Department of Health and Human Services
Public Health Service
National Institutes of Health
John E. Fogarty International Center for Advanced Study in the Health Sciences
Seventy-ninth Meeting of the Advisory Board
Minutes of Meeting
May 13, 2014
The John E. Fogarty International center for Advanced Study in the Health Sciences (FIC) convened the seventy-ninth meeting of its Advisory Board on Tuesday, May 13, 2014 at 9:00 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The closed session was held on May 13, 2014, prior to the open session meeting, as provided in Sections 552(b)(4) and 552(b)(6), Title 5, U.S. Code, and Section 10(d) of Public Law 92-463, for the review, discussion and evaluation of grant applications and related information. The meeting was open to the public on May 13, 2014 at 9:30 a.m., until adjournment at 3:30 p.m. Dr. Roger I. Glass, Director, FIC, presided. The Board roster is appended as Attachment 1.
Attendee Information
Board Members Present
Roger I. Glass, M.D., Ph.D. (Chair)
Michelle Barry, M.D.
Wafaa El-Sadr, M.D., M.P.H.
George C. Hill, Ph.D.
King Holmes, Ph.D., M.D.
Joseph Kolars, M.D.
Michael Merson, M.D.
Stephen Morrison, Ph.D.
Bill Tierney, M.D.
Board Members Absent
Gail Cassell, Ph.D., D.Sc. (Hon)
Rebecca Richards-Kortum, M.D., Ph.D.
Derek Yach, M.B.Ch.B. (Hon)
Members of the Public Present
Peter Agre
Neal Brandes, USAID
Miliad Derbeu
Sameh El-Saharty, World Bank
Peter Ndumbe
Ariel Pablos-Mendez, USAID
Ram Sasisekharan
Federal Agency Representatives Present
Nalini Anand, FIC
Farah Bader, FIC
Deshire Belis, NHLBI
Rick Berzon, NIMHD
Danielle Bielenstein, FIC
Rachel Bishop, NEI
Katrina Blair, FIC
Joel Bremen, FIC
Kenneth Bridbord, FIC
Bruce Butrum, FIC
Pat Lee Callahan, FIC
Tina Chung, FIC
Lois Cohen, FIC
Dexter Collins, FIC
Jill Conley, HHMI
Ann Davis, FIC
Anna Ellis, FIC
Michael Engelgru, NHLBI
Jeffrey Gray, FIC
Paul Gresham, NICHD
Tom Gross, NCI
Gray Handley, NIAID
George Herrfurth, FIC
James Herrington, FIC
Christine Jessup, FIC
Robert Kaplan, AHRQ
Flora Katz, FIC
Walter Koroshetz, NINDS
Linda Kupfer, FIC
Vesna Kutlesic, NICHD
Judy Levin, FIC
Marya Levintova, FIC
Enid Light, NIMH
Yuan Liu, NINDS
Jeanne McDermot, FIC
George C. Mensah, NHLBI
Kathleen Michels, FIC
Mark Miller, FIC
Vivian Pinn, FIC
Laura Povlich, FIC
Ann Puderbaugh, FIC
Myat Htoo Razak, FIC
Joshua Rosenthal, FIC
Maria Said, FIC
Lana Shekim, NIDCD
Hillary Sigmon, FIC
Marcia Smith, FIC
Rachel Sturk, FIC
Hannah Valantine, NIH OD
Stacy Wallick, FIC
Melissa Wan, FIC
Liz Whittington, FIC
Kristen Weymouth, FIC
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Director's Update and Discussion of Current and Planned FIC Activities
Dr. Roger Glass
Dr. Glass called the meeting to order and welcomed those present, noting the presence of the visiting MEPI investigators. He commented that the strategic plan had been discussed at a number of the previous meetings, and he announced that the plan is now available for review on the web. It highlights five goals that will be on the agenda for the next five years:
- Building research capacity including individuals, institutions and networks;
- Stimulating innovation and evaluation of technologies;
- Supporting research and research training in implementation science;
- Advancing research on prevention and control of both communicable and non-communicable diseases; and
- Building and strengthening partnerships.
