An improvement in the purchasing power of the population and greater access to health treatments expands this potential and hence the need to carry out research in this population, such as: characterization studies of the population, observational studies, pharmacoeconomic studies and pharmacovigilance. According to a study in 2013 the consumption of Brazil’s middle class grew 13.6% compared to 2012. This represents 54% of the population is equivalent to a consumption of R $ 1.17 trillion, health being the second biggest expense this consumption (R $ 71.8 billion). If the Brazilian middle class represented a country would be the 12th most populous country in the world and the 18th nation to higher consumption in the world (2).
Following these strategy criteria for choosing the countries favorable return on investment and success of the project, Brazil is a relatively positive scenario, but not fully competitive with other emerging markets for clinical research.
A key factor in attracting research subjects and in estimating the inclusion rate is the availability of accurate information, recorded or otherwise documented, particularly as regards the incidence and prevalence. This information is indispensable for planning a project and are an important tool in the decision making of the sponsors. Investment material and human resources, time, knowledge and technology will be taken only to places where previously there availability and accuracy of two different initial information.
The Department of the Unified Health System (DATASUS) provides a database where you can find information on the proportion of hospital admissions in SUS by large groups of diseases. This database can be used as an initial and partial tool for mapping and planning of research subjects pickup availability in different locations in Brazil (3).
Currently, some diseases and medical specialties have a fuller information system. An example of this evolution in the creation of national databases came up with the launch of the National Oncological Care Policy (PnAO) in 2005 and the creation of Oncology Care Network. This project has the protagonist action of the National Cancer Institute (INCA) and with the direct and indirect interest of the Federal Government, the State and Municipal Health Departments, universities, health services, research centers, not organizations government and society in general. This action together from different sectors allowed a data source based on the information obtained from cancer registries derived mainly from Population-Based Cancer Registries (RCBP), supervised by the INCA / MS, and the Mortality Information System (SIM) , the Ministry of Health, centralized nationally by the Department of Health Surveillance (SVS / MS). INCA since 1995, conducts and publishes cancer estimates for Brazil, taking into account the most frequent primary locations and disaggregating them by states and capitals. Disclosure of this information, since 2005, acquired biennial. This fact allows agile obtain quality information on the distribution, incidence and cancer mortality in Brazil (4) (5).
While digital inclusion indicates that in the future all medical and hospital care institutions will have a computerized service and a local database system, regional and national unfortunately this is not yet the reality in most medical specialties and institutions Brazilian health. More professional research centers and some hospitals already have computerized medical records in your routine, allowing the creation of a local database and a quick survey across information from individuals, disease and treatments.
Undoubtedly, the availability of this type of feature gives these institutions a competitive edge in research centers selection process, however there are still excellent seats of private hospitals data and health insurers that are underutilized. Many information diseases, treatments and costs are not used by many institutions themselves rather for lack of knowledge of how to use or handle such information.
As an auxiliary tool in mapping the availability of funding for research subjects, a parallel action can be accomplished through the use of database management subject research services (PMO – Patient Management Organization). These companies can offer own databases and identification service, screening and attracting volunteers according to the specifications of selection criteria and exclusion of a particular protocol. The Brazilian market still has potential for expansion of this sector because, unlike other countries, this service is still rarely offered and used in Brazil.
Brazil has, at least in its major cities, with the existence of reputable public and private research centers, which have an infrastructure of human and physical resources to meet the clinical requirements within their specialties. The infrastructure of support and logistics services is another factor that must be considered together, because this depends on the standard of excellence of the steps involved in carrying out the studies
The presence of local offices of the leading CROs and a reasonable network service providers involved in clinical research is an enabling factor for conducting multicenter studies in the country. In this respect Brazil, can take a differentiated and prominent position in Latin America, but the short supply of national central clinical laboratories certified and accredited, it produced a second difficulty for conducting clinical research in Brazil.
