Conducting Clinical Trials in Resource-Limited Settings and Enrolling Vulnerable Subjects

Globalization is a core component of the business models of pharmaceutical companies, and includes the conduct of clinical trials. Major drivers are the anticipated lower costs of research, the large pool of (treatment naive) patients, expected lower regulatory investments, and access to emerging economies. This makes the conduct of clinical trials also in resource-limited settings attractive. However, the complexity of social and ethical issues of clinical research must not be underestimated and neglected. Predictable risks and burdens must be compared to foreseeable benefits for the participants or communities under investigation. This mandates any sponsor conducting trials in resource limited settings to come up with fair and practicable solutions. Sensitivity for cultural differences is key when interacting with local investigators, authorities, monitors, and study participants. Good local knowledge is needed to navigate the challenges of the regulatory landscape. Particularly in Africa, capacities and in rastructure must often be strengthened, and many achievements taken for granted in the Western research world may pose barriers in resource-limited settings.

This course will provide practical insights into the particular challenges and caveats of the conduct of clinical trials in resource-limited settings and involving vulnerable populations, and will provide hands-on solutions and approaches..

• Identify the ethical particularities and caveats of the enrollment of vulnerable subjects from resource-limited settings into clinical trials
• Identify the consequences and implications of the conduct of clinical trials in resource-limited countries or settings
• Address the basic issues when dealing with competent authorities in resource-limited countries
• Build a basis in understanding the potential operational and logistical challenges
• Recognize the limitations of GCP and its translation into clinical research under challenging circumstances
• Recognize the impact of cultural and religious factors on the conduct of clinical research
• Build knowledge on the informed consent procedures in trials involving subjects of various cultural backgrounds
• Meet the challenges of monitoring in resource-limited settings

• Clinical Research Professionals who are new to running clinical trials in resource-limited settings.

The course will be led by one of the following instructors:

Gabriele Pohlig, Ph.D.

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Day 1: 8:30 a.m. – 5:00 p.m.

• Introduction into Clinical Research in Resource-Limited Settings: Background; misconceptions; challenges
• Site Selection & Capacity Building: Strategies; means; solutions
• Working with Resource-Limited Competent Authorities: IECs; IRBs; regulatory authorities
• The Many Ethical Caveats of Resource-Limited Settings: Overview; guidelines; respectful approaches
• Informed Consent: Different cultural contexts; vulnerable populations; local languages

Day 2: 8:30 a.m. – 5:00 p.m.

• The Challenge of Safety Reporting: Creating awareness and understanding; dealing with different concepts
• Quality Management: No Compromises? GCP Implementation; monitoring; audits
• Monitoring in Difficult Settings: Special challenges; approaches and communication; the ideal monitor
• Data Capture & Management and Study Documentation & Archiving: Optimization for sites with poor infrastructure

• Group work; case studies; role plays; discussions

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-11-084-L01-P. Released 8/11.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.