Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.
About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.
In November 2013, the FDA released guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices outlining information on design issues for pivotal clinical trials. The guidance provides general principles for different types of study design that will meet FDA’s expectations for premarket clinical data requirements; however the FDA has stressed that the guidance is not meant as a “comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies.” With the new guidance in mind, this 2 part session will delve into proper design and execution for clinical outcome studies and diagnostic clinical performance studies and the factors to be considered for each type.
- Choosing the correct study design for the test
- Bias and variability considerations in diagnostic performance
- Best practices in outlining study objectives, subject selection & site selection
- Incorporation & FDA considerations of comparative study design
Consulting Vice President, Clinical Operations
Participants that will find this webinar most beneficial will be those involved in diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Regulatory Operations
- Clinical Trials
- Clinical Operations
- Companion Diagnostics
- Quality Affairs