Clinical Trials in Latin America: A Virtual Summit Agenda

SESSION 1: 10:00 a.m. – 10:15 a.m. Introduction and Explanation of How a Virtual Conference Works
SESSION 2: 10:15 a.m. – 11:00 a.m.

The Top 5 Latin-American Countries for Clinical Trials: Understanding Regulations in Brazil, Argentina, Mexico, Peru and Chile

Elizabeth Fernandes, Associate Lawyer, Bioethics, Biotechnology and Environment, BKBG Attorneys at Law

The number of clinical trials in Latin American countries has increased substantially. Countries such as Brazil, Mexico, Argentina, Chile and Peru offer many advantages to the industry. For example, they offer a large number of untapped research subjects, a capable work force, well-functioning health systems and reduced costs. There is ample value in conducting clinical trials in Latin America. The first and most important step to develop successful clinical trials in Latin America is to understand and recognize countries’ individual regulations.

Attendees will:

  • Delve into the key clinical trial regulations in Brazil, Argentina, Mexico, Peru and Chile
  • Understand why variations in regulatory procedures within each of these countries should be monitored closely
  • Discover the characteristics of research and ethics committees, including the role they play in their respective countries and what it means for both sponsors and sites
  • Be provided strategies to monitor the latest updates and learn how to create a Latin American regulatory strategy

11:00 a.m. – 11:30 a.m.

Break
SESSION 3: 11:30 a.m. – 12:15 P.m.

The Tipping Point:  Ethical Challenges in Conducting Clinical Trials in Countries With Fewer Healthcare Resources — An Alternative to Medical Care?

Pedro Garbes-Netto, MD, MSc, Regional Director of Clinical Development, Latin America, Sanofi Pasteur

Conducting clinical trials in low health resourced countries poses real challenges when determining the differences between healthcare and clinical development. Regulators are increasingly concerned about dual ethics standards when conducting trials in developing countries. One example has been the oncology setting in which the standard care in control groups for several lung cancer trials offers much better care than those offered by public health systems throughout Latin America. Although clinical trial settings are separated from healthcare in most developed countries with clinical research activities, in Latin America these settings live side by side.

Attendees will:

  • Examine where the tipping point lies between providing healthcare and conducting clinical research
  • Identify the major regulatory and health policy players involved in Latin American clinical trials and the roles they play
  • Explore the necessary steps to create and conduct ethical clinical trials in Latin America that deliver results
SESSION 4: 12:15 p.m. – 1:00 p.m.

Using Internal and External Resources to Develop Efficient Site Selection Teams

Oscar Garcia, Dir. Clinical Research, Sanofi-Aventis

Choosing which sites will enroll the required number of patients on time and on budget is crucial to the success of clinical trials.  Sponsors need to build teams of varied skill sets that can properly vet and select trial sites. Drawing the required talents from multiple departments is important to assure all study requirements are met. Once sites are selecte comprehensive planning strategies are necessary to assure sites are functioning according to study protocols and regulatory guidelines.

Attendees will:

  • Discover the roles and responsibilities of each person who is part of the site selection team and what key success factors and performance indicators measure success
  • Opportunities for collaboration with other organizations for strategic site-allocation planning
  • Developing strategies for selection, training and improvement through metrics according to productivity, quality and compliance
1:00 p.m. – 2:00 p.m. Lunch Break
SESSION 5: 2:00 p.m. – 2:45 p.m.

Preparing Clinical Trial Sites — Vetting Everything From Couriers to Labs to Translation Services

Edilson Uiechi, Clinical Research Associate, Novartis Biociencias S.A.

Clinical trial sites in Latin America present challenges related to the cultures, languages and previous or lack of experience with clinical research. The most important piece of appropriate site selection, laboratories and couriers is to understand key strategies that produce high-quality and trustworthy clinical research results.

Attendees will:

  • Understand regional challenges and differences in working with translations and validation of documents and understand the requirements for both the importation and exportation processes
  • Learn to choose central labs and couriers depending on the amount of adequate resources to support different languages and requirements, timelines, services and their qualifications
  • Select appropriate sites and understand the importance of a thorough review by conducting site selection visits and reviewing both new and experienced sites

2:45 p.m. – 3:15 p.m.

Break

SESSION 6: 3:15 p.m. – 4:00 p.m.

Working With Investigators: Approaches to Strengthen the Sponsor-Investigator Relationship

Tatiana Vogel, Independent Consultant, Clinical Research Partners Ltd., Chile, Former Associate Director Clinical Research Operations for Latin America and Research Director, Chile, Merck

This session will focus on how sponsors must remain sensible to the challenges investigators face to build a stronger sponsor-investigator commitment and increase performance.

Attendees will:

  • Set the formal and explicit setting of expectations in terms of recruitment timelines, figures, data management and time availability to manage expectations with investigators
  • Learn how to deal with the instructions and procedures of the CRA on duty that are dependent on their criteria and proficiency level
  • Understand how to apply with the current model of conduct of International Clinical Trials while managing multiple contacts from CROs and sponsors

SESSION 7: 4:00 p.m. – 4:45 p.m.

Successfully Working With IRBs and Regulatory Authorities to Prevent Clinical Trial Delays

Michele Barabash, Associate Director, Clinical Project Manager, Pfizer

Institutional Review Boards (IRBs) and regulatory authorities can be described as both exciting to work with and downright depressing. Building a productive relationship is paramount to successful Latin American clinical trials. Trial delays can take many forms, but putting in the work upfront with IRBs and regulatory bodies pays important dividends down the road.

Attendees will:

  • Discover the top three delays that affect most trials
  • Uncover best practices to assure mutual respect exists between the sponsor, their representatives and IRBs
  • Learn seven tips for getting IRB relationships back on track if things go awry