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

Course 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 basic 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.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. 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 and provide overview of regulations/guidance for submissions
• Discuss content and requirements for IND and Investigational New Device (IDE) applications
• Review the fundamentals of clinical trial structure and design
• Identify scientific and practical issues associated with the planning of clinical research study
• Describe the overall structure of a study protocol and regulatory requirements, including overview of regulatory guidelines to incorporate biomarkers, patient centricity, diversity into clinical study designs and protocol
• Manage the timeline for protocols and amendments, including internal and external review, key opinion leader input, patients feedback at drafting/pre-launch of the study, 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/Biologic Development Process for FDA Regulated Studies
• Module 2: Fundamentals 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: Basic 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, and 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 and Biosimilars for Biologics

Who Should Attend

• New Clinical, Regulatory, and Department Staff who will design clinical trial programs
• Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
• Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers
• Grant Administrators
• Medical Directors
• Medical Writers
• Clinical Research Associates
• Regulatory Affairs Professionals
• Research and Development Personnel

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Marina Malikova, PhD, MSci, MA, CCRA, RAC

Click here for complete trainer biographies

Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$1,795 by Early Bird Deadline

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-047-L99-P. Released: 8/23.  

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