Dr. Glass mentioned a number of personnel changes since the last meeting. Michael Johnson stepped down as Fogarty's deputy director to become a senior advisor to FIC, working with OGAC in Geneva. NINDS Director Walter Koroshetz will lead the search team to find a new deputy director. Advisory Board member Bill Tierney is serving on the Advisory Council, on behalf of FIC, for the NIH-wide initiative Big Data to Knowledge (BD2K), an important project for the future to take advantage of big data analysis. Yvonne Maddox, former deputy director of NICHD has been appointed Acting Director of the National Institute on Minority Health and Health Disparities (NIMHD). Hannah Valantine, M.D., from Stanford University, has been named NIH's first Chief Officer for Scientific Workforce Diversity. Deborah Birx has been appointed U.S. Ambassador-at-Large and U.S. Global AIDS Coordinator, succeeding Eric Goosby. Ambassador Jimmy Kolker is the new Assistant Secretary for Global Affairs at DHHS, and finally, Glenda Gray has assumed leadership of the South African Medical Research Council, formerly headed by Salim Abdool Karim. Both were Fogarty grantees.
Dr. Glass commented on the participation of six distinguished NIH Institute Directors at the February 11-12 tenth anniversary of Brain Disorders Across the Lifespan Program. This important grant program, supported by OBSSR, NIA, NICHD, NIEHS, NINDS and NIMH, has awarded entry grants (R21) and more than 40 have been subsequently picked up as major grants (R01) by the other ICs.
In March, an NIH-Mexico Workshop on diabetes celebrated the rejuvenation of a project conceived three years ago on the use of mobile phone technology to address issues related to diabetes. The new director of the Mexican NIH has indicated an interest in promoting parallel funding programs for diabetes research that would benefit both Mexican citizens and Hispanics and Native Americans in the U.S., two populations with very high rates of diabetes. One of the funding supporters of this program has been the Carlos Slim Foundation, which has also sponsored research in genetics and the development of cell phone technology to monitor glucose, exercise, calorie intake and development of a retinoscope using phones to photograph retinas. Dr. Glass added that Mexico is looking at a sugar tax levy to reduce sugar consumption.
In the area of health diplomacy, Dr. Glass mentioned the negative impact of Uganda's anti-homosexual legislation. NIH has over a hundred grants in Uganda, though none related to MSM. On the positive side, the U.S. State Department has funded two grants from its Biosecurity Engagement Program. Fogarty has been instrumental in making these grants possible.
Dr. Glass congratulated Jim Herrington, Director of FIC's Division of International Relations, for shepherding a grad study course under the auspices of NIH's Foundation for the Advancement of Education in the Sciences (FAES). Dr. Herrington noted that it is FAES's first global health course started by FIC's Linda Kupfer in 2011. The course has drawn about 25 students each semester and offers two credits for completion. Anyone, in or outside NIH is welcome to participate in the 19-week course. Dr. Glass also stated that Dr. Herrington is involved in the World RePORT, a compilation of research activities and resources sponsored by nine agencies. The World RePORT at first covered Africa, but has been expanded to include South Asia and East Asia/Pacific regions.
Dr. Glass commented that FIC participated in a meeting on April 8, sponsored by the World Bank, USAID and WHO, on barriers and facilitators to successful implementation research and delivery science. NHLBI had a program for five years with $50 million in funding directed at low- and middle-income countries that established 11 centers of excellence for cardiovascular disease. Although it had a positive impact, the institute has decided to redirect resources and that program has been ended. Over 30 Fogarty fellows had trained in those centers of excellence and Michael Merson was an important supporter of that program. Dr. Merson expressed his concern that the program, which was hugely successful, was so short-lived.
The Consortium of Universities for Global Health held its 5th annual conference in Washington on May 10-12, at which Fogarty participated in five sessions. One session with the MEPI PIs, one with a panel of four IC Directors, and one chaired by the FIC director. Dr. Glass mentioned that five Board members also participated in the conference – Drs. Barry, Holmes, El-Sadr, Kolars and Morrison. He observed that in the future the conference might consider other areas of interest, such as global law, global engineering, global business practices and behavioral science.
Dr. Glass recalled for the Board that King Holmes was the recipient of Canada's 2013 Gairdner Award for his contributions to the prevention and treatment of STDs. This year the award went to Satoshi Omura for his discovery of Streptomyces avermitilis, from which ivermectin, an anti-parasitic drug, is derived.
Dr. Glass mentioned that next week will be Dr. Collins' first trip to Brazil, and not only making it his fourth trip to the BRICS (Brazil, Russia, India, China and South Africa) countries he has visited – only Russia remains – but the first ever trip by a sitting NIH Director to the country. The trip was preceded by an exploratory visit by Gray Handley, Lisa Stevens and Kevin Bialy, to work on a partnership agreement, still pending, although there are other agreements in the works with the State of Sao Paulo and the private sector company, FIOCRUZ.
