30-Hour Design and Conduct of Clinical Trials: Requirements, Statistical Issues, and Clinical Protocols (Jun 06 - Aug 15, 2023 )

30-Hour Design and Conduct of Clinical Trials: Requirements, Statistical Issues, and Clinical Protocols is organized by Barnett International and will be held from Jun 06 - Aug 15, 2023.

Description:
Clinical trials play a pivotal role in evidence-based medicine. This 30-Hour Design and Conduct of Clinical Trials Program will provide important epidemiological and statistical principles necessary for designing clinical research studies. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, sample size determination, and statistical analysis issues. All aspects of the development and writing informed consent form and study protocol will be addressed, including criteria for the selection of participants, assignment of study treatments, and endpoints, randomization procedures, adverse event reporting, and protocol compliance monitoring. The ethical issues that arise at each phase of new biomedical product development will be explored. Practical exercises will include critical analysis of the informed consent form and development of a preliminary Investigational New Drug (IND) submission strategy to the FDA.

The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives:
• Discuss the FDA’s role in biomedical product development process
• Provide overview of regulations and guidance documents for drugs, devices and biologics submissions
• Discuss content and requirements for IND and Investigational New Device (IDE) applications
• Review the fundamentals of clinical trial structure and design, including Phase I, II, and III clinical studies
• Identify scientific and practical issues associated with the planning of clinical research study
• Describe the overall structure of a protocol and regulatory requirements
• Manage the timeline for protocols and their amendments, including internal and external review, key opinion leader input, collation, revisions, Quality Control (QC) process, sign-off/approvals, and meetings
• Discuss requirements for protection of human research subjects and their applications in responsible conduct of clinical research studies
• Discuss the requirements for pre-market New Drug Application (NDA) and Biologic License Application (BLA) and Pre-Market Application (PMA) content and regulatory process
• Explain the post-approval responsibilities of sponsors, including Phase 4 clinical studies

Course Outline:
• Module 1: Overview of Drug/Device Development Process for FDA Regulated Studies
• Module 2: Study Designs: Types of Observational Studies and the Basics of Prospective Design
• Module 3: IRB Regulations and Process, Informed Consent and the Regulations
• Module 4: INDs, the IND Process
• Module 5: Safety Monitoring for Clinical Trials
• Module 6: Statistical Considerations in Design and Analysis of Clinical Research Studies, Random and Systemic Error in Clinical Study Designs: Controlling for Bias and Confounders
• Module 7: Fundamentals of Trials with Medical Devices
• Module 8: Pre-Marketing Applications for Investigational Drugs and Biologics. Requirements for the NDA, BLA PMA
• Module 9: Review of Protocol Types, Special Designation Status (Multi-Center, Orphan Designation, Fast-Track), Post-Marketing Studies
• Module 10: Bioequivalence Studies for Development of Generic Drugs.