Statistical Considerations for IVD Studies

Why should you take this eConference?
Sensitivity, specificity, prevalence, predictive value, outcomes, clinical utility, reproducibility, stored specimens, specimen banks, linked data, de-identified data...in vitro and in vivo diagnostic trials have a totally unique vocabulary that doesn't even exist for other clinical trials. If you work in this diagnostics, you need to speak it.

You will learn:
1. What these words mean.
2. Why clinical trials cannot be replaced by benchtop tests.
3. When, if, and why informed consent is needed.
4. When, if, and why IRB review is needed.
5. Some differences between in vitro and in vivo diagnostic.
6. Basic study designs.
7. Basic statistical considerations.

Objective:
Diagnostic clinical trials aren't like other clinical trials. With in vitro trials, for example, the device never touches the patient. With both in vitro and in vivo devices you care about establishing what's so and about predicting the future. We have two objectives for this conference: 1) to review the language of diagnostic trials and how to apply Part 812, and 2) to learn the basic trial designs and statistical considerations.

You will receive:
1. Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers.
2. PowerPoint slides from Nancy Stark's presentation.
3. PowerPoint slides from Michelle Secic's presentation.
4. Certificate of attendance and 0.2 CEUs.

Presenters:
The webinar will be presented by Dr. Nancy J Stark and Ms Michelle Secic. Ms. Christine P. Bump, Esq., will moderate the session.

Dr. Stark was selected as one of 100 notable people in the medical device industry by Canon Communications in 2004. You can learn more about her at http://www.nancystark.com.

Michelle Secic is the President of Secic Statistical Consulting, Inc. where she works on a variety of medical research projects. The second edition of her book, "How To Report Statistics in Medicine" was released in 2006. Ms. Secic can be reached at consult@secicstats.com

Christine P. Bump is an associate with Hyman, Phelps & McNamara, P.C. in Washington, D.C. Christine’s practice is focused in the areas of devices, including in vitro diagnostic devices, and product advertising and promotion. Prior to joining Hyman, Phelps & McNamara, P.C., she served as a law clerk at the Centers for Disease Control and Prevention’s Office of General Counsel and as a Policy Fellow at the CDC’s Center for Environmental Health. Christine earned a law degree and a Master’s in Public Health from Emory University’s Schools of Law and Public Health. There, she served as Executive Managing Editor of the Emory International Law Review. Christine earned a B.A. in Government, summa cum laude and with high honors, from Sweet Briar College. Ms. Bump can be reached at CBump@hpm.com.

The purchase is $495 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.2 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.