Dr. Glass said that the PEPFAR annual meeting in Durban would be an opportunity to promote the MEPI program. The NIH support comes from a $15 million pledge (over five years) from the Director's Common Fund and a similar amount from seven ICs and the Office of AIDS Research (OAR). The details of the funding must be worked out by the parties involved.
The Global Alliance for Chronic Diseases (GACD) will meet in Shanghai in July. Susan Shurin had been Chair of the group for the last year or so; she is leaving NIH in June but will continue with NCI as a consultant. The first RFA call by the Alliance was for research related to hypertension, and it will be followed by second call for diabetes, and the third call will probably be for research on smoking, cancer, lung disease or mental health. Each member of the Alliance supports the research through grants which they control individually.
Also in July is the annual Fogarty Global Health Fellows and Scholars and Fulbright-Fogarty Fellows week long orientation. Starting with 20 fellows eight years ago, the number has grown to 93 as of last year. Eighteen ICs have been involved. Following a visit by Bill Gates in January to present the Barmes Lecture, the First Annual NIH-Bill and Melinda Gates Foundation meeting was scheduled for July 8-9, and will involve 22 members of the Gates Foundation returning to NIH to participate in a series of sessions on important global health issues.
In early August, about 47 African leaders will convene for the African Leaders Summit, which will focus on cooperation and economic development. Fogarty has been working to get a health component added to the agendas of meetings like the Summit. At the same time the MEPI Annual meeting in Mozambique will review MEPI's first four years.
Dr. Glass concluded his comments with a review of the meeting calendar through 2015 – Advisory Board meetings are scheduled for September 15-16, 2014, and in 2015 the Board will meet on February 9-10, May 11-12 and September 14-15. He invited Nalini Anand, director of the Center for Global Health Studies to provide an update on the CGHS activities.
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Update on the Center for Global Health Studies
Nalini Anand, Director CGHS, FIC
Ms. Anand reminded the Board that the mission of the Center is threefold:
- To establish a hub for project-based scholarship in global health science and policy;
- To provide a forum for international scientific dialogue and collaboration; and
- To provide a platform for short-term training.
Ms. Anand reviewed the timeline of activities of the Center through the end of the year. In January the Center sponsored a Prevention of Mother-to-Child Transmission (PMTCT) network meeting in South Africa. Another is scheduled in October in Washington. A symposium on brain disorders in LMICs was held in February, followed by a two-day writers' retreat to begin to articulate priorities in areas related to brain disorders. In April the second in a series of publications on research ethics was released, and in about two weeks a report will be published in Globalization and Health that will cover the outcome of last summer's global tobacco control meeting. That meeting looked at the ten-year investment in tobacco control, as well as emerging research and capacity-building priorities for the future.
Ms. Anand noted that in June there will be a major program on Enhancing HIV/AIDS Platforms to Address NCDs involving seven federal agencies. It will be a holistic approach to identifying how to enhance HIV/AIDS research and improve the health care platforms for patients, including those with NCDs. Disease burden and epidemiology will be addressed, as will current treatment interventions, and there will be an attempt to identify research gaps and opportunities. And in September the product of the HIV-NCD comorbidities project (in collaboration with the Office of AIDS Research) will be published in JAIDS.
Finally there are two programs in the latter part of the year, one on prevention of childhood overweight and obesity in Latin America, to be held in October, and another on urbanization and health in collaboration with the Office of Disease Prevention and the New York Academy of Medicine that will take place in December. The former will focus on implementation science and how to move research results into policy and practice in the Latin American setting. There will be a two-day workshop with researchers, implementers, and policy makers.
Ms. Anand closed her comments by inviting the Board to consider a proposal to establish a scholar-in-residence program, which will be phased in beginning with an informal structure that can be tested in a step-by-step approach. Ultimately, the objectives of the program would be:
- To provide a collaborative environment for experts to further their global health scholarship;
- To enhance CGHS activities through additional intellectual leadership;
- To provide opportunities for other ICs to engage scholars around global health topics of interest; and
- To stimulate collaboration and communication across sectors and USG agencies.
Ms. Anand commented that initially the recruitment of scholars-in-residence would probably be mainly from the academic community, but there should later be opportunities for individuals from the private sector, NGOs, government agencies, and even eventually, from foreign sources.
