This course addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between FDA and sponsors to provide clear direction to support marketing of the medical device.
- Address the ethical considerations involved in conducting clinical trials
- Strategically plan for successful clinical trials
- Develop trial objectives and hypothesis testing
- Develop protocols in accordance with regulations
- Evaluate basic statistical issues relating to sample size
- Distinguish and utilize assessment instruments
- Staff from medical device manufacturers or Contract Research Organizations (CROs) who will be involved in the design of clinical trials and have responsibility for protocol development
- Project Managers who have little or no clinical trial experience
- Project Team Leaders who will be designing clinical trials
- Clinical, Regulatory, and Development Staff who would like to learn how to design a clinical trial program
- Investigators who would like to learn how to design a clinical trial and about protocol development
Gary B. Freeman, M.S., C.C.R.A.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Historical Overview: Overview of the regulatory process; general ethical considerations
- Device Regulations Pertaining to Device Trial Design and Development: “Least Burdensome” approach in the USA; Europe; Japan; “Rest of World”
- Impact of ICH on Device Trials and Development: Principles of ICH/GCP
- Investigational Plan: Strategic Planning; Risk Analysis; Clinical Operations; Regulatory Planning: Marketing Considerations
- Trial Design Considerations: Definitions; types; randomizing; blinding or masking; outcomes
Day 2: 8:30 a.m. – 5:00 p.m.
- Trial Design Considerations, continued: Investigator Selection
- Protocol Structure and Format: Sections and sub-divisions
- Populations: Inclusion/Exclusion Criteria; Cultural Considerations\
- Determining Sample Size; Statistical Power: Qualitative and quantitative endpoints, equivalence, rare events; single group
- Objectives and Hypothesis Testing: Null vs. Alternative Hypothesis; Type I and Type II Errors; Single vs. Multiple objectives; statistical concepts for Non-diagnostic devices and diagnostic tests (IVD)
- Ethical Issues
- Case Studies: Improving Clinical Trials
- Control Groups
- Group Assignments
- Rationale Evaluation
- Protocol Modifications
- Sample Size
- Study Objectives
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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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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-006-L01-P. Released: 4/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.