May 20th, 2020 – Today is the International Day of Clinical Research. Such date, instituted to raise awareness of the civil society regarding the importance of clinical researches, is celebrated during the most severe health emergency of the recent history.
Due to the pandemics of the new corona virus, there is a global effort, with unprecedent velocity, to discover vaccination, drugs and diagnoses to contribute to neutralize the effects of the pandemics. Science takes center stage and will certainly become stronger after this sad episode.
In Brazil, however, we still have a long way to go before we achieve the international standards in the development of clinical researches. According to the paper “The importance of Clinical Researches for Brazil”, published in 2019 by INTERFARMA (Association of the Pharmaceutical Industry of Research), while Brazil is among the ten ranking positions of global population, GNP and pharmaceutical market, it occupies the 24th position in terms of participation in clinical studies, which represents a loss of seven positions in ten years. The two therapeutic areas most studied in the world, according to that entity, are Oncology and the Central Nervous System (SNC); in conjunct they represent 42% of all studies launched in 2018.
According to the Director of LACOG (Latin American Cooperative Oncology Group), oncologist Dr. Carlos Barrios, there are approximately 70 thousand studies being carried out in world involving cancer patients, with the purpose of testing different treatments. Approximately 45% are carried out in the United States, 25% in Europe and only 2% in Latin America.
The oncologist lists several barriers impairing the development of researches in Brazil: insufficient resources, bureaucracy at the public sector, need of additional research centers and lack of information of the population regarding the importance of clinical researches.
Along the recent years there is an increasing concern among the regulatory and ethical authorities to accelerate the approval span of protocols so that the deadlines in Brazil become more aligned with those of other countries, emphasizes Barrios. The Bill 7082/17, which brings new regulations to the area, is also being discussed in the Chamber of Deputies.
According to the oncologist, due to the Covid-19, Conep (National Commission for Ethics in Research) has shown that greater agility in issuing opinions is possible. The agency installed video cameras for online sessions and approved 253 experiments until May 11, in record time.
Another relevant aspect, according to the oncologist, is the lack of information. “When people understand the importance of research, they want to participate in the process,” he says. According to him, only a minority fails to sign the consent form, a document that contains information about everything that will occur in the clinical study. “This demonstrates that the informed patient is someone who collaborates because he/she feels that the process is something positive for him/her”.
According to Dr. Barrios, the Cure Project has a great mission, which is to generate knowledge in the civil society about the importance of research. “May the citizen be proud to say that he/she participated in a research project”, he concludes.