Partnerships Latin America Session Spotlight: Meet the Demands and Expectations for Patients in Latin American Trials: Ethical Challenges to Consider

Each week leading up to Partnerships in Clinical Trials Latin America, we'll be highlighting a session from the upcoming conference. It will take place August 2-4, 2010, in Buenos Aires, Argentina. For more information, visit our webpage to download the brochure.

Featured Session: Meet the Demands and Expectations for Patients in Latin American Trials: Ethical Challenges to Consider

Presented by:
Luis Pliego, MD, Regional Medical Affairs and Regulatory Manager, JANSSEN AND CILAG – ARGENTINA
Daniel Ciriano, Medical Director, ROCHE – ARGENTINA
Ana Rodriguez Castelli, MD, Clinical Research Manager PIERRE-FABRE – ARGENTINA

About the session:
Regulatory authorities in Latin America may approve a drug that patients may not be able to access due to lack of coverage – a serious consideration for sponsors contemplating marketing a
drug in the region. For patients participating in clinical trials, law dictates in that trial sponsors must continue to provide drugs to those in need even after the trial ends which is a huge cost factor for sponsors. These are critical ethical concerns, as is informed consent translating into risks to sponsors of trials in Latin America that must be fully considered.

• Formularies/Access – how does reimbursement impact a sponsor’s decision to conduct a trial and/or commercialize a product in the region?
• Language barriers and informed consent – are these documents easily understood by study participants?
• Post-Study Drug Provisions – must pharmaceutical companies be able and willing to market drugs in the countries in which the patients are enrolled in trials?