How clinical research evolves in Brazil | The ABRACRO

Clinical research has existed in the world since the 1930 decade. But in Brazil, the area only began to develop in the years 1970. At that time, a law required proof and efficacy by scientific means for the registration of medications.

Since then, with the emergence of the regulatory organs, much has changed. Regulation based on international standards has made the sector more aware of the increasingly stringent ethical issues. Although Brazil is the sixth largest pharmaceutical market, it occupies the 14th position in clinical research. That's because there are some obstacles that prevent this advance.

Regulatory barriers

In recent years, Brazil has been part of clinical studies that have enabled the development of innovative medicines in the area of oncology, hypertension, diseases related to the central nervous system (depression, schizophrenia, Alzheimer's disease, etc.), among others. However, one of the main obstacles to conducting clinical research in the country is the delay in the time of approval of studies, which puts Brazil behind countries such as Argentina and Chile in conducting clinical research.

The process of double ethical approval is one of the main offenders of the time indicator. After the analysis of the Coordinator and the Ethics and Research Committee (CEP) linked to a hospital or university where the study will be applied, the validation of the regulatory organs is still occurring.

Brazil often loses the deadline to start a study that will be held at the same time in several countries. The reason is often this delay. 

Bill

The scenario, however, is optimistic for the Abracro. There is a bill in evaluation that, after approved, intends to give more force to the sector, which today is governed only by norms and resolutions that do not have legal power.

 

Learn about the benefits for those involved in clinical research

 

Benefits of clinical studies in Brazil for local investigators

  • Stimulation and access to the use of new therapeutic options;
  • Technical and scientific improvement, through exchanges with scientists from other countries;
  • Financial reward for the quality of work, often reverted to the development of research centers, mainly in universities;
  • Development as "opinion leaders";

 

Benefits of clinical studies in Brazil for health professionals

  • Job Opportunity (specialists in clinical studies);
  • Training Opportunity (Science/methodology);
  • Exposure to international quality standards;
  • Financial reward/better wages;
  • Personal/professional development;

 

Benefits of clinical studies in Brazil for public health services

  • New funding sources;
  • Stimulus for modernization;
  • Update on quality methods and standards;
  • Better efficiency in operations (costs);
  • International label of "Excellence";

 

Benefits of clinical studies in Brazil for patients

  • More accurate diagnosis;
  • The best possible treatment ("State of the Art");
  • Greater nursing care/pharmacy;
  • Attention and more rigorous medical follow-up;
  • Access to untreated/undiagnosed patients;
  • Advantage with the inversion of the seasons;

 

Benefits of clinical studies in Brazil for the pharmaceutical industry

  • Access to highly motivated investigators;
  • Creation/development of "speakers";
  • Training of "opinion leaders";
  • Local data with new medications;
  • Copy protection;
  • Exploring the Brazilian market.

 

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