During this 4-week programme, initiated by the Breast International Group (BIG) and the Latin American Cooperative Oncology Group (LACOG), and developed in close collaboration with the European Organization for Research and Treatment of Cancer(EORTC), the group attended a variety of activities (presentations, interactive exercises, classroom courses, site visits, etc.). They had the opportunity to exchange experience, know-how and ideas about the management of clinical research groups, as well as the negotiation, set-up and running of clinical trials. The European Centre for Clinical Research Training (ECCRT) and Institut Jules Bordet (IJB) also contributed to their training.

Objectives of the training programme

• Help medical and radiation oncologists active in academic collaborative groups in Latin America to deepen their knowledge of the key aspects of developing, launching and conducting international clinical trials as well as group management;

• Provide mentoring support to participants after their return to their home countries so that they can contribute to the strengthening of the clinical trials infrastructure and expertise within their groups; and

• Stimulate future research collaboration, within and between the Latin American cancer research groups, and in international organisations such as the BIG.  

Overview of topics covered during the 4-week training programme

At the EORTC, the trainees focused on the various aspects of clinical research development, from operational and technical issues to statistics. 

At BIG, the focus shifted more to communications and networking between collaborative groups, as well as fundraising.   

Courses on legal basics and team leadership were provided by ECCRT. 

Finally, a visit was also organized to Institut Jules Bordet (IJB), in particular the Clinical Trials Support Unit (CTSU)/BrEAST Data Centre, as well as the Breast Cancer Translational Research Laboratory.

The following provides more detail about the topics that were covered at info sessions and workshops that took place:

• Legal European framework: fundamentals for non-EU collaborators, pharmacovigilance, protocol development;

• Implementing the various countries’ regulations (from different parts of the world) into one protocol, translational research, imaging, medical perspective;

• Data management: protocol review, CRF and database design, data collection, tracking and status metrics, data review, final validation;

• Statistics: phase III design and endpoints, randomisation, data analysis. Phase II studies. Trial monitoring, diagnostic studies (imaging or TR), adaptive designs, HRQOL studies, publication policy, pitfalls in reporting, data sharing policy, budgeting;

• Site feasibility & selection, operational planning and set-up;

• Quality management, audit & inspections, procedures, legal basics & contracts;

• Overview of the translational research aspects of clinical trials;

• Fundraising and communications to the lay public, with examples from recent BIG initiatives;

• Communications within the BIG Network: BIG clinical trials development, including presentations at BIG meetings, to group/site feasibility process, and improving processes through the Operational Working Group;

• Communications within the BIG Network: public relations & communications tools, including the use of social media, dealing with the media and crisis communications;

• “BIG Music Night” at Grand-Place in Brussels: operatic musical celebration of the 20th anniversary of the idea to create BIG - in the presence of Her Majesty Queen Mathilde from Belgium;

• Visit to Institut Jules Bordet data centre (CTSU and BrEAST), which has run some of BIG’s largest adjuvant trials (e.g., HERA, ALTTO and APHINITY), to learn about its organisation and facilities;

• Visit to Breast Cancer Translational Research Lab (BCTL), for slide cutting from FFPE blocks, gene expression profiling technology-Affymetrix-, DNA and RNA extraction kits, cryostat for cutting frozen blocks, biobanking, and circulating tumour cells isolation technology (CellSearch).

A mentorship programme is also being developed to provide continuous support and advice to each of the trainees upon their return home. 

When asked for their opinion on this month-long training programme, the participants reported that they were eager to go back to their home countries to set in place different tools, introduce new techniques and methods, and further build on the strengthening of the relationship with BIG, within Latin America and with BIG’s global member groups.

BIG affiliated cancer research groups from Latin America

• GAICO - Grupo Argentino de Investigación Clínica en Oncología

• GBECAM - Brazilian Breast Cancer Study Group 

• GECOPERU - Grupo de Estudios Clinicos Oncologicos Peruano

• GOCCHI - Chilean Cooperative Group for Oncologic Research

• GOCUR - Grupo Oncológico Cooperativo Uruguayo

• LACOG - Latin American Cooperative Oncology Group