Common use of STATISTICS FOR SECONDARY STUDY OBJECTIVES Clause in Contracts

STATISTICS FOR SECONDARY STUDY OBJECTIVES. SECONDARY OBJECTIVE 1: Test the hypothesis that, on average over the study period, patients' PSA values will trend downward compared to screening values. Each subject is assayed eight times at various times between day 1 and week 26. Regression analysis using Generalized Estimating Equations (GEE) is used to test for trend of improvement over the study period. 38 SECONDARY OBJECTIVE 2: Describe how the patient's experiences of pain, physical functioning and quality-of-life measures change during the course of treatment and during the follow-up period. For each patient over the study period pain is assessed five times using the Brief Pain Inventory, physical functioning is measured six times using both the Karnofsky and Zub▇▇▇ ▇▇rformance Scales, and quality of life assessments are obtained five times using the FACT-P questionnaire. Patient averages at screening and during the study weeks is graphed and the trends and tempos of these repeated measurements is modeled and analyzed using GEE. SECONDARY OBJECTIVE 3: Describe how the patient's skin test and other lab results change during the course of treatment and during the follow-up period. For each patient over the study period skin tests are assessed four times using four recall antigens (Candida, Mumps, and PPD) and CBC, differential blood chemistry and serum markers are measured nine times. Patient averages at screening and during the study weeks are graphed and the trends of these repeated measurements are modeled and analyzed using GEE.