American Society of Hematology

Join Store Job Center Foundation My Account

Home >
Global >

NCI-ASH Hematology Clinical Trials Workshop

The Office of Latin American Cancer Program Development of the US National Cancer Institute (NCI) and the American Society of Hematology (ASH) are pleased to announce the first NCI-ASH Hematology Clinical Trials Workshop, a one-day event for early-career clinical investigators in Latin America. Participation in this prestigious workshop is by application only, and hematologists are encouraged to apply as soon as possible. The NCI-ASH Hematology Clinical Trials Workshop will be held May 13, 2009, from 8:00 a.m. - 5:30 p.m. in São Paulo, Brazil. The workshop will be held in English and will be offered at no cost to the selected participants; however, participants are responsible for paying for their own travel and housing.

Participants will gain an appreciation of clinical trial design and conduct based on a curriculum adapted to address needs specific to Latin America from some of the most prominent Latin American investigators in the field of hematology. This workshop is also an opportunity to encourage research collaborations between and among Latin American hematologists who would like to become involved in clinical trials and to promote clinical cancer research and training for a new generation of clinicians, physicians, and investigators to address hematologic malignancy issues.

Topics to be covered include:

Selecting the Hematology Research Team for Clinical Trials
Participants will gain a broad understanding of the roles of the hematology research team in Latin America, including the principal investigator, team leaders/research associates, clinical research nurse(s), data management team, and support staff. Discussions will also include financial considerations and challenges faced when building a research team. An extended question and answer period will allow participants to ask the moderators to address their specific concerns.
Formulating a Research Concept and Developing a Protocol
Participants will learn how to prepare research concepts and develop clinical trial protocols based on hypothesis-driven questions specific to Latin American populations.
Challenges and Triumphs in Implementing Clinical Trials
Experienced clinical researchers will share the specific challenges they faced when implementing clinical trials in Latin America, including data ownership, statistical and data analysis, and intellectual property issues.
Considerations for Developing an Implementation Plan
This session will provide participants with an overview of critical elements in an implementation plan, including:
- Data and safety management
- Bioethical issues
- Data safety and monitoring committee - roles and responsibilities
- Regulatory compliance in Latin America
- Business practices in different Latin American institutions
- Policies and regulations in biospecimen shipping nationally and internationally
Panel Discussion of Clinical Trial Concepts
Workshop participants will be asked to come to this session with specific questions related to clinical trial design and implementation in Latin America. Session moderators will be on hand to address the questions and/or provide additional information.
Networking Lunch
A one-hour lunch will allow participants an opportunity to get to know each other and discuss their ideas for clinical research.

Eligibility and Application Process

Clinicians, physicians, scientists, biostatisticians, or molecular biologists throughout Latin America are encouraged to apply. The workshop is designed for investigators who have had some experience with clinical trials, (e.g. worked with enrolled patients), but who have not advanced into designing and implementing their own studies.

To apply, complete and submit an application via fax (+1 202 776 0545) or e-mail (nci-ashworkshop@hematology.org). In the application, please describe your hematology experience, your previous involvement in clinical trials, and your career experience and goals.

Since attendance for this workshop is very limited to allow for close interaction with faculty, we encourage you to submit your application as soon as possible, but no later than Friday, April 30, 2009. Applications will be reviewed weekly, and participants will be notified of their acceptance within seven business days.

Schedule

7:30	Breakfast Available
8:00	Welcome and Opening Remarks Nancy Berliner, MD and Jorge Gomez, MD, PhD
8:15	Session I: Selecting the Hematology Research Team Moderator: Linda Burns, MD Faculty: Raul Ribeiro, MD, and David Gomez Almaguer, MD This session will provide a broad overview of the roles of the hematology research team in Latin America, including the principal investigator, team leaders/research associates, clinical research nurse(s), data management team, support staff, and financial considerations. Participants will also lean about the challenges faced when building a research team, and have ample opportunity to ask questions.
9:45	Coffee Break
10:15	Session II: Formulating a Research Concept and Developing a Protocol Moderator: Bob Löwenberg, MD Faculty: Francesco Lo Coco, MD, Miguel Sanz, MD, and Martin Tallman, MD This session will help participants formulate research concepts and develop protocols for clinical trials based on hypothesis-driven questions.
12:15	Networking Lunch
13:15	Session III: Challenges and Triumphs in Implementing Clinical Trials Moderator: Eduardo Rego, MD Faculty: Guillermo Ruiz‐Argüelles, MD, FACP, FRCP, Lem Martinez, MD, and Martin Tallman, MD Participants will hear about specific challenges faced in implementing a Latin American clinical trial from national coordinators and other members of the International Consortium on Acute Promyelocytic Leukemia. Topics will include data ownership, final data analysis, and authorship issues.
15:15	Coffee Break
15:30	Session IV: Considerations for Developing an Implementation Plan Faculty: Jorge Gomez, MD, PhD This session will provide participants with an overview of the implementation plan, including: Data and safety management Bioethical issues Auditing plan for starting and stopping the trial Regulatory compliance in Latin America Business practices in different Latin American institutions Rules and regulations in shipping human specimens internationally
16:15	Session V: Moderated Discussion of Clinical Trial Concepts Moderators: Nancy Berliner, MD, and Jorge Gomez, MD, PhD Workshop participants are asked to come to this session with specific questions related to the design and implementation of clinical trials in Latin America.
17:15	Closing Remarks