goals relate, and contribute, to the DHHS and NIH strategic plans that have been prepared in response to the Government Performance Results Act.
Dr. Garcia commented that the “real work” now begins; that is, implementing the NIDCR Strategic Plan. This work will entail broadly communicating the priorities and content of the plan and ensuring that the plan is used. Toward these ends, NIDCR will be developing a concrete and measurable implementation strategy for the plan.
In closing, Dr. Garcia expressed appreciation to all the individuals and organizations that contributed to the NIDCR Strategic Plan. A copy of the updated plan, with changes highlighted, was provided to the Council and made available to all attendees.
Discussion
The Council commended NIDCR for preparing a “beautiful document” that is easy to read and understand. Dr. Tabak thanked Dr. Garcia for her leadership of the strategic planning effort. The Council requested one change, on page 12, line 500, to read “chronic pain and disability associated with TMJDs and other pain conditions.” Hearing no other changes, Dr. Tabak noted that the Council adopts the plan, with the change indicated. He said that the plan will be available on the NIDCR website and that NIDCR will continue its dialogue with the Council and broader community as staff begins to address implementation.
X. UPDATE ON DENTAL SCHOOL INITIATIVE
Dr. James A. Lipton, Special Assistant, Research Infrastructure and Curriculum Development Program, OD, NIDCR, described NIDCR initiatives during the past year to enhance research capabilities in U.S. dental schools. He also presented ideas for evaluating the success of these initiatives. The development of NIDCR initiatives to strengthen dental schools’ participation in research was stimulated by discussions at the 2001 annual meeting of dental school deans, which focused on strengths and weaknesses of research activities at U.S. dental schools. Data presented at the meeting showed that 41 dental schools received grant support from NIDCR in FY 2001 and that the bulk of NIDCR funds awarded to dental schools goes to relatively few institutions. Of the 41 schools, 4 received more than $6 million in support. Only 10 percent of the dental schools accounted for 51 percent of the NIDCR funds awarded to dental schools, and only 20 percent accounted for 75 percent of NIDCR funds (in FY 2002, the percent of dental schools increased to 15 percent and almost 30 percent, respectively).
Dr. Lipton noted that these data led NIDCR to consider initiatives that could help more dental schools (i) enhance their research capabilities and (ii) integrate science findings into clinical training. The goal is to establish a broader base of dental institutions that have a critical mass of research as an integral component of their educational missions. To accomplish this goal, NIDCR has established two new initiatives to complement its continuing support of research training and career development awards. The new components are the Dental Schools Research Infrastructure Program and Oral Health Curriculum Development Program.
The NIDCR first implemented the Dental Schools Research Infrastructure Program. Under this initiative, NIDCR offers two types of award programs: (a) Research Infrastructure and Capacity Building for Minority Dental Institutions to Reduce Oral Health Disparities (U24 grants) and (b) Enhancement of Research Infrastructure in U.S. Dental Schools (R24 planning grants and U24 implementation grants). Dr. Lipton noted that NIDCR already supports two grants under (a), at the University of Puerto Rico and Meharry Medical College, School of Dentistry. For (b), the Council will review 35 applications for R24 planning grants at the present meeting, and applications for the U24 implementation grants (which can be submitted by R24 awardees and non-R24 awardees) will be due in April 2004.
Dr. Lipton commented that use of the Cooperative Agreement (U24) mechanism enables NIDCR staff to be actively involved in activities conducted under the award—working with recipients, for example, to plan, conduct assessments, develop collaborations, organize meetings, evaluate, and disseminate information. For schools needing funds to enhance or renovate their physical plants, NIDCR will facilitate interactions with the National Center for Research Resources (NCRR), NIH, which supports these activities.
The purposes of the second initiative—Oral Health Curriculum Development Program—are to (a) infuse an appreciation of science and the results of scientific research in the dental school curriculum and (b) strengthen the research component of dental education and enhance the application of basic and clinical research findings to clinical training. By helping schools strengthen their dental curricula, NIDCR hopes to also improve dental practice and to foster research- and evidence-based care. The initiative encourages both students and faculty to participate in scholarly activities, monitor the latest science, and develop an appreciation for research. For this initiative, NIDCR is using the R25 award mechanism, which allows applicants to submit applications three times a year in response to the NIDCR program announcement. Dr.Lipton said that NIDCR is considering, in addition, a second R25 program, to support development of curriculum in particular research areas (e.g., genetics, genomics, proteomics, infectious or inflammatory diseases) that will be important in the delivery of oral health care in the future and in which few, if any, dental schools have expertise.
Dr. Lipton conveyed NIDCR’s thinking on ways to evaluate these new initiatives, and he asked for Council’s input. He noted that, in order for NIDCR to use its resources most effectively, evaluation of the programs is a key concern. Two major questions are: (i) What factors make for a successful research enterprise at an academic institution? (ii) How can success be measured (e.g., by receipt of NIH research and training grants; faculty honors, publications, and citations; impact on students and faculty; change in the “culture” of dental education)?
