Design and Conduct of Clinical Trials: Design Requirements, Statistical Issues, and Clinical Protocols

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Course Description

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


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

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

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Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

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

Day Two: 8:30 a.m. – 5:00 p.m.

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

Interactive Activities

  • Review and identification of elements of Informed Consent
  • Develop a preliminary Quality by Design (QbD) strategy and apply Quality Risk Management (QRM) perspective to develop baseline quality metrics and key risk indicators based on specific study protocol

Registration Fees

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 Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-18-004-L01-P. Released: 6/18.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.