At the February 2014 meeting, background presentations were presented by authors of the meta-analyses and observational studies, FDA officials, industry representatives, as well as guest speakers, including the lead investigator for the PRECISION trial.
The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval).
Therefore, planners of the 2010 roundtable included several background presentations in the agenda.
Each meeting began with introductions, background presentations and an explanation of goals and objectives for the session.
This overview provides a roadmap for the background presentations during the roundtable meeting and the roundtable dialogue that followed these presentations during this workshop.
Therefore, the roundtable's dialogue did not cover all possible topics and the group did not necessarily take time to resolve differences of opinion in the background presentations.
In past NHANES expert panel meetings, the background presentations provided detailed descriptions of the NHANES measurement procedures (ie, quality controls and performance characteristics) and crossover study results, with appropriate adjustment equations when measurement procedures changed.
Following the successful formats that prior NHANES-related expert panels have used (1), the PC organized the roundtable meeting agenda to include a combination of background presentations and dialogue sessions.
The first 2 background presentations, by Elizabeth Yetley of the ODS and Joseph Massaro of Boston University (Table 2), covered the history and use of folate and vitamin B-12 biomarkers in NHANES, the key scientific challenges that previous expert panels identified when they examined folate-related biomarkers in NHANES, and statistical issues of key importance to NHANES users.
