Pharma emerging markets: clinical research management in Latin America
Carlos Pinzon and Valentina Jaramillo
Investigacion Clinica Latam
Technological advances and training of human resources in clinical research have made research a potential process of economic and intellectual growth in the past thirty years. Especially in developing countries, health research has undertaken a worldwide exponential increase, integrating medical care processes to research and perspectives focused on multidisciplinary working groups such as transnational research and biomedical research, among others.
For a much better understanding of disease mechanisms, diagnosis and prognosis the future of clinical management should be based on the topmost knowledge provided by the above mentioned technologies. It is also very likely that near future developed treatments are much more effective and have fewer side effects due to pharmacogenetics. The advent of these technologies, which now still seems far away, is likely to be relatively fast and Latin America is no different. Hence, health managers in the region must ensure they provide these technologies in a rational way, getting them distributed to great capacity institutions to generate knowledge.
“Especially in developing countries, health research has undertaken a worldwide exponential increase…”
On one hand, Biotechnology and Biomedicine research and innovation development will be subject to organizational forms adopted by the education and health system. On the other hand, its level of clinical management implementation will be subject to the way they converse with basic research institutions, with the University and adhere to the development of the Administration´s policies that favor planned growth.
At the hospital internal organization, innovative management models that enhance the entrepreneurial culture will encourage research and technological innovation. To ease development it is necessary to count on professional leaders with care, teaching, research, management and enterprise vision, placing them on the Administrative Staff of hospitals. These professional should take responsibility for medical, research, investment in new technologies and all types of economic decision making. These aspects shall derive from a cultural revolution in which the Administrative Staff brushes aside the idea that research, care and management are incompatible items and understand that only a joint and coordinated view of those areas will enable the development of high quality assistance. The Administrative Staff must understand that this joint and coordinated view is the only mechanism to achieve high quality assistance to control costs and allow the incorporation of new technologies. So one of the challenges for Latin America is the implementation of clinical management.
The Administrative Staff of university hospitals should lead teams that address all areas of activity of a hospital such as care, teaching, research and management. Thereby, they must comprehend that the rate of growth and development of knowledge make it difficult for an individual to be a healthcare, professor and biomedical research leader at once.
Nowadays, models from the 1950s, in which it was considered that doctors should be able to discover new biological and physio-pathological mechanisms and in turn apply scientific advances in the diagnosis and treatment of diseases of their own patients, seem to be over. Consequently, university hospital professionals must increasingly aim to develop preferentially in one of the areas without losing basic skills for the rest. If Latin America doesn´t want to be left behind, it is imperative to develop programs that capture and mobilize the talent or the implementation by the institutions of intra and extramural sabbaticals.
Quality research and innovation comes from structures based on high-level hospital care institutions, basic research centers and universities. To complete this collaboration model between major university hospitals, universities and basic research centers, the presence of a fourth element is required that is represented by the business sector. The knowledge transfer between local Latin America research institutions and leading multinational corporations in Biomedicine and Biotechnology fields will be a significant success factor in future development.
The supportive role of the administrative staff is crucial. In the first place, a planned investment is required because technological platforms for quality research entail significant investments. There must be a planning and development process in institutions that count on sufficient critical mass and the foundation for optimal employment. Hereafter, the administrative staff should realize that first level research structures must meet certain characteristics and articulate accreditation processes. A third important aspect is the development of more flexible legal frameworks that vary from current regulations and the consolidation of vigorous policies of business incentives that may favor the development of new technologies. Finally it is important to highlight the need of health systems for righteous, independent, capable and agile technology assessment and medical research agencies in their processes, course of action and evaluations with methodological rigor to avoid becoming a hindrance on technological development. The Agency for Health Care Research and Quality (AHQR) of the United States, the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom, the Swedish Council on Technology Assessment and Health Care of Sweden and the Alberta Heritage Foundation for Medical Research (AHFMR) in Canada are role models that Latin America should look up to.
“Quality research and innovation comes from structures based on high-level hospital care institutions, basic research centers and universities.“
The existence of these agencies in health systems is not incompatible with their creation in hospitals, mostly, innovative hospitals anticipate national health systems. Within major university hospitals an agency that promotes and evaluates new technologies can contribute to fostering technological innovation, evaluating received proposals and distributing them as necessary.
The constitution of these agencies seek to keep away from typical unbalanced situations in which technologically stagnant areas, on account of being integrated by professionals with little concern, coexist with innovative areas. As a result, not much discussed and precipitated health technology additions take place. These types of agencies can be comprised of organizational units to develop a comprehensive methodological support to researchers and physicians in general.
As we can see there is still work to do in Latin America but the region is on the right track.
The next piece in this series will be published at the beginning of August.
About the authors:
Carlos Pinzón is a Medical Doctor and Clinical Epidemiology Masters Candidate. He is Coordinator of the Cochrane Center in Colombia and Fundación Univeritaria Sanitas Research Institute. He can be contacted at firstname.lastname@example.org.
What do you think will propel Latin America ahead in the field of clinical research management?