1. 1 Sarah Fowler Res. Professor of Biostat. & Epi. Director, Biostatistics Center PhD in Mathematical Statistics Specialties: statistical design, conduct, and analysis of multi- center clinical trials Funding: NIH/NIDDK,NHLBI fowler@biostat.bsc.gwu.edu 301-881-9260

2. GWU Biostatistics Center Established 1972, Statistics Established 1972, Statistics Faculty affiliations in SPHHS/DEB Faculty affiliations in SPHHS/DEB Administratively in office of EVPAA Administratively in office of EVPAA 12 faculty, 150 + employees 12 faculty, 150 + employees Research awards to BSC investigators: $63 million/ year Research awards to BSC investigators: $63 million/ year 16 grants and contracts, duration 3 years – 40 years 16 grants and contracts, duration 3 years – 40 years

3. 3 Diabetes Prevention Program Interventions to prevent/delay onset of Type II DM in 3234 subjects at high risk Interventions to prevent/delay onset of Type II DM in 3234 subjects at high risk Groups compared: lifestyle (ILS), metformin, and placebo Groups compared: lifestyle (ILS), metformin, and placebo Results: T he DPP Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 346:393- 403, 2002. Results: T he DPP Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 346:393- 403, 2002. Cohort being followed for 10 years, ending in 2012 Cohort being followed for 10 years, ending in 2012

4. 4 Results of the DPP 158,000 screened, 3819 enrolled PlaceboMetformin Life-style Incidence of diabetes 11.0% 7.8% 4.8% (percent per year) (percent per year) Reduction in incidence ---- 31% 58% compared with placebo compared with placebo Number needed to treat ---- 13.96.9 to prevent 1 case in 3 yrs to prevent 1 case in 3 yrs Results are similar across ethnic groups Results are similar across ethnic groups

5. 5 Pulmonary Embolism Diagnosis PIOPED II: diagnostic accuracy of multi-detector spiral CT angiography/venography PIOPED II: diagnostic accuracy of multi-detector spiral CT angiography/venography 773 patients evaluated by CT and reference 773 patients evaluated by CT and reference Stein PD, et al. Multidetector Spiral CT For Acute Pulmonary Embolism: Results Of The PIOPED II Trial. N Engl J Med 2006; 354:2317-27 Stein PD, et al. Multidetector Spiral CT For Acute Pulmonary Embolism: Results Of The PIOPED II Trial. N Engl J Med 2006; 354:2317-27 ResultsSensitivitySpecificity CTA alone: 83%(76-92)96%(93-97) CTA/CTV:90%(84-93) 95%(92-96) CTA/CTV replaces more invasive tests PIOPED III: evaluating MR angiography/ venography (can be used in pregnant women and patients with renal disease) PIOPED III: evaluating MR angiography/ venography (can be used in pregnant women and patients with renal disease)