Volunteer Voices: International Clinical Trials Workshop and Joint Symposium Address Clinical Research in Latin America

Kara Garten
May 09, 2011 12:37 PM

International Clinical Trials Workshop and Joint Symposium Address Clinical Research in Latin America
By Lucía Delgado, MD and Eduardo Richardet, MD, PhD


Clinical research in Latin America is facing significant challenges. Although many of our countries have top quality investigators, well-equipped laboratories, and acceptable funding for basic and translational research, in regards to clinical, epidemiologic, and health system research, conditions are lacking in many areas. Related to clinical research, significant barriers such as insufficient funding, the low percentage of full-time and well-trained clinical researchers and current regulatory issues have result in very few clinical trials from Latin American researchers.

In an effort to overcome these challenges, the 3rd International Clinical Trials Workshop (ICTW) and the 1st Joint Symposium about barriers for clinical research were held in Punta del Este, Uruguay, March 24-26, in collaboration with the American Society of Clinical Oncology (ASCO), the Latin American Federation of Cancer Societies (FLASCA) and the NCI Office of Latin American Cancer Program Development (OLACPD), and chaired by the authors of this article.

The main objectives for the ICTW included:
- Learning how to conduct quality clinical research
- Discussing the roles and responsibilities of the research team
- Gaining a better understanding of regulatory processes
- Understanding the principles of ethics, informed consent, and patient safety

A group of 75 attended the workshop – primarily principle investigators, physicians, data managers, research nurses, and study coordinators. Based on their feedback, 80% indicated that they learned new skills to help them conduct quality research. A similar number indicated an increased understanding of regulatory practices and the importance of patient safety.

To illustrate the collaborative nature of the team, Ms. Carmen Jacobs was invited to participate in the ICTW to contribute her experiences as a research nurse. The empowerment of nurses to take a more important role in research was achieved through the involvement of nurses in the program. Seventy-three percent of attendees indicated an increased understanding of what roles each member of the research team has in conducting research, of which 17% were nurses.

The results of the participants’ final ICTW evaluation indicated that the course was a success. In fact, ninety-five percent agreed that the overall quality of the meeting was of a high standard. Interestingly, 71% considered that based on their participation in this meeting, they would change in some way their current practice or research. However, 40% also indicated that they would face challenges in making the desired changes. Most often listed were financial limitations, however other challenges include lack of human resources and training for researchers.

The  symposium was held the following day, March 26th, and focused specifically on academic clinical research. The main objectives of the Symposium were to review its current situation globally and in Latin American countries, to identify the main barriers for its development and to identify potential actions to improve overcome them. These activities were also sponsored by the Uruguayan Cooperative Oncology Group (GOCUR).

We are convinced that this ICTW and Joint Symposium will have a positive impact on the development of clinical cancer research in Latin America, necessary to develop evidence based treatment strategies appropriate to our emerging economies.

Carmen Jacobs: An oncology research nurse’s perspective

I have always been proud of being an oncology clinical trials research nurse. I have been a registered nurse for 15 years, and have been involved in clinical trials for the last 11 years. I am an oncology certified nurse and a certified clinical research professional. What I have enjoyed the most about my job is both taking care of my patients and the interdisciplinary aspect of managing the care of a patient that participates in a clinical trial.

Last Fall I was invited to participate in an International Clinical Trials Workshop that was going to take place in Uruguay. ASCO and NCI were sponsoring the workshop and had asked ONS for a Spanish speaking clinical trial nurse. I felt honored when I was chosen to be the ONS ambassador to such an important symposium.

I was pleasantly surprised by the enthusiasm and eagerness of the nurses to learn about clinical trials. But the biggest surprise was how well the physicians involved in clinical trials responded to the idea of a nurse as a valuable member of the clinical trials team. Some of the nurses told me how much they would like to have a more active role in the management of the clinical trials, but did not know if their physicians would understand the potential value of their contribution to the clinical trials team.

There is definitely much work to be done. The role of the nurse in South America is not the same as that of the United States. The educational preparation received by the South American nurses is very different from ours, and it will take a great effort to raise them to the same standard as the oncology and clinical trials nurses in the US. However, I do believe with the appropriate support and resources, it can be accomplished.

I can definitely say my experience in Uruguay was very satisfying. I felt proud of my profession and of my role in the clinical trials team. Most rewarding of all was the feeling that I brought hope to my fellow nurses of a bigger and greater role in the care of their patients.
 

Additional information about the ICTW
Topics were discussed among FLASCA, ASCO and NCI and included: “Overview of Cancer Issues in Latin America”, “Ethical Considerations”, “Sponsorship and Funding”, “Roles and Responsibilities of the Research Team”, “Clinical Trial Design and Methodology”, “Patient Accrual Strategies”, “Planning and Surviving an Audit”, “Regulatory Issues – International and Regional Perspective”, “Promoting Clinical Trials/Studies”, as well as a “Breakout Discussion Group Presentations”, “Intellectual Property & Technology Transfer Issues” and tips on “Publishing Research Findings”, among others.

Content was delivered through a combination of presentations and break-out sessions.

The Faculty included representatives from academy, regulatory authorities, ethics committees and sponsors, being some of the most distinguished professionals in the field:

From USA: Steve Grubbs, Jorge Gomez, Igor Espinoza-Delgado, Carmen Jacobs, Gary Kelloff, Dean Bajorin, Claudio Dansky-Ullman and Don Young.

From Peru: Carlos Vallejos and Henry Gómez.

From Chile: Jorge Madrid, Bettina Muller and Lucía Bronfman.

From Colombia: Andrés Cardona.

From Brazil: Nise Yamaguchi and Max Mano.

From Uruguay: Ignácio Musé, Enrique Barrios, Eduardo Osinaga, Lucía Delgado, Jorge Torres, Delia Sanchez, Omar Alonso, Mario Varangot, Gilberto Rios, Jorge Pignataro, Robinson Rodríguez, Mauricio Cuello, Rodrigo Fresco, Ana Pérez, Myriam Dibarboure, Gabriel Krygier, Aldo Quarnetti, Aida Rey, Pedro Kasdorf, Giselle Tomasso, Isabel Alonso, Graciela Sabini, Alvaro Huarte, Tabaré Vázquez.

From Argentina: Guadalupe Pallota, Elizabeth Mickiewicz, César Blajman, Eduardo Richardet, Eduardo Cuestas, Luis Fein, Guillermo Lerzo, Norma Picnic, Diego Kaen, Adrian Hannois, Martin Richardet, José Zarba, Santiago Bella, Bernardo Leone, Roberto Pradier, Ricardo Kirchuck.

There was a special lecture by Dr. Tabaré Vázquez (former President of Uruguay) on March 26, entitled “Public Politics to Encourage Scientific Research”. Taking advantage of this event, FLASCA handed him and health authorities, during the opening ceremony, a letter stating its full support in the trial with the tobacco industry.

The course was directed to all members of the clinical research team (principal investigators, research nurses, clinical trial coordinators, data managers, etc). In order to achieve this, participants were encouraged to register in research pairs, in other words, as a pair representing two different research specialties - such as a principal investigator and a data manager or nurse. A small number of participants were selected, in order to encourage interactive discussion.


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