FACTORS RELATED TO THE COMPETITIVENESS OF THE COUNTRIES BRAZIL, ESTONIA AND MALAYSIA IN ATTRACTING GLOBAL CLINICAL TRIALS

Ricardo Eccard da Silva*, Angélica Amorim Amato, Dirce Bellezi Guilhem, Marta Rodrigues de Carvalho and Maria Rita Carvalho Garbi Novaes

ABSTRACT

Introduction: Investment in infrastructure for undertaking research is important for holding quality clinical trials and attracting global studies to countries. Estonia and Malaysia are regions which are investing in the clinical research sector and are among the five countries with the highest rates of average relative annual growth of actively recruiting research centers. In Brazil, the National Clinical Research Network in teaching hospitals has been created. These institutions’ research centers are planned for the undertaking of clinical trials of interest to the Unified Health System (SUS). Objective: to analyze the prevalent illnesses, active pharmaceutical ingredients (APIs) under investigation, and the population studied by gender, age range and clinical indication studied, in Brazil, Estonia and Malaysia. Methods: The data were collected from two databases: i) the Clinical Research Control System (SCPC) of the Brazilian Health Regulatory Agency (Anvisa) and ii) the International Clinical Trials Registry Platform / World Health Organization (ICTRP/WHO). Data were selected from intervention studies with APIs, while observational studies and intervention studies with products for health were excluded. Results: Among the three countries investigated, the chronic illnesses are studied most. However, in Brazil, E11 Non-insulin-dependent diabetes mellitus, B18.2 Chronic viral hepatitis C and C50 Malignant neoplasm of breast are studied most. In Malaysia and Estonia there were no studies involving C50 Malignant neoplasm of breast and B18.2 Chronic viral hepatitis C. On the other hand, psychiatric illnesses such as F20 Schizophrenia and F33.9 Recurrent depressive disorder, unspecified, proportionally, were studied more in Malaysia and Estonia than in Brazil. In Malaysia, malaria was studied in the lower age range populations, such as children, preschool children and infants. The APIs studied most in the SCPC (2009 to 2012) belong to the class L01X Other Antineoplastic Agents and L04A Immunosuppressants, according to the Anatomical Therapeutic and Chemical (ATC) classification. The large majority of APIs studied in the clinical trials of the ICTRP do not have an Anatomical, Therapeutic and Chemical code, which may indicate that many of these APIs are new and have not yet been placed within this classification. In second place, one finds the APIs classified as L01X Other Antineoplastic agents, followed by L04A Immunosuppressants. Conclusion: Comparing Brazil, Estonia and Malaysia, it may be ascertained that there are no substantial differences in the profile of the clinical trials. The attracting of global clinical trials to countries such as Malaysia and Estonia may, among other factors, be related to the efficiency in the assessment of research projects by the regulatory body. Furthermore, the development of new drugs for the pediatric population is not a priority for the pharmaceutical industries and other research institutions.

Keywords: research infrastructure; clinical site; global clinical trials.