Quali-quantitative synthesis of the global panorama of clinical trials on leprosy

Abstract

The work presents the analysis and synthesis of clinical trials about leprosy worldwide in the last 20 years. Three technological aspects for study were defined, namely: diagnosis, drug/treatment and vaccine. Seventy-one (71) clinical trials were identified (11 for diagnosis, 54 for drug and 6 for vaccine), distributed among 62 main sponsors, 70 secondary sponsors and 21 countries, with 14 countries participating in 7 international consortia. For the recovery of clinical trials, the ICTRP^® platform of the World Health Organization was used. Through quantitative and qualitative analysis and synthesis, a pattern of similarity was observed between 6 types of indicators highlighted in the figurative elements of the article. Eighteen types of final results (3 genera and 18 species) and 9 phases of clinical development were mapped. The most significant participation of non-hegemonic nations was found, which corroborates and validates the state of the art on the investment dedicated to the diseases of neglected populations. A temporal prospecting of two decades was adopted, although records were only identified in 15 years. In this time cut, 9 inflection points were identified, which demonstrates an oscillating development agenda, which presupposes an inconstant interest of the hegemonic pharmaceutical industry in favor of the struggle against leprosy that devastate neglected populations. It is concluded that the clinical effort aimed at leprosy is "corrective", because "treatment" has the most significant amount of clinical trials, and in the background is the "preventive" clinical effort, which represent the subquantities related to the categories "vaccine” and “diagnosis”. Therefore, it appears that the quali-quantitative analysis and synthesis allows us to assert that the clinical development scenario dedicated to leprosy deserves special attention from the State and other real factors of power, in order to create more effective public policies in favor of the neglected populations affected by leprosy. In summary, it is suggested that new public policies shall be created to encourage synergy between clinical trials, both national and international, in order to induce a safe path to clinical-therapeutic independence and, consequently, better performance in the struggle against leprosy in Brazil.