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FIC Non-Communicable Diseases Program Concept
Maria Said, Program Officer, Division of International Training and Research, FIC
Dr. Said discussed non-communicable diseases (NCDs) and the proposed FIC integrated infectious disease/NCD program. NCDs are fatal to 36 million people annually and the number is expected to increase by 17% over the next ten years. Clearly they cause significant morbidity as well, and strain the resources of the existing health care system. Historically at the international level there has been a focus on reducing the burden of infectious diseases like HIV/AIDS, tuberculosis, and malaria. But there is an overlap between NCDs and infectious diseases that should be addressed, which leads to issues of integration. FIC has supported three main programs during the past ten years – ICOHRTA, NCD Millennium and NCD Lifespan which, after awarding over 60 grants, is now winding down its grant funding.
Dr. Said commented that, looking to the future, an ideal integrated program might include:
- Commitment to the real needs of the patients and community;
- Integration of a holistic approach;
- A catalytic approach that would encourage leverage of resources, and synergism that would multiply results;
- Incentives for collaboration, and networking;
- An environment that would encourage leveraging both human capital and existing infrastructure, and encourage capacity building;
- Improved research opportunities for those already qualified in the field;
- The ability to respond to special needs and opportunities;
- Flexibility that would allow institutions, communities and countries to create supportive programs; and
- Sustainability.
Dr. Said noted that, in gathering information and recommendations from a wide variety of sources, it became clear that the present systems were in multiple silos yet scattered in approach and emphasis, involving many disciplines and diseases, and there was not a solid research base from which a training philosophy could be developed. There was agreement that the whole process needed coherence.
One approach suggested was to develop a program around risk factors, such as obesity, from which many NCDs arise. Another was to base a program on populations, such as migrants, or life progression time segments, like neonates or the elderly. But these seemed too narrow and prescriptive. An alternative suggestion was to approach the issue through consolidation, identifying broad existing platforms and infrastructures, and looking for links to the research community. That approach would be to identify research that could be leveraged so that there would be benefits to research in both NCDs and infectious diseases. The program should not limit incentives since research needs vary from place to place, and it should take advantage of already existing platforms, like the well-developed HIV/AIDS research infrastructure.
There are research opportunities that exist at the nexus of infectious disease and NCDs – the two do not always exist separately. There are aspects of each that are shared – chronic care, research methodologies, grants management are examples. There are fields that have been plowed by previous programs, such as the work already done in the HIV/AIDS field – surveillance, diagnosis, studies on stigma and poverty – that could be helpful to those involved in research in other areas. Dr. Said emphasized that there are opportunities that did not exist in the recent past, such as new technologies and new training ideas (MOOCs, for example).
Dr. Said concluded her comments by noting that, in a time of diminishing resources, an integrated approach is both responsible and reasonable.
Discussion
Dr. Holmes expressed appreciation for the thoughtful integrative model described in the presentation, noting that a holistic, patient-centered approach was commendable, but observed that the predominant theme in the discussion was about specific diseases. He added that NIH, for example, has a disease-specific structure in its various institutes and centers, which is fairly entrenched philosophically. There are, however, other models, such as the Kaiser Permanente health system that help communities build ways to be more responsible for their own health care. He encouraged FIC to consider the chronic disease model and integrated health systems, and how that might play into the LMICs, which mainly have non-integrated health care systems.
Dr. Merson expressed the opinion that chronic diseases, taken as a whole, are not amenable to an integrated health care approach, and to impose that concept on researchers in the program under consideration might force them to become more theoretical than realistic in the way they structure their grant applications.
Dr. Barry agreed that the integrative approach might discourage innovative thinking by applicants, since they may be more concerned about linking programs than "disruptive", but potentially creative, thought. Dr. El Sadr commented that the integration proposed might be a research question to be addressed. She added that it might be a selective process where integration of screening works, but integration of delivery of services may not work as well.
Dr. Tierney observed that health care in the U.S. is best provided by collaboration between generalists and specialists, who effectively use the same infrastructure. It is an integrated system with common leadership, information flow, workflow, and so on.
Dr. Glass closed the discussion, expressing appreciation for Dr. Said's excellent presentation. He introduced the next agenda item, a look back at the first four years of MEPI, noting that several of the MEPI PIs were present.
