Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Recognize the need for new statistical methods Learn the advantage and disadvantages of the new statistical method Learn how do we weight historical data Learn the difference between fixed vs dynamic borrowing of data
Roseann White, PhD Director of Pragmatic Clinical Trials, Duke Clinical Research Institute Learning Objectives Recognize the importance of collaboration among scientist, statistician, and regulatory personnel Understand the importance of data collection to product coherent body of evidence about product safety, efficacy and effectiveness Learn the concept of data aggregation Learn the concept of the frequentist […]
Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Recognize the type of studies needed in translational research from proof of concept to post market studies Understand the goal of proof of concept study
Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Understand the difference in trial design – single arm vs parallel RCT vs crossover RCT Understand the rational and the concerns about the single arm trials Learn the advantages of the randomized control clinical trials Learn the advantages and disadvantages of crossover RCT Understand the […]
Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Understanding the meaning of sensitivity Understanding the meaning of specificity Learning the meaning of positive predictive value Learning the meaning of negative predictive value Recognizing the impact of sample size on confidence interval
Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Understand that sample size and power minimize the chances of type II error Learn about sample size, effect size, variation of measurement and power Understand the relationship between sample size, effect size, and variation of measurement Understand the meaning of confidence level
Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Understand the meaning of P value Learn the logic of hypothesis testing Understand type I and type II errors Learn the disadvantage of multiple testing
Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Learn basic statistical concept Understand the randomized control clinical trial Understand the impact of multiple testing Learning the important questions and endpoints according to the stage of the translational pathway of a therapy
David Reuter, MD Director, Cardiac Innovation, Seattle Children’s Hospital Learning Objectives Understand the technical challenges and risk management Understand the importance of optimizing communication Learn the difference between innovation and research Understand the concept of design freeze
Andrew Farb, MD Medical Officer, Interventional Cardiology Devices Branch, FDA Learning Objectives Understand the importance of EFS in device development Understand the components of EFS Learn the limitation of non-clinical testing and doing the right test at the right time Learn the EFS pre-IDE submission timeline and goals Learn how EFS can expedite product approval […]
