Industries: Medical Device

Clinical Trial Design For Medical Devices™

Course Director: Glenda Guest

Course Description - Course runs 9:00 to 5:00 both days

Clinical studies are an integral part of the approval process for medical devices. While some devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate, with safety and effectiveness data in the target population, that the product is safe for human use.

This course offers an overview of the regulatory process for medical device applications, including medical device clinical trial design and implementation. Throughout, examples and case studies will help participants apply the concepts being covered.

Who Should Attend

This two day course is designed for Medical Device professionals involved in clinical trials. It is primarily designed to benefit the following disciplines and personnel:

  • Clinical Affairs
  • Medical Directors
  • Regulatory Affairs
  • Product Development
  • Project Managers

Course Agenda

First Day

Introduction to Clinical Trials

  • What is a clinical trial?
  • Why are clinical trials performed?
  • Types of clinical trials
  • Differences between medical device, drug, and biologic trials

Premarket vs. Post Market Clinical Trials

  • What is a premarket clinical trial?
  • Types of premarket clinical trials
    • Pilot (feasibility)
    • Pivotal
  • What is a post market clinical trial?
  • Types of post market clinical trials
    • Condition of Approval
    • Registry
    • Post Market Surveillance/522

How Claims for Medical Use Impact Trial Design

  • Intended Use
  • Indications for Use
  • Implied Claims
  • Comparative Claims

Protection of Human Subjects

  • Declaration of Helsinki
  • Informed Consent
  • Ethical considerations

Institutional Review Boards (IRB)/Ethics Committees (EC)

  • Purpose
  • Organization
  • Responsibilities
  • Records and reports

US and EU Premarket Regulatory Requirements

  • Significant vs. non-significant risk
  • Sponsor and Investigator responsibilities
  • Application contents
  • Report of prior investigations/Investigator Brochure and regulatory manuals
  • Additional requirements

Changes during the Conduct of the Trial

  • Supplemental applications
  • IRB/EC review
  • Informing patients

Regulatory Reporting and Record Keeping Requirements

  • Investigator and Sponsor records
  • Investigator and Sponsor reports

Second Day

Design of Clinical Study Protocols

  • Study objectives
  • Hypotheses, primary and secondary endpoints
  • Specific study population
  • Control groups
  • Inclusion and exclusion criteria
  • Sample size, selection of study sites, and investigators
  • Randomization plan
  • Treatment
  • Subject compliance and monitoring
  • Anticipated and unanticipated Adverse Effects
  • Follow-up procedures
  • Methods of analysis, including interim analysis
  • Methods for collection and validation of data

Preparation of Clinical Study Report

  • Study objectives and design
  • Specific study population
  • Control groups
  • Treatment
  • Methods of analysis and evaluation of data
  • Results
  • Comparison of results to success/failure criteria
  • Anticipated and unanticipated Adverse Effects
  • Deviations
  • Discussion of missing data and impact
  • Method of statistical analyses
  • Conclusions
  • Appendices (e.g., Data Listings, CRFs)

Learning Objectives

By the end of the course, participants will be able to:

  • Describe the various types of medical device clinical trials
  • Understand how clinical trial design impacts the marketing of a medical device
  • Understand the regulatory requirements associated with medical device clinical trials
  • Describe the essentials of coordinating, monitoring, and managing a clinical trial with an emphasis on complying with Good Clinical Practice
  • Understand how to develop a medical device clinical trial protocol and report.

Testimonials

"Best instructor to date, very knowledgeable with excellent communication and educational skills." Marie D., Manager, Regulatory Compliance, American College of Radiology
"This course director has an extensive knowledge base and experience in regulatory affairs, clinical research and compliance, which is communicated very effectively to course attendees. This has enabled me and inspired me to pay greater attention to detail in the course of my clinical research activities as a multi-center trial P.I. than ever before. Thank you!." Dr. Alexander S., Colonel, Walter Reed Army Medical Center
"The course was fantastic. It was the best medical device course I have attended." David H., Clinical Trials Coordinator, Cook Biotech Inc.
"The Course Director was very knowledgeable and accommodated all of our questions and was also available during breaks and after class for questions." Denese S., Clinical Research Associate, Covidien
"The course was very informative. The Course Director was well informed and conveyed a wealth of experience in the practical application of course material." Alastair R., Doctor, D3 Technologies
"This course was very beneficial and went into more detail that I expected. The real life examples were great. The instructor did a nice job of keeping the class engaged and attentive. This was a useful course and I would recommend it." Jennie R., Clinical Research Associate, Ocular Therapeutics