Statement of Task (Part II): Identify potential research approaches, methodologies, and study designs that could inform this question, including an assessment of the potential strengths and limitations of each approach, methodology, and design, as well as the financial and ethical feasibility of doing them.
Summary of Methodological Issues
The committee’s findings and conclusions about research approaches are presented in Chapter 6. The committee parsed the phrase “this question” in Part 2 of the statement of task into four broad research questions in Box 7-1.
The committee then discussed general research approaches with the potential to answer these questions: ongoing research with data from existing data systems, research with enhanced data from existing data systems, prospective observational studies, and randomized controlled trials. The committee also recognized that to advance the knowledge about the safety
Leading Research Questions of Interest to Select Stakeholders