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Medical Education Partnership Initiative (MEPI) 4-Year Update
Myatt Htoo Razak, Program Director, Division of International Training and Research, FIC
Dr. Razak introduced four principal investigators from the MEPI program – Dr. Emilia Noormahomed (Mozambique), Dr. Peter Donkor (Ghana), Dr. James Hakim (Zimbabwe), and Dr. Milliard Derbew (Ethiopia).
Dr. Hakim made a brief presentation. Speaking on behalf of the 12 countries involved in the MEPI program, which includes 13 grants, Dr. Hakim noted the primary mission of MEPI: to increase the number of health care workers, to improve the quality of medical training, to improve retention, and to encourage and strengthen relevant medical research. In some of the MEPI countries there are consortia made of one MEPI university grantee working with one to five collaborating universities. During the four years MEPI has been in existence, the number of residents has increased and they have shown interest in a number of specialties offered by the MEPI schools, as well as in basic science.
Dr. Hakim stated that all of the schools have developed a robust faculty development program, and most have begun to develop opportunities for obtaining higher degrees. The overall improvement in training has given students more confidence and a better feeling for working in the local environments, including in the rural areas. In the area of research, Fogarty plays an important role through linked awards in specialty areas such as neurology, cardiovascular disease and mental health. All of the MEPI schools have established mentoring programs for young researchers, and there is a significant information and communications technology program.
Partnerships have developed with U.S. schools, some of the better-resourced African schools, and ministries of health and education. They are involved with faculty development, research methodology and administration, and mentoring. Dr. Hakim added that, as successful as the MEPI program has been, there are still challenges – more faculty is needed, and the ICT programs need more nurturing.
Discussion
Dr. Glass invited discussion. He commented on Dr. Donkor's efforts to provide emergency room support to patients who receive half of their medical care in the ER. He has taken advantage of that entry point to begin screening for HIV/AIDS and hypertension. Dr. Donkor agreed that the ER provided a platform for accessing patients with various issues. He added that there has been an effort to train emergency physicians in Ghana, as well as emergency room nurses, who become engaged in research in HIV, diabetes, hypertension and other disorders that often may be revealed in an ER visit.
Dr. Koroshetz observed that the number of MEPI physicians and nurses is relatively small in comparison to the number of problems that exist, and it may be necessary to consider building a care system around the MEPI presence. Dr. Kolars agreed, noting that the MEPI approach has been one of systems where the PIs are developing partnerships and taking a systems approach to dealing with their needs. Some of those partnerships have been with the ministries of health and education. There have also been contributions from some of the local governments.
Dr. Holmes mentioned the University of Washington's WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) model. The University's medical school is the only such institution in the five states, an area that includes 30% of the US, and is larger than some African countries. It is mainly rural, as in Africa. Dr. Holmes noted that the University of Nairobi has worked to get medical students out into the rural areas, where 16 health centers have been added to the partnership. Finally, he expressed concern that medical students there, when they complete their internships and work for a year, are expected to finance their own subspecialty education. He felt there should be some way to help these new physicians, perhaps by financing some of their residency requirements.
There was a brief discussion of the issues related to providing a level of basic care that should be provided, not by specialty-trained physicians, but by nurses and other clinicians who have been trained to provide those basic services and to understand when to refer patients to physicians.
Dr. Pablos-Mendez observed that funding in general had leveled out for global health, and PEPFAR funding on which MEPI relies has actually declined, although there has been an increase in support from some of the African countries that are experiencing economic growth. MEPI is fortunate to be in a position to benefit from that factor. Dr. Kaplan noted that the objective of increasing the number of quality adjusted life years is affected by medical care, much of that increase comes from outside the health care system. Dr. El-Sadr commented that MEPI is a major factor in responding to the lack of physicians, and NEPI is a significant contributor to increasing the number of nurses as well as nursing skill levels. The NEPI program is just beginning to build the infrastructure and resources that will be important to increasing the nurse and nurse midwife resources needed for the future.
With regard to growth, Dr. Derbew noted that, in Ethiopia, the number of medical schools has increased from 5 to 33 and enrolment has quadrupled to about 3,000. The main focus now is improving the quality of the medical students across the board. There has also been an increase in focus on research, which has been evidenced by increased interest in research by faculty. MEPI provides incentives in the form of five locally relevant research awards. There is also a program in emergency obstetrics and in surgical training to produce nurse practitioners.
