Jun 29, 2023 | Publications and Posters
Purpose SDTM, or Study Data Tabulation Model, is one of the required standards for data submission to the US Food & Drug Administration (FDA). Manually mapping data fields from a clinical trial database to their corresponding SDTM fields has increased statistical...
Jul 12, 2018 | Publications and Posters
ARVO Annual Meeting, May 2018 Poster Missing data is a common occurrence when collecting patient responses via patient symptom diaries. Many methodologies exist for imputing missing data and are used to estimate statistical outcomes that would have been achieved had...
Jul 11, 2018 | Publications and Posters
ARVO Annual Meeting, May 2012 Poster This research focuses on improving the accuracy associated with estimating the number of medical history (MedHx), concomitant medications (ConMeds), and adverse events (AEs) terms and related discrepancies for dry eye and ocular...
Jul 11, 2018 | Publications and Posters
ARVO Annual Meeting, May 2012 Poster Sample size and power estimation are essential aspects of clinical trial design. The techniques used to generate these estimates often involve complex statistical calculations and statistical software. Clinical personnel do not...
Jul 11, 2018 | Publications and Posters
ARVO Annual Meeting, May 2012 Poster Ophthalmic clinical trials often involve multiple comparisons of different treatment regimes. For example, drug combinations are often compared to their components alone, as well as to the vehicle. Such studies require performing...
Jul 11, 2018 | Publications and Posters
ARVO Annual Meeting, May 2012 Poster Patient symptom diaries are a commonly used method to collect efficacy data in clinical trials, such as those for dry eye treatments. Typically, patients are asked to report symptom severity several times per day over the course of...