The logistics of sending samples to central laboratories, especially outside Brazil, is an item that demand special attention in terms of whether it is biological material that requires special care and enough agility to meet the deadlines established for a completed methodology of a protocol study. In a country with continental dimensions like Brazil, sending biological samples to central laboratories, even within the country, you need an air logistics infrastructure and specialized enough to meet this demand. The need for sending samples to central laboratories outside the country, even in some local studies, increases costs, deadlines and bureaucratic processes, and many of these tests could be performed in Brazil, if there was a greater supply of these services.
As for the quality criteria of the review system / approval of the local ethics and regulatory system agility, on the one hand the regulation of existence specifies is favorable and provides control, security and credibility to studies conducted in Brazil, on the other hand, the regulatory times are more cumbersome, which often precludes the participation of Brazil in international multicenter studies. In these studies, there is the need for simultaneous inclusion of patients in research centers all participants and this is not due exclusively to the product development time or competitive inclusion among research centers but also due to the scientific and statistical methodology that requires generating results that are simultaneously evaluated during the study go.
Undoubtedly the biggest bottleneck for conducting clinical research in Brazil, whether national or international, are still the deadlines for evaluation and regulatory approval, and bureaucratic difficulties for the import of investigational medicaments and donation of equipment to the institutions. However, some preventive measures can be taken in order to minimize such regulatory deadlines.
There are frequent disputes that can be prevented if the sponsor is flexible and has previous knowledge of these local requirements and its obligation to carry out the research in Brazil. Issues such as, methodological and scientific justification for the use of placebo; providing medication after the study (or the lack of scientific justification proven safety for the supply of study medication still not registered in the country); sending genetic material outside Brazil; clinical research safely with a legal representative in Brazil; Detailed description of the statistical design with an emphasis on methodology of randomization, blinding and calculation of sample size; distribution of condoms and contraceptive assistance during the study; service warranty during the study (including possible access to the ICU service), total treatment guarantees any sequelae or adverse events caused by the study; scientific justification for the absence of study in the country of origin sponsor, adequacy of the presentation of the study drug, among other issues, should be reviewed and discussed with the sponsor prior to submission of the study to local regulators.
Performing a prior analysis of the protocol by local experts can anticipate likely ethical and legal disputes. The regulatory dossier requires customization and explanations in accordance with local requirements and complexity of the study. No doubt this requires effort and higher initial attention by the sponsor, but may be more advantageous than the simple submission of standardized files that can generate doubts and disputes that will be responsible for further delays in the approval process as a whole. Predict in advance to clarify all possible questions minimizes unfavorable regulatory deadlines to be considered in the overall planning of the study.
This site review can reduce waiting times, for which more time is consumed in the regulatory process in Brazil is the time when we await the opinion of the regulatory agencies on responses to disputes generated during the course of the ethical evaluation and regulatory process. Clarification of the most critical and recurring points of this approval process already in the protocol and / or informed consent and / or dossier of trial documents, you can not solve, but shorten the long-term regulatory hold.
For a competitive insertion of any country in international clinical studies, it is necessary not only to full adherence to the principles of good clinical practice (GCP / ICH), but also the improvement and maintenance of specialized human resources. Other factors are important as an infrastructure that includes a growing demand, adequate costs with quality of service, speed in attracting and recruiting research subjects, reducing bureaucracy of the legal and contractual approvals from institutions and agility of ethical and regulatory system.
Conducting clinical trials in Brazil back benefits to the country such as access to new technologies necessary for development and health policies; scientific exchange among researchers; capacity building and training of human resources; job creation; investments; patient access to treatments for excellence and above all more precise information on the new drug in the local population; thus facilitating decision-making by regulatory agencies as the safety and efficacy required for the product to be registered in Brazil. Therefore, implementing the necessary improvements to the ethical and regulatory approval system has quality with agility is in the interest of society, the government, patients and all sectors involved whether private or public.