Concerning continuing funding support, Dr. Morrison commented that it is important to consider how to package success stories that will inspire funders in countries inside and outside of Africa. The stories should encourage commitments within the African countries that result in matching funding, and demonstrate that the core goals of the AIDS-free generation challenge are being addressed by the programs in the African countries.
At the conclusion of the discussion Dr. Razak commented that there are many MEPI success stories and there is an effort to develop those stories and make them available to those concerned.
Dr. Glass invited Dr. Flora Katz to introduce the discussion of implementation science.
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Implementation Science
Dr. Flora Katz, Acting Director, Division of International Training and Research, FIC
Dr. Katz stated that NIH had published a definition of implementation science:
Research to identify, understand, and overcome barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines, as well as understanding circumstances that create a need to "de-implement" or reduce the use of strategies and procedures that are not evidence-based, have been prematurely widely adopted, or are harmful or wasteful.
Implementation science is an integral part of Goal 3 of the FIC strategic plan:
- Expand investment in research and research training in integration science across programs
- Catalyze interaction between researchers, policymakers and program implementers to promote uptake of evidence into global health policy and practice.
Dr. Katz commented that FIC was an early adopter of the concept in the 2001 ICHORTA program, which included this language in the FOA: encourage the development of evidence-based interventions appropriate to local circumstances, determine how best to generalize this, study factors, such as economics and many others, that will influence the effectiveness of interventions in a real-world setting.
An example of the kind of project that would be amenable to implementation science was a project in Hungary, where a third of the population smoked and where there were no restrictive laws concerning tobacco use. The goal was to reduce smoking and related cancers. The study involved 11 research components and the investigators maintained a liaison with the Ministry of Health throughout the project. The primary outcome was the passage of restrictive anti-smoking legislation in 2011, mainly based on the data and conclusions of the study.
A second project was described as "assessment-driven translational research." The goal of the study, conducted in Russia, where alcohol consumption is very high, was to prevent fetal alcohol syndrome and other developmental brain-related disorders in newborns. The process was to develop educational materials based on evidence-based interventions and to encourage a follow-up random controlled trial of a brief physician intervention of at-risk women.
A third example was a program to improve care cascade in Kenya through implementation science training at the largest teaching and referral hospital in Kenya, Kenyatta National Hospital, to improve HIV testing, linkage to care, ART initiation and adherence, and retention in care. The study approach was to provide a one-year certificate training program in health metrics.
The last example was a training program in an innovative process for implementable new products that would insert consideration of practical implementation at the outset, applying a metric to all potential products in the hope of eliminating those that would probably not be implementable in the end.
Dr. Katz invited Mark Miller to comment on the activities of his division, The Division of International Epidemiology and Population Studies.
Dr. Mark Miller, Director, Division of International Epidemiology and Population Studies, FIC
Dr. Miller explained that his division has historically concentrated on the interface of biomedical research and social science research at NIH, and how the two areas might produce pragmatic results. The approach is to try to quantify the technical, political and economic factors so that a formula for systematic review of an area can be achieved.
An example of a project is the division's Multinational Influenza Seasonal Mortality Study (MISMS), which was established to detect disease burden, relying on vital statistics data associated with circulating influenza viruses, fairly well understood in temperate zones, less understood in tropical settings. There was collaboration with researchers around the world, looking at tropical flu outbreaks, related chronic diseases and transmission patterns to try to develop prevention strategies.
A second example is related to implementing a product developed at NIH that otherwise might not have come to market. The product was Vi-conjugate vaccine, a typhoid vaccine, the result of a successful clinical trial at NICHD. Working with FDA and WHO, with support from the Gates Foundation, the drug was licensed and is being manufactured by several companies.
Ms. Nalini Anand, Director, Division of International Science Policy, Planning and Evaluation, FIC
Ms. Anand reiterated the third goal in the FIC strategic plan, to support research and research training in implementation science, which originally had the additional wording, to expand investment in research and research training in implementation science across programs. New wording was added: To catalyze interaction between researchers, policymakers, and program implementers to promote uptake of evidence into global health policy and practice.
Optimal uptake of implementation science will require interaction and collaboration in the scientific community. The goal is to enable the translation of evidence into policy and programs and to ensure that research is country-relevant and responsive to the evolving local context. There are three players in the process – scientists, policy makers and program implementers – and at times, an individual may wear more than one of those hats.