Dr. Lipton noted that NIDCR has begun to develop a Research Infrastructure Profile that will include baseline data, available in a searchable database, and input and outcome measures for each dental school. Staff are collaborating with dental research and professional organizations to identify the best sources of data for the input measures which include, for example, percent of faculty engaged in research; number and percent of faculty holding joint appointments in other university schools or departments; research space, equipment, personnel, and funding; and a school’s “culture” of research and education. Outcome measures would include, for example, research and training grant support from NIH and from other sources, bibliometric data, and research honors and awards. Preliminary evaluation data indicate, for example, that dental schools receiving the most NIDCR funding are not the same as those receiving the most funding from NIH institutes other than NIDCR.
In evaluating the new programs, NIDCR proposes to track changes in the Research Infrastructure Profile for institutions receiving support under the new programs, compared to those not receiving support, and to utilize reports from NIDCR staff and advisory committees for the programs. Dr. Lipton said that the data collected also could be useful for addressing larger issues in the future, such as: How are dental schools viewed in academia (e.g., within health science centers, parent universities)? What should be expected of dental schools and postgraduate training programs regarding the performance of research? How can incorporation of research findings into clinical practice be facilitated?
Dr. Lipton commented that, to promote the new initiatives, NIDCR will identify and meet with other NIH staff involved in research infrastructure programs (e.g., NCRR), establish an Inter-Agency Research Infrastructure Interest Group, foster communications within NIDCR, and generate support for the initiatives among constituent and stakeholder groups such as professional dental organizations. He encouraged Council members to communicate directly with him and with Ms. Lorrayne Jackson, Specialist, Extramural Recruitment and Outreach Program, OD, regarding the initiatives and programs.
Discussion
The Council commented that the two NIDCR initiatives are much needed. The Council also highlighted two related needs—to enhance clinical research training and to increase the pipeline of research-interested individuals entering into dental school. Dr. Lipton noted that clinical research training is a priority at NIDCR and across NIH and that NIDCR’s training and career development award programs are complementary and integral to the new initiatives. Dr. Gordon commented that the aim of the new initiatives is specifically to strengthen the partnership between NIDCR and dental schools and to increase dental schools’ access to research resources.
Ms. Jackson mentioned that NIDCR has created within OD a new “virtual office” to centralize its training and career development activities. She noted that NIDCR is thinking very broadly about creative ways to identify and pursue opportunities at the K-12 level that would result in an increase in the pipeline of new dental students interested in research. In discussions with the National Institute of General Medical Sciences, NIDCR is addressing possible mechanisms to support research interests of students in college and pre-dental school programs. Ms. Jackson welcomed the Council’s advice. The Council suggested that tapping into, and linking with, existing programs would be an effective way to communicate NIDCR’s interests in this area.
XI. ADJOURN TO KRESHOVER LECTURE
The Council adjourned the open session to attend the 2003 NIDCR Seymour J. Kreshover Lecture, which was held in the Masur Auditorium at NIH. The lecturer was Dr. Robert Langer, an internationally known and distinguished leader in biotechnology and materials science. His topic was “Biomaterials and How They Will Change Our Lives.” Dr. Langer is the Kenneth J. Germeshausen Professor of Chemical and Biomedical Engineering at the Massachusetts Institute of Technology. In 2002, Forbes Magazine selected Dr. Langer as one of the 15 innovators worldwide who will reinvent the future, and in 2001, Time Magazine and CNN named Dr. Langer as one of the 100 most important people in America and one of the top 18 people in science and medicine. NIDCR established the Kreshover Lecture series in 1983 to recognize outstanding accomplishments in basic and clinical research and to honor distinguished scientists who have made important contributions in research areas directly related to NIDCR interests. Dr. Seymour J. Kreshover was Director, National Institute of Dental Research, from 1966 until 1975. The lecture was webcast at http://videocast.nih.gov.
CLOSED PORTION OF THE MEETING
This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
There was a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions, and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.
XII. REVIEW OF APPLICATIONS
Grant Review
The Council considered 500 applications requesting $90,015,348 in total costs. The Council recommended 417 applications for a total cost of $74,154,434 (see Attachment II).
ADJOURNMENT
The meeting was adjourned at 2:25 p.m. on June 16, 2003.
CERTIFICATION
I hereby certify that the foregoing minutes are accurate and complete.
_____________________________ _____________________________
Dr. Lawrence A. Tabak Dr. J. Ricardo Martinez
Chairperson Executive Secretary
National Advisory Dental and National Advisory Dental and
Craniofacial Research Council and Craniofacial Research Council
ATTACHMENTS
I. Roster of Council Members
II. Table of Council Actions
III. Director's Report to the NADCRC, June 2003
NOTE: A complete set of open-portion handouts is available
from the Executive Secretary.