6-Hour Virtual Seminar on Design and Conduct of Clinical Trials – Design Requirements, Statistical Issues, and Clinical Protocols

Clinical trials play a pivotal role in evidence-based medicine. This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical research. Topics will include basic principles and current methodologies used in the design, implementation, and analysis of clinical trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, assignment of study treatments, endpoints, randomization procedures, sample size determination, data analysis, adverse event reporting, and protocol compliance monitoring. The ethical issues that arise at each phase of new biomedical product development will also be explored.

Learning Objectives:

  • Describe study designs and their limitations
  • Identify scientific and practical issues associated with the planning of a clinical research study
  • Manage protocol structure, outline, timeline, and amendments
  • Discuss requirements for protection of human research subjects
  • Review statistical issues in design and analysis of clinical research studies
  • Develop a basic statistical understanding (e.g., qualitative and quantitative data, sample size determination, and interim analysis)

Who Should Attend:

  • New or Novice Project Managers
  • Clinical Department Staff
  • Regulatory Department Staff
  • Research and Development Department Staff
  • Clinical Research Associates
  • Data Managers
  • Staff interested in transitioning into clinical trial management
  • Grant Administrators
  • Medical Directors
  • Medical Writers
  • Everyone who design clinical trial programs

FDB3380

Marina Malikova

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

Session 1

  • Overview of Drug/Device Development Process for FDA Regulated Studies
  • An Introduction to Design and Conduct of Clinical Trials
  • Research Ethics and Informed Consent
  • Clinical Trial Protocol Requirements
Session 2

  • Types of Observational Studies
  • The Basics of Prospective Design
  • Selecting a Study Population
  • Safety Monitoring for Clinical Trials
Session 3

  • Statistical Considerations in Design and Analysis of Clinical Research Studies
  • Systemic and Random Errors, Bias and Confounding, Test Qualities
  • Fundamentals of Trials with Medical Devices
  • Requirements for Biologics License Application (BLA)
Session 4

  • Special Designation Status (Multi-Center, Orphan Designation, Fast-Track)
  • Post-Marketing Studies
  • Quality by Design (QbD), and Risk-Based Monitoring (RBM)
  • Quality Risk Management (QRM), and Key Performance and Quality Indicators (KP-QIs)

membership

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
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