Ms. Anand offered one example of a technology that is mature enough for implementation, but has been slow to take hold, PMTCT, the implementable intervention to reduce transmission to neonates of HIV through breastfeeding. NICHD, with support from OGAC, was charged with the responsibility of forming a network of the three key players – researchers, program implementers and policy makers – to meet several times during the life of the grant. The network will identify case studies of successful and unsuccessful implementation, especially of PMTCT. Hopefully the network can begin to answer some questions:
- What are the key methodological barriers to utilizing science evidence to inform policy?
- What are the critical junctures at which researchers can most effectively inform the policymaking process, particularly as it is continually evolving?
- What are the minimal criteria for determining scalability of research evidence?
- Can interim results inform policy, and when and how?
Dr. Glass invited Dr. Pablos-Mendez to comment about USAID's approach to implementation science.
Dr. Ariel Pablos-Mendez, Assistant Administrator for Global Health, USAID
Dr. Pablos-Mendez stated that USAID has been involved with implementation research and delivery science (IRDS) for a number of years. IRDS is the foundation for introducing and sustaining effective health programs, a goal that is common to most of the agencies associated with global health. President Obama has committed the United States to achieving a vision of eradicating extreme poverty. Part of that vision includes saving the world's children from preventable deaths, reducing the incidence of AIDS, and achieving an AIDS-free generation. There is also a commitment to address preventable maternal deaths. In June 2012, the governments of Ethiopia, India, and the US, in conjunction with UNICEF, launched the Child Survival: Call to Action. It initially challenged the world to reduce child mortality to 20 or fewer child deaths per 1,000 live births in every country by 2035.
Dr. Pablos-Mendez commented that, with regard to IRDS, solutions are often known – it is just a matter of doing what you know. Traditionally the knowledge enterprise was about basic science, generation of knowledge, and dissemination of knowledge. Years ago that was through journals, often not accessible to much of the world. The Internet changed that. The knowledge enterprise has expanded to include knowledge management and knowledge translation and, of course, implementation science.
Describing the value chain theory that articulates a timeline, and the steps and resources required to bring a new technology product to the market. Dr. Pablos-Mendez related it to the evolution of chlorhexidine from its original use as a mouth wash to a prophylactic treatment that has effectively reduced mortality in newborns. It came out of an NIH proof of principle study in Nepal, and concomitant product development in Nepal, Bangladesh and Pakistan. The USAID Grand Challenges program funded a national scale-up, further helped by the endorsement of the UN Commodity Commission. It is now being distributed in 24 priority countries.
Finally, Dr. Pablos-Mendez commented that USAID launched the U.S. Global Development Lab, which has as a significant mission fostering implementation science that will include scaling up the availability of chlorhexidine in the 24 countries, and projects related to mobile health, especially with regard to preventable child and neonatal deaths.
Dr. Sameh El Saharty, Senior Health Policy Specialist, South Asia Region, World Bank
Dr. El Saharty discussed the Word Bank's approach to implementation science, noting that when Jim Kim became president of the World Bank, he named "delivery science" as a high priority – identifying data and evidence on what works and what does not work in product and service delivery. Dr. El Saharty explained that the Bank defines a client's needs and develops a plan that best fits their local conditions. That plan should identify best practices, best fit for the client's circumstances, and a feedback process to facilitate mid-course corrections as the plan is executed. Since much of the existing evidence and data is based on high resource settings, the challenge is to adapt the evidence to the economics of the client, and that process may take some time. The challenges that implementers face include the fact that successful pilot programs often fail to transition to full scale when real world factors intervene. There is also inadequate documentation of the process so that analysis of results is not possible. Perhaps the most important factor in implementation is the local adaptation of the intervention. A plan can go awry when it does not allow for the politics and the unique constraints that apply locally.
Implementation research and delivery science (IRDS) is useful in achieving the best results in an intervention because it offers the opportunity to develop new analytical tools and uses of evidence. IRDS enhances the potential for overcoming the pilot-to-scale issues and the effects of dealing with low resource environments.
Dr. El Saharty explained that the World Bank is undergoing a significant organization change, transitioning from a regional organizational structure to a more global environment. The Development Economics and Chief Economist Office will measure outcomes of the delivery process, rationalize delivery variations, assess the impact of government reforms and policies, and finally design innovative schemes to improve delivery. The Bank receives a large number of trust fund projects from clients, as well as project-funded research requirements. The latter produces a number of reports and "just-in-time policy notes" that are useful to policy makers and program implementers – all of which influence program implementation.
