9/5/2024

The importance of the law to regulate clinical research in Brazil

The Cura Project Institute has been active in defense of the benefits of clinical research for the entire health system in Brazil and the need to expand patients' access to clinical studies. For almost 10 years, we have supported the funding of 11 researches, on different types of tumors.

In recent months, we have been attentive to understanding and enlightening the population about important points of Bill 6007/23, which will regulate clinical research in Brazil, since rights and obligations are guaranteed in our country, through laws.

In the midst of challenges, we share the approval of Bill 6007/2023, a framework for the regulation of research in Brazil.

In Brazil, laws are the foundation that underpins our rights and duties. And when it comes to science and research, regulation is fundamental to ensure safe and ethical advances.

The recent milestone approval of Bill 6007/2023 is an example of this. This Law is essential for the regulation of clinical research in our country, establishing clear guidelines and protecting both participants and researchers.

In this path towards approval, the role of the Cura Project Institute was fundamental, as it led efforts to implement it and clarified the important points of the bill and, through approaches to Social Networks, interventions with government agencies and events such as Cura Talks — Regulatory Pathways of Clinical Research in Brazil, which took place on March 15 in São Paulo (Event link: https://www.youtube.com/watch?v=4EtyifKKOQE&t=4981s). In this process, Cura has also demonstrated its commitment to ensuring that patients have equitable access to clinical research opportunities.

We strongly defend that “Research saves lives”. For this reason, it is essential to have legislation that guarantees rights and duties in the area of scientific research in Brazil, guaranteeing the safety, ethics, and quality of the studies carried out.

The Cura Project Institute plays an important role in defending patients' access to clinical research in oncology in Brazil. For almost 10 years, Cura has stood out for its dedication to promoting an ethical and accessible culture of clinical research, and to the awareness and education of civil society, informing about their benefits for the health system, how they drive medical innovation and have the potential to transform lives.

Points that highlight how laws play a fundamental role in the regulation of clinical research in Brazil:

Participant protection: Regulation through laws establishes clear guidelines to ensure the safety and well-being of clinical trial participants. This includes informed consent protocols, monitoring for adverse events, and guarantees that participants are treated with dignity and respect.

Ethics in research: The laws provide an ethical framework to guide the conduct of clinical research. They define ethical and moral standards that researchers must follow, ensuring that research is conducted in a fair, transparent manner, and with scientific integrity.

Quality of studies: Regulation through laws helps ensure the quality of clinical studies, establishing standards for study design, data collection and analysis, and dissemination of results. This contributes to the reliability and credibility of the research carried out in the country.

Promotion of innovation: By providing a stable and predictable regulatory environment, laws can attract investment and collaboration, driving advances in the area of health.

International alignment: The laws that regulate clinical research in Brazil can ensure that the country is aligned with international standards of good clinical practice. This facilitates collaboration with foreign researchers and institutions, promoting knowledge exchange and participation in multicenter studies.

Public trust: Robust and transparent legislation increases public trust in clinical research. By knowing that research is conducted according to ethical and legal standards, individuals may feel more comfortable participating in clinical studies and supporting science as a whole.

We are now facing a new chapter, where the regulation of clinical research will be anchored in a law. We will closely monitor this process and continue to promote information and awareness of civil society, through our actions, events and campaigns, with the purpose of a culture of ethical and responsible science in our country and, especially, demonstrating the commitment of the Cura Project Institute to responsible science and to the well-being of all.

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