6

Institutional Arrangements for Research and Development

International research on cardiovascular disease (CVD) has a history of four decades or more and includes the CVD Unit of the World Health Organization (WHO), the International Society and Federation of Cardiology (ISFC) with its scientific councils and Section on Epidemiology and Prevention, and specific efforts initiated in several developed countries over the same period. International collaboration has been encouraged by the ISFC's sponsorship of the International Conferences on Preventive Cardiology (ICPC) every four years. These were held in Moscow in 1985; Washington, D.C., in 1989; Oslo in 1993; and most recently, Montreal in 1997. The growing participation of developing country scientists—reaching more than 400 of the nearly 3,000 registrants in 1997—demonstrates a widening recognition of the global dimensions of CVD. This recognition has led to a growing number of collaborations between institutions in developed countries and developing countries.

In addition to WHO and ISFC, national and international organizations engaged in CVD prevention and control include the International Clinical Epidemiology Network (INCLEN); United Nations Scientific, Educational and Cultural Organization (UNESCO); national and regional foundations; national academies of science and medicine in developed and in developing countries; medical schools and other academic centers of excellence; the World Bank; and donor agencies such as the Canadian International Development Centre and Swedish International Development Agency. Also, several networks have been established for the conduct of multinational randomized clinical trials in CVD, such as the International Studies of Infarct Survival (ISIS), Long Term Intervention with Pravastatin in Ischemic Disease (LIPID), and Global Utilization of



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6 Institutional Arrangements for Research and Development International research on cardiovascular disease (CVD) has a history of four decades or more and includes the CVD Unit of the World Health Organization (WHO), the International Society and Federation of Cardiology (ISFC) with its scientific councils and Section on Epidemiology and Prevention, and specific efforts initiated in several developed countries over the same period. International collaboration has been encouraged by the ISFC's sponsorship of the International Conferences on Preventive Cardiology (ICPC) every four years. These were held in Moscow in 1985; Washington, D.C., in 1989; Oslo in 1993; and most recently, Montreal in 1997. The growing participation of developing country scientists—reaching more than 400 of the nearly 3,000 registrants in 1997—demonstrates a widening recognition of the global dimensions of CVD. This recognition has led to a growing number of collaborations between institutions in developed countries and developing countries. In addition to WHO and ISFC, national and international organizations engaged in CVD prevention and control include the International Clinical Epidemiology Network (INCLEN); United Nations Scientific, Educational and Cultural Organization (UNESCO); national and regional foundations; national academies of science and medicine in developed and in developing countries; medical schools and other academic centers of excellence; the World Bank; and donor agencies such as the Canadian International Development Centre and Swedish International Development Agency. Also, several networks have been established for the conduct of multinational randomized clinical trials in CVD, such as the International Studies of Infarct Survival (ISIS), Long Term Intervention with Pravastatin in Ischemic Disease (LIPID), and Global Utilization of

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Streptokinase and t-PA (tissue plasminogen activator) for Occluded Coronary Arteries (GUSTO), among others. Research on CVD has gradually expanded through the International Ten-Day Seminars on the Epidemiology and Prevention of CVD, sponsored by the ISFC with participation from WHO; U.S. and other national programs; and other short courses. The submission of nearly 1,500 scientific abstracts for the fourth ICPC in Montreal demonstrates the growth in CVD research. Several developing countries now have a critical mass of qualified health professionals to meet the challenges of the global CVD epidemic. In many others, however, the trained scientists and infrastructure are too few to address already urgent tasks. It has become increasingly important to consider the organizational arrangements under which CVD prevention and control around the world can best be facilitated. This chapter outlines the need for appropriate institutional arrangements and identifies the functional requirements for achieving global CVD prevention and control. Based on these considerations and examples of successful models, the chapter concludes by proposing an immediate and long-term answer to the question, How can global R&D for cardiovascular health best be institutionalized? Formal institutional arrangements for R&D in cardiovascular health are important for three reasons: Many organizations and programs are engaged in activities relevant to CVD prevention and control. The impact of their work can be enhanced, and duplication avoided by effective exchange of information on CVD activities. Activities in new and existing programs can be strengthened through a central agency that provides communication, coordination, and technical and material support. A widely recognized central agency is needed to advocate for CVD prevention, to set R&D priorities, and to acquire and allocate resources to meet R&D priorities. EFFECTIVE RESEARCH AND DEVELOPMENT AT LOCAL OR NATIONAL, REGIONAL, AND GLOBAL LEVELS The immediate goal for cardiovascular R&D is to enhance local capacity through education and training; development of networks where appropriate; and conduct of local research that is comparable with other centers and applicable internationally. For activities in CVD prevention and control to be successful, it is essential that nonhealth sectors—for example, education, agriculture, industry, and environment—are also included in development of the program. Potential partnerships should be identified and integrated into the action plan.

