The Clinical Data Management Process

Jul 10, 2018 | Publications and Posters

ARVO Annual Meeting, May 2012 Poster Approval of new retina drugs by the US Food and Drug Administration (FDA) is contingent upon trust and belief that clinical trial data are of sufficient integrity. From database build to database lock, clinical data management...

Power and Sample Size Calculations for Primary Open Angle Glaucoma / Ocular Hypertension Clinical Trials Accounting for Correlation of Measures among the Time Points across Visits

Jul 10, 2018 | Publications and Posters

ARVO Annual Meeting, May 2012 Poster Historically, the correlation among time points within a subject/eye and the requirement of a majority of time points having an upper 95% Confidence Interval less than 1 mmHg has not been overtly accounted for when determining...

Statistical Methods for Non-Detectible Data in Tear Cytokine Measurements

Jul 10, 2018 | Publications and Posters

ARVO Annual Meeting, May 2012 Poster There are many instances in which laboratory measurements have limits of detection. The results for such tests will be reported as “< d” where d represents the limit below which measurements cannot be (reliably) obtained. A...

Adaptive Clinical Trial Designs

Jul 9, 2018 | Webinar

Recorded June 13, 2017 Webinar On Demand Trends in Protocol Design Practice and Optimization Presented by: Ken Getz, Director of Sponsored Programs at the Center for the Study of Drug Development, Tufts University School of Medicine The scientific and operating...

Optimizing Your Clinical Development Strategy by Identifying Promising Subgroups for Patient Enrichment

Jun 26, 2018 | Webinar

Webinar On Demand In many clinical trials, we seek to identify a subgroup of patients in which an active treatment is most effective compared to a control. These high-efficacy subgroups may influence the enrollment criteria for future clinical trials and can change...