There is a program cycle that begins with identification of the program requirements, followed by implementation and monitoring, then project completion and finally evaluation. What is now needed is a feedback loop to enable mid-course corrections. That requires an evidence-based approach to program design and implementation, flexibility to make changes as the program proceeds, and a culture of learning in the process.
Dr. El Saharty concluded his comments by describing the collaboration with USAID and WHO to conduct a series of consultations on IRDS, to bring together policy makers, program implementers, funders, academics and researchers to work with clients to become more responsive to the client's needs.
Dr. Glass invited discussion.
Discussion
Dr. Holmes suggested that consideration of definitions might be appropriate. He noted that the following terms had been mentioned during the meeting: implementation research, implementation science, delivery science and program science. Dr. El Saharty suggested that providing solutions to the problem might transcend the need for definitions. He suggested a general definition could be to provide evidence-based solutions to the client, along with tools to get the job done, monitor the results and learn from those results.
Dr. Pablos-Mendez commented that the Global Development Lab had drawn from government, academic institutions and the private sector to establish a sounding board for proposals and projects. It will be available for consideration of outside projects, and one of the first recommendations was the scale-up of the availability of chlorhexidine to prevent neonatal death. Dr. Glass suggested that the MEPI network might be appropriate as a research resource on implementation of chlorhexidine. Dr. Pablos-Mendez commented that USAID has opted for "local solutions," moving funding directly to local recipients. The idea is to begin to ingrain research and development locally. Dr. El Saharty echoed the concept, noting that almost all World Bank research activities are in partnership with local partners. Usually there are three stakeholders – the funders, the decision makers, and the research entities.
Dr. Donkor commented that MEPI is in sync with the concepts of USAID and the Bank, and that all research and teaching is locally focused. Dr. Kolars commented that the research institutions may not have been as relevant to the activities described as they should be. He suggested there should be a way to increase MEPI's relevance to the whole process. Dr. El Saharty commented that the Bank's experience has been that clients do not perceive research as an important part of their solution, and there should be an effort to bridge that gap. Dr. Donkor observed that the Bank typically responds to the needs of governments.
Dr. Mensah commented that, considering the discussion about MEPI's relationships with USAID and the World Bank, it might be appropriate to think about those three parties, with the addition of interested NIH ICs that might develop initiatives that would be relevant to all four parties. On a previously discussed topic, he added that there are interventions that could apply not only to the LMICs, but anywhere. For example, the control rates for hypertension in the U.S. in women are about 55%. Kaiser Permanente in Northern California has demonstrated an intervention that can drive that rate to 80% in seven years. The hypertension control rate in Ghana is 10%. Similar interventions might improve control rates in both countries.
Dr. Glass commented that some of the best innovations come out of engineering schools. He asked if there are technical apps that could be developed there, tested in the MEPI environment, and moved through the implementation science agenda at Fogarty. Dr. Sasiskharan agreed that med-tech apps could, and they might even work in the social media space. An innovative incubator was mentioned that costs about $50 and runs on batteries – versus the usual $50,000 version currently in use. The research team is struggling with scale-up. Dr. Pablos-Mendez recommended submitting such ideas to the Grand Challenges.
Dr. Kaplan commented that Fogarty has demonstrated its skill in coordinating projects across the boundaries of the ICs. Of the 27 ICs, 16 have implementation science programs, but there is little coordination. He added that the National Center for Advancing Translational Science (NCATS) may be least involved. That area might be a fruitful Fogarty endeavor.
Dr. Holmes commented that chlorhexidine took ten years to come to fruition as a viable treatment, and there are estimates that it takes 15-17 years to bring a new idea from discovery to the point where policy decisions are being made. He felt that was too long. Part of the issue may be that USAID and the World Bank work with one set of clients, and NIH works with another. If the parties could keep talking, Fogarty might be able to facilitate a more streamlined process. Secondly, the time for new technologies to make it through the federal approval process has caused a decline in the number of technologies to reach approval, partly because of the requirement for comparative effectiveness studies. Dr. Holmes felt that was another issue that could be addressed by FIC.
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Adjournment
Dr. Glass brought the meeting to a close and expressed his appreciation to Drs. Pablos-Mendez and El Saharty for bringing a different perspective to the discussions, and he thanked the MEPI PIs for their participation.
The meeting adjourned at 3:25 p.m.
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