After graduating from the school of nursing in 2013, Patricia started at Hospital das Clínicas da Universidade de São Paulo in Brazil as a registered nurse. Over the years, she has gained a wealth of knowledge and expertise, and has actively participated in the coordination of complex and large-scale clinical studies.
Patricia Momoyo Zitelli (right) with Prof. Flair J. Carrilho at the 5th CHANCE Investigator Meeting in Vienna, Austria. Picture: © European Foundation for the Study of Chronic Liver Failure.
You are a member of the team in Hospital das Clínicas that participates in the CHANCE study, how do you contribute to this project?
It is my great pleasure and honor to participate in a global and large-scale study. Our institution is the largest healthcare center in Latin America and is the most active liver clinic and transplantation center in Brazil, which makes possible the recruitment of patients for this and future studies. My specific task is the coordination of the team. This includes organization of the logistics recruitment around the clock, upload of data and train people to correctly process and store samples.
Although our team has a limited number of persons, efficient task management, with a schedule of well-planned activities helps us to hold the top position in the patient recruitment dashboard since February 2022.
Soon after we launched our campaign to accelerate patient recruitment in the CHANCE study, your team recruited patient no. 500. What was the importance for you to receive a free registration to attend the EASL Congress 2023?
I really appreciated the invitation to join the team that runs this study that will define the role of liver transplantation for [acute-chronic liver failure] ACLF patients. Participating in the EASL Congress, the 5th CHANCE Investigator Meeting and the EF CLIF General Assembly was an excellent opportunity for networking and to see the efforts of people around the world contributing to the success of the study. At the EASL Congress, I had the opportunity to attend the presentation of the new EASL guideline on ACLF by Prof. Richard Moreau and to participate in sections dedicated to nurses.
Hospital das Clínicas had a very active role in the ACLARA study. How your participation in the ACLARA study impacted your career?
In 2017, I was invited by Prof. Alberto Farias to participate in the ACLARA study. I realized the huge responsibility I had as study coordinator of the regional office that was set in São Paulo. I was in charge of running the activities of one of the biggest studies sponsored by EF CLIF outside Europe, and providing assistance to the coordination of the 44 centers across 7 Latin American countries within the ACLARA Consortium. Then, I decided to complete and MSc in Gastroenterology and MBA in Project Management. This helped us to be competitive and to work better.
What are your plans for the future?
Our team has gained much experience with the ACLARA and CHANCE studies sponsored by the EF CLIF and with other European and North American international initiatives. I expect to continue expanding our network, participate in projects related to improving current knowledge on liver diseases, patient care and healthcare service provision, and get involved in community education and raise awareness on liver diseases.
What advice would you give to someone starting out a career as a clinical study coordinator?
Investing in people's motivation is paramount to success in any project. The development of some skills helps push the career of a clinical study coordinator. This includes excellent interpersonal relationships, especially with the principal investigators and all members of the team, ethical work practice, attention to detail, and critical thinking. Liaising with sponsors, central office, investigators, and other study team members is critical to ensure that all aspects of the study are running according to protocol and adhere with regulatory guidelines. Overseeing uploaded data, quality control procedures, and providing training and support are core responsibilities.
From my point of view, one of the challenges is joining a motivated team and dedicating time to training, if possible, having education in project management is a good beginning.
The CHANCE study is promoted by EF CLIF.
About the CHANCE study
CHANCE is a multicenter, global, observational study designed to assess the benefit of liver transplantation in patients with acute-on-chronic liver failure (ACLF) grade 2 or grade 3. This study counts with the support of the International Liver Transplantation Society (ILTS) and the European Liver and Intestine Transplant Association (ELITA) to recruit 2000 patients in 80 centers in 27 countries around the world. The primary objective of the CHANCE study is to compare 1-year graft and patient survival rates after liver transplantation in patients with ACLF grade 2 or grade 3 at the time of liver transplantation with patients with decompensation of cirrhosis without ACLF-2 or 3 and transplant-free survival of patients with ACLF-2 or 3 not listed for liver transplantation. The international nature of this study will allow for deep assessments of the potential impact of different precipitating factors of ACLF (e.g., alcohol vs. Hepatitis B virus flare), different types of liver transplantation (deceased donor vs. living donor liver transplantation) and different regional and national allocation systems on transplant outcomes. Beside these clinical objectives, the CHANCE study aims to build a repository of biological samples to explore new biomarkers to predict prognosis on the waiting list and after liver transplantation, and mechanisms of liver and extrahepatic organ recovery.
ClinicalTrials.gov Identifier: NCT04613921