High Yield Biostatistics cation Excelence Week 2010 ‘Chayan Chakrabor, MD g ‘Which of the following is true concerning Phase IV trials? 2) Torino such ing a2 Prac Vt ©) Bate al ar oy aot in 6) Phase alsin post matting Clinical trial stages Page 1 — small of heath volunteers psessce pel fowl), ond pharmaco 1age2- smal #of patents, assesses Phy doang sh sovecse Secs Phage 3 lage RCT, compares new to Normal (Gaussian) distribution eee Sei ARETE Gaandaem prose pst natetingsureance i I — ‘Standard deviation 1H eee soon neesnn oo ea ATT, + manne se sp= Ee: iy \ Sea jbo‘Standard deviation Wri ondesamejecit fave: dooumventod scores at least 2°60 Sr eights Yor amssion O12 sip 35 "dado Zandomiy slate howe ‘many woud be ehgbie? Dr 9 9 Standard deviation Membershig in a medical nonor society is Desodon ass seotes. Only toe he ave decumented scares ot leaet 2°63 Ee cues’ aimesar Olay ot iden anaamiy selects, how ‘any Wd eg 28D =2.5% of sample = 0025 * 200 a2 bso [ay] 9 Standard error of the mean (SEM) sen ~ sD F "CSRS Bosal ig, g,gamole of 400 heathy moda ‘Badente mean hear ate fund Be. opm with @ 36 ot $0: Wha 350 CT se papuisr g From samples to populations In 2 sample of 400 heat'y medical ‘Sudeni De tnean an ile b Gi 0 beeen wh 5 of 8: Vat ie BBL GPP population SEM = sb = 39, ve Yéoo 20 Om 5 + 95%6c1 Wang Faro 9Hypothesis testing 2005 02 jos a)095 Hypothesis testing + Nut hypotness (HO) “No irene Between groups ts + Research hypothesis (11) SA rence between gps eit 9S Errors + Type | alpha) eros: ~Epgna#terene when ore dos nt bh has gour Sats rate + Type I (beta errs: Notsedingaaterence when ne dos smmaee Hypothesis testing 005 v0.2 jos fase A incall as conducted compa ative parkas cect ean No esis owe rove fol aA ce, Bete 3M sthe roa of Making a Type soc? Bias 2) 0 8)0% c)043 [a)a3] e087 5+ Since al pateis came tom acho ‘Ttercnay qn sopeney ono Research Design febponce clo uaslon doyser Rave you srr sched oa + This is selection bas (9) 8 8 Alpralaie oy nos2cee ay as 2ct Sree ena Research designs et oat OF omni a conga zor rire one Sarah ts Serres mitts Soh Seis poe cont soi Case-contol— compares a group wit icease toa group wihoul ease (Case contol cohort cross sectional (Cross sectional ~ cles data fom 9 Case series | crossover Phase t Population ata singe time point og 9 Experimental trials Compares therapeu efecto wo or + Example Fandomed contol il (RCT) + Group of 100 patents ‘sree madison ‘ower ‘rca pocabotarate eroy 6) met-anayss g 8Meta-analysis + pnt eal se mes Seton ~ Ree gaan rig 9 Ccase-contl CononiRer cross sectional + Case-contol ask “what happened” + Cohort & RCT ask what will happen + Goss sectoral: desertion of point in 9 ‘Odds Ratio vs Relative risk + Case-contol study > uses odds rato Ex Patents wth COPD na ne ao Sheregrenna an aos + RT cohort study > ses relative risk x Sorta 2 hohe sk of dewione 9 Relative risk vs Odds Ratio ~ Picardo sengnes gexaan aa {Rpts mid aoe estoy ane yout” Gulcemes’ cardiovascular death Broke ora wm [ine] ae] 104065 = 0.108 Onra=0-66=073 Evaluating diagnostic tests The 2x2 square 9Relative risk vs Odds Ratio + Anew testis recommended for Scfeontng A fit of 4000 patients were Subjected othe test ana asus are the bie Vinatethe tox sanstay? 9 Relative risk vs Odds Ratio + Anew testis recommended for ‘efeontng A (lt of 4600 pattnts wore ‘Subjected i ve test ana eau ore ‘he lable Vnat ste test sensivty? 1200120040) 7 + Sorat and spect ace ater siamo cae rd pusher” ae “roe Smeenasas ams Sse y Number needed to treat (NNT) Seep A gen Trainer for isase Copap gear Daan ‘Sit 1000 ie of Daease + How many patents need tobe treated vith eater to prevent one desh NNT + Sin 1000 eit treatment (placebo) +n 1000 det Treatment x + THUS: 4in 1000 saved if treated + NNT= 11 Absolut Risk Reduction = NNT= 1/004 = 250 must be treated to byore ONE westReceiver Operating Characteristic 5 statistical test you should (ROC curve) know om ss Hest tests the difference between means ‘of wo groups. ‘ngs ol atonce (ANOVA) este ne ‘ore groups | ‘Chigquar test: both variables re Calcboral CCoreation: ranges from -1.00 to +1.00 Top let comer i bes, (a) ony Regression (predicton) what are the “9 ‘Sore for an Mi?