Mastering IVD Clinical Trials: Part 1 - The Basics

This eConference is the first in a four-part series presented by renowned experts Dr. Cheryl Hayden and Dr. Robert Thiel.  

 

Objective:
Introduce those principles of clinical trial design that are unique for in vitro diagnostics. 

Why should I take this eConference:
Because in vitro diagnostic trials are structured differently than other device or drug trials, you need to understand those differences in order to meet regulatory and marketing needs.

You will learn:
- How to structure a trial to evaluate a diagnostic test.
- What an endpoint is and its importance.
- How to ensure that your trial actually addresses the proper scientific question.
- What statistical questions must be addressed.
- Where can I find tissue sample banks?
- When is informed consent required?
- When is IRB review required?
- Can I get expedited review?
- Pitfalls to avoid

Who should attend:
Anyone who will be involved in IVD clinical trial design and management, such as:
- In vitro diagnostic Manufacturers
- Sponsors
- Monitors
- Regulators
- CRO personnel
- IRB personnel
- Laboratory personnel

You will receive:
- Slides
- Handouts
- Protocol template
- FDA Guidance on Informed Consent for IVD Device Studies…
- An expert speaker
- A chance to listen to other's QnA
- CEUs & Certificate

Presenter:
Clinical Device Group is proud to present Dr. Cheryl Hayden. Dr. Hayden has degrees in medical technology, biostatistics, and microbiology. She has worked for 25 years in the field of clinical research, 8 years in a consulting capacity. Much of her experience is with in vitro diagnostics. She was involved in early work with tumor markers, determining the utility of these assays and raising awareness of their use in the oncology community. She has published several papers on trial design for IVDs, specifically on nested endpoints and flaws of gold standards. Dr. Hayden’s interest in IVD trial design stems from her early training in medical technology. Dr. Hayden can be reached at Cheryl.hayden@comcast.net.

The purchase is $402 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.