The Cura Project Institute, with the participation of important health stakeholders, celebrates the success of the 2nd Cura Talks, held on March 15 at the InterContinental Hotel in São Paulo. The event, which attracted a diverse audience, in person and online, was an important channel to discuss the advances and challenges of clinical research in oncology in Brazil.

The topic “Regulatory paths of clinical research in Brazil” highlighted the understanding of the paths of Bill 6007/23 and its consequences in clinical research. Since Brazil has made significant progress in this regard, the purpose of the event was to seek to understand and encourage an environment that is more conducive to the development of clinical studies and access to new therapies.

During the 2nd Cura Talks, experts highlighted the importance of clear and agile ethical regulations that promote the safety of study participants and optimize the approval process for new therapies. In addition, the need for tax incentives and adequate funding to boost clinical research in the country was highlighted.

The event also provided a valuable space for the exchange of experiences between researchers, health professionals, lawyers, patients, and support networks, highlighting the fundamental role of multidisciplinary collaboration in the advancement of clinical research in oncology.

The opening of the 2nd Cura Talks was held by the President of the Cura Project Institute, Fernanda Schwyter, who mentioned that:

“In this 2nd Cura Talks we will understand the changes that will take place in the field of clinical research, after the approval of Bill 6007/23 for all diseases, not just cancer, and after approval, we will be able to organize ourselves to implement actions necessary for the proper development of clinical trials and guarantee the rights of research patients.”

The importance of clinical research

With an introductory approach to the 2nd Cura Talks, Dr. Carlos Barrios, Director and Principal Researcher of the Oncology Research Center at PUCRS São Lucas Hospital, covered a discussion about the importance of clinical research and its impact on patients. Dr. Barrios emphasized that clinical research is an activity that involves multiple dimensions, including scientific advances, development of new drugs, social impact, and improvements in health services. He emphasized that institutions with research centers tend to offer better care to all patients, not just study participants, due to improved routines and the development of best practices.

Two examples were shared to illustrate the benefits of clinical research. He highlighted that clinical research has the potential to reduce disparities in medical care internationally and offer access to state-of-the-art treatments, regardless of geographical location. In addition, he emphasized the importance of increasing the number of research centers and funding for regional research that addresses the specific needs of local populations.

Dr. Barrios concluded by reinforcing the idea that clinical research is a fundamental activity that directly benefits patients, promoting hope and offering access to innovative treatments. He emphasized the need to continue working to expand the reach of clinical research and ensure that it is accessible to all who need it.

The next steps for implementing Bill 6007/23

Congressman Pedro Westphalen, obstetrician and Federal Representative, participated in the event as rapporteur of the bill that deals with clinical research on human beings in Brazil (PL 6007/23). He highlighted the importance of this project to streamline clinical research in the country, allowing patients to have faster access to innovative treatments. The project aims to unblock red tape and guarantee the quality and safety of research, allowing Brazil to become a research hub of excellence.

The congressman emphasized the urgency of the project, stressing that patients do not have time to wait for state bureaucracy. He emphasized the need to sensitize the Senate to the importance of the project and to guarantee its approval and presidential sanction. He also explained that, once approved and sanctioned, the law will be valid immediately and regardless of political changes in the government. He also answered questions about the regulation of the project after its approval, stating that the government must implement it without delay.

With regard to regulations, Westphalen advocates that the CEP/CONEP system be directly linked to the Ministry of Health. Regarding the administrative steps after the approval of the law, the Deputy emphasized the importance of pressure and mobilization of society to ensure its effective and rapid implementation. He highlighted the willingness to discuss possible adjustments to the project, as long as they do not mischaracterize its main purpose.

Finally, Westphalen thanked the opportunity to participate in the event and made himself available to collaborate with the project, highlighting the importance of the Cura Institute and the engagement of all those involved in the promotion of clinical research in Brazil.

Stories that inspire Cura

The mother of a clinical research patient, Alessandra Santos, shared her experience during the 2nd Cura Talks. Her daughter began to show symptoms, complaining of pain in her left thigh, which soon became disabling. After going through three hospitals and several treatments without success, she was admitted and diagnosed with a condition related to rectocolitis, an inflammatory bowel disease. Later, she participated in a clinical study, her daughter's life changed for the better.

She now lives a normal life, with minimal side effects from treatment. Alessandra expressed her gratitude for the study and emphasized the importance of publicizing clinical research. She recognized that while there is no cure for rectocolitis, proper care and treatment are essential. Alessandra also highlighted the need to support families during the clinical research process. She encouraged others to seek clinical studies and emphasized the importance of being informed about treatment options. His message highlighted gratitude for the opportunity to participate in the event and share his story, highlighting the importance of clinical studies in improving health and in the search for effective treatments.

Papo Cura

Papo Cura during the 2nd Cura Talks was a debate between Luana Ferreira Lima, Dr. Angela Kung, Dr. Carlos Barrios and the audience present and online, mediated by Fernanda Schwyter. The discussion addressed topics such as research, regulation, and the participation of society in this process.

The introduction highlighted the importance of understanding and absorbing the information presented. Dr. Barrios was invited to talk about the relationship between international research and research carried out in Brazil, while Dr. Angela Kung, a specialist in health law and member of the CEP/CONEP system, brought her expertise on the subject. Luana Ferreira Lima, representative of civil society organizations, TJCC (All Together Against Cancer) also participated, bringing the patients' perspective and the need to include them in the research process.

It was clarified that research is not only carried out by pharmaceutical industries, but also by academic institutions and researchers and the importance of including patients in the decision-making process. A study by Dr. Heloisa Resende was mentioned, revealing that a minimum percentage of cancer patients are invited to participate in research by doctors, pointing out the need for awareness in this regard.

Sponsors: Latin American Cooperative Oncology Group - LACOG, DAIICHI Sankyo Brazil and MSD.
Support: ABRACRO, ABRALE, Oncology Observatory and All Together Against Cancer, Overcoming Cancer and Life Time.

The full recording of the 2nd Cura Talks is available for viewing on the YouTube channel:

https://www.youtube.com/watch?v=4EtyifKKOQE

For more information about the Cura Project Institute, visit the official website: https://projetocura.org/
The Cura Project Institute will remain committed to promoting dialogue, education, and progress toward a more informed and engaged society. We look forward to having everyone's continued participation and support in our future initiatives.

Finally, the Cura Project Institute would like to express its sincere gratitude to the speakers, moderators, the Cura Team, and to the audience present and online, whose engagement and support were essential for the success of the 2nd Cura Talks. In addition, Cura records thanks to sponsors and support partners, whose support was fundamental to making this event possible.