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The major functions to be undertaken at different levels are as follows: Local or National: Develop and maintain the capacity and resources to plan, implement, and evaluate research and demonstration projects for CVD prevention. These should include: community-based assessment of the CVD burden; monitoring of and intervention in risk factors and their determinants; testing clinical interventions (e.g., EVP and algorithms for low-cost clinical care); and where feasible, investigating the local determinants of CVD risk. Regional: Support local or national centers as they undertake their activities providing: technical support; communication and exchange of information; funding support from regional and international donors; and evaluation of the status of CVD prevention activities in the region. Global: Support regional centers in the conduct of their activities: maintenance of global data on CVD prevention and control programs; dissemination of current data, protocols, guidelines, and literature on CVD prevention and control; and convening of advisory groups to assess global needs, evaluate current activities, and recommend additional activities if they are needed. MODELS OF INTERNATIONAL COLLABORATION International collaborations can be highly effective. Two of the most effective models are described here. The Special Programme for Research and Training in Tropical Diseases In 1975 the United Nation Development Programme (UNDP)—World Bank—WHO established a Special Programme for Research and Training in Tropical Diseases (TDR) to relieve the burden of tropical diseases around the world. In the 20 years since its establishment, TDR has been dramatically successful in its

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international partnerships, among the three cosponsoring agencies, with other organizations working in similar areas, and among the more than 5,000 scientists in 160 countries who collaborate in its activities. This model has several key characteristics: strong leadership; support of program staff; generous donations from cosponsors, bilateral development agencies, private foundations, and governments of some developing countries; emphasis on periodic performance evaluation; and management that emphasizes scientific priorities. The MONICA Project MONICA is the WHO Multinational Monitoring of Trends and Determinants in Cardiovascular Disease. This project complements the older cross-sectional studies of incidence of disease with additional longitudinal investigation of CVD determinants and outcomes. The MONICA project initiated the simultaneous monitoring of cardiovascular mortality, morbidity, case fatality, risk factor levels, and social and behavioral trends in defined communities. Over time these trends were used to identify causal relationships and interactions among variables. Because MONICA replicates the same core of observations in many different communities, the project is beyond the scope of any single research unit or national action. The model has accomplished the following favorable outcomes: a 10-year study in 60 countries in North America, Europe, and the former Soviet Union, along with Australia, New Zealand, China, Japan, and Malta; a common study protocol and centralized laboratory-electrocardiogram evaluation centers; a defined population for study within each center; census data defining each population by sex and age; population surveys at the beginning and end of the 10-year study period, which included at least 200 individuals in each 10-year age and sex group between ages 35 and 64; and collection of annual data on the use of health services by each population. Additional examples illustrating successful national and international collaborations are cited in the supplement of the Catalonia Declaration (CDC, 1997). Collectively these examples illustrate strong potential for CVD prevention and control if well organized.

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DEVELOPMENT OF AN INSTITUTIONAL MECHANISM FOR CARDIOVASCULAR RESEARCH AND DEVELOPMENT An institutional mechanism is required for a sustained, global R&D that supports efforts for CVD prevention and control. To ensure prompt attention to the urgent needs in this area, the committee recommends that a Steering Committee for Cardiovascular R&D be established immediately under the aegis of the Global Forum for Health Research. The functions of this committee would include, but not be limited to, the following: (1) establishment of a program for competitive grants and setting of priority areas modeled after the UNDP—World Bank—WHO Special Programme for Research and Training in Tropical Diseases; (2) establishment of a global network on CVD health policy; and (3) promotion of financial and technical exchange among researchers and agencies or ministries of science and technology in industrialized countries, industries, and others. The committee recommends that the activities of the steering committee be modeled after the TDR program with its broad range of participants that include scientists and donor agencies such as foundations, bilateral development agencies, and governments. Although the MONICA project is a strong model it was smaller, limited mainly to Europe and North America, lacked stable funding, and operated for a shorter term. For the longer term, the committee recommends that WHO assume the lead in promoting global CVD control, adopting a TDR-like mechanism for this purpose. This recommendation is consistent with the view of international experts who attended the Fourth International Conference on Preventive Cardiology at Montreal in June 1997. Participants noted that for more than 30 years, WHO, through its Cardiovascular Disease Unit, has played a critical role in addressing major issues of global prevention and treatment. Although this role has been seriously curtailed in the recent past, the committee has concluded that a renewed commitment to CVD control by WHO offers the best prospect for establishing the necessary infrastructure to ensure sustained R&D in support of CVD prevention and treatment worldwide. The two models proposed by the committee should seek to involve the professional component of cardiovascular medicine, which is currently organized globally into three intercontinental societies—European, Inter-American, and Asian Pacific—under the umbrella of the International Society and Federation of Cardiology. This existing network of national professional societies and foundations is composed essentially of volunteers. As such, it currently lacks the funding, substantive infrastructure, and managerial capacity to be a realistic alternative to the models proposed here. However, this network could assist in providing appropriate scientific consultation, project review, and even project oversight for the primary body chosen. Finally, it is worth noting that the Institute of Medicine in its recent publication America's Vital Interest in Global Health (IOM, 1997) defined ''global health" as health problems, issues, and concerns that transcend national bounda-

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ries and that may best be addressed by cooperative action. Thus, the United States and other developed countries—in partnership with developing countries and with international organizations, industry, academia, foundations, and other nongovernment entities—must lead from their strengths in medical science and technology to play a central role in global health (see Appendix A for further rationale). Partnerships among countries and agencies are a key element for the cost-effective and sustained R&D that is needed to support global CVD control.