CLINICAL TRIALS SCENARIO IN BRAZIL- STUDY AND SPONSOR PROFILES
Author(s)
Julian G1, Moreira Ed1, de Oliveira RW1, Francisco Fd2, Ruenis AP2
1Evidências - Kantar Health, São Paulo, Brazil, 2ABRACRO, São Paulo, Brazil
OBJECTIVES: Brazil is the largest country in South America, with more than 200 million inhabitants with multi-ethnic profile. Despite the large clinical research potential, data on clinical research profile in Brazil are currently scarce. Therefore, the objective of this study is to describe types of clinical trials and studies as well as sponsor profile in Brazil. METHODS: We analyzed data on studies conducted in Brazil in 2014 using two databases, namely ABRACRO (Brazilian Association of Contract Research Organizations) and ClinicalTrials.gov. ABRACRO database compiled data of 17 CROs in 2014. RESULTS: ABRACRO database included 627 clinical studies in 2014, 160 initiated that year and 467 ongoing, with 16,651 subjects. The most common sponsors were global pharmaceutical (300; 74.6%) and foreign biotech (39; 9.7%) companies, while national pharmaceutical companies and global pharmaceutical local affiliates sponsored 8.5% and 5.5% of the studies, respectively. Regarding development phase, the large majority of studies were phase III (432; 74.7%), followed by phase II (93; 15.7%); observational studies accounted only for 3.5% of the studies. ClinicalTrials.gov has data on 1684 studies conducted in Brazil in 2014, of which only 8.8% were observational; phase III trials also prevailed, comprising 54.6% of the classified studies. CONCLUSIONS: Global pharmaceutical and foreign biotech companies seem to be responsible for the majority of the clinical studies conducted in Brazil. The country has a great potential for recruitment, reflected by the number of phase III studies included in both databases. In spite of that, observational studies are rarely conducted, although being essential to obtain data on effectiveness, patient reported outcomes, epidemiology and pharmacoeconomy. Larger incentives from national pharma companies and local pharma affiliates may be an important way to increase and diversify local data generation in Brazil.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP235
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Health Care Research
Disease
